[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tianjin Medical University Cancer Institute and Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":548},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,190,0,25,[9,38,63,83,108,127,145,164,185,209,229,249,267,286,303,322,342,364,387,420,444,462,483,500,531],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100645246",false,"NCT07681817","Risk Stratification and Proactive Nursing Intervention for Acute Kidney Injury Following Interventional Therapy in Patients With Liver Cancer","Inclusion Criteria:\n\n* Completed eligibility screening in Phase I of the study\n* Completed AKI risk assessment using the established prediction model\n* Classified by the model as at risk for AKI (moderate- or high-risk patients prioritized; low-risk patients included only for exploratory\u002Fobservational analysis)\n* Conscious and able to communicate effectively\n* Able to understand and comply with nursing interventions\n* Expected hospital stay of at least 3 days\n* Available for postoperative follow-up\n* Provided written informed consent jointly with a primary caregiver\n\nExclusion Criteria:\n\n* Development of AKI within 24 hours after interventional therapy according to KDIGO criteria\n* Severe psychiatric disorders, cognitive impairment, or communication barriers preventing participation in HBM-based assessment or intervention\n* Requirement for postoperative ICU admission and continuous life-support therapy\n* Mandatory use of nephrotoxic medications that cannot be discontinued, substituted, or adjusted during the study period\n* Participation in other clinical intervention studies that may affect renal function or nursing outcomes","ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study focuses on the early identification and precision prevention of acute kidney injury (AKI) following interventional therapy in patients with liver cancer. A prospective, phased mixed-methods research design will be adopted. In the first phase, a prospective cohort study will be conducted to systematically collect clinical and nursing-related data. A Super Learner ensemble algorithm will be employed to develop and validate an AKI risk prediction model, enabling precise risk stratification of patients. In the second phase, a prospective randomized controlled trial will be implemented. Guided by the Health Belief Model (HBM), a risk-stratified proactive nursing intervention will be delivered, and its effectiveness will be compared with that of routine nursing care in reducing the incidence of AKI, improving adherence to hydration protocols, optimizing the management of nephrotoxic medications, and enhancing patients' self-management capabilities. By integrating intelligent risk prediction with proactive nursing intervention strategies, this study aims to establish a reproducible and scalable precision prevention and management model for AKI in liver cancer patients undergoing interventional therapy. The findings are expected to provide scientific evidence for early AKI warning and proactive nursing practice, thereby promoting the precision, intelligence, and standardization of oncologic interventional nursing care.",[25],"Liver Cancer, Adult","NOT_YET_RECRUITING","2026-06-30",{"date":29,"type":30},"2026-07-02","ACTUAL",{"date":32,"type":19},"2026-07-01",{"date":34,"type":19},"2028-12-31",{"name":36,"class":37},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"id":39,"slug":4,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":20,"phases":46,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100645373","NCT07681128","The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy","The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy: A Prospective Single-center Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female;\n* Scheduled to undergo curative pancreaticoduodenectomy (PD);\n* Undergoing PD for malignant or borderline tumors, with planned antecolic Billroth II reconstruction;\n* Mentally competent and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Prior diagnosis of gastroparesis;\n* Benign disease as the indication for PD;\n* Previous history of upper gastrointestinal surgery;\n* Preoperative pyloric obstruction;\n* Planned pylorus-preserving pancreaticoduodenectomy (PPPD);\n* Patients who have received neoadjuvant or conversion therapy;\n* Preoperative glycated hemoglobin (HbA1c) \\> 7.5%;\n* Preoperative total bilirubin level \\> 200 μmol\u002FL;\n* Unable or unwilling to provide written informed consent.",{"count":45,"type":19},264,[22],"Pancreaticoduodenectomy (PD) is the only curative procedure for periampullary malignant tumors. Although modern perioperative management has greatly reduced postoperative mortality, delayed gastric emptying (DGE) remains one of the most common and troublesome complications after PD, with an incidence up to 30%. DGE leads to abdominal distension, nausea, vomiting, intolerance of oral diet, prolonged hospital stay, increased medical costs, delayed adjuvant therapy initiation, and impaired long-term nutritional recovery and quality of life.\n\nBraun anastomosis (BE) can reconstruct the gastrointestinal tract by side-to-side jejunojejunostomy between the afferent and efferent limbs, which may reduce intestinal stasis, bile reflux and afferent limb obstruction, and theoretically lower the risk of postoperative DGE. However, current clinical studies and meta-analyses remain controversial regarding the actual efficacy of BE in preventing DGE after PD. Some studies support that BE can reduce DGE incidence, shorten hospitalization and improve postoperative recovery, while others demonstrate no statistically significant benefit, or even concern about prolonged operative time and technical difficulty. Existing evidence is limited by small sample size, retrospective design and potential selection bias, and high-quality prospective randomized controlled trials are still lacking to confirm the clinical value of BE.\n\nThis study is designed as a prospective, single-center, randomized controlled trial, aiming to evaluate the impact of routine Braun anastomosis during digestive tract reconstruction on the incidence and severity of postoperative DGE in patients undergoing pancreaticoduodenectomy for malignant tumors. The results will provide high-level clinical evidence for the rational application of Braun anastomosis in PD reconstruction and guide standardized clinical practice.",[49],"Periampullary Carcinoma Resectable",[51,52,53],"Pancreaticoduodenectomy","Braun Anastomosis","Delayed Gastric Emptying","RECRUITING","2026-06-26",{"date":29,"type":30},{"date":58,"type":30},"2026-03-30",{"date":60,"type":19},"2028-09-30",{"name":36,"class":37},1,{"id":64,"slug":4,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":69,"minAge":16,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100644514","NCT07670182","The Efficacy of Combined Peripheral Blood CTCs and Serum HER2 Detection in Docetaxel-based Treatment for HER2 Low-expression Breast Cancer","A Prospective, Multicenter Clinical Study on the Efficacy Correlation of Deruxtepruzumab Treatment for Advanced Breast Cancer With Low\u002FUltra-low HER2 Expression, Guided by Peripheral Blood CTCs\u002FCTECs Combined With Serum HER2 Detection","Inclusion Criteria:\n\n1. Patients with a pathological record of breast cancer;\n2. Group A: Diagnosed with low expression of HER2 (IHC 1+ or IHC 2+ and ISH-); Group B: Diagnosed with HER2 0 expression (IHC 0);\n3. No history of other malignant tumors;\n4. Signed the informed consent form at the age of 18 or above;\n5. Possess relatively complete clinical case characteristic data.\n\nExclusion Criteria:\n\n* 1\\. Male breast cancer patients; 2. Pregnant or breastfeeding; 3. Patients known to have an allergic reaction to the active substances or any excipients of T-DXd; 4. Patients judged by the investigators to be unsuitable to participate in this study.","FEMALE",{"count":71,"type":19},100,"OBSERVATIONAL","This study is a multicenter, double-cohort clinical research aimed at systematically evaluating the value of jointly detecting the HER2 expression of CTCs\u002FCTECs and the serum HER2 ECD level in predicting the efficacy of T-DXd treatment for patients with HER2 low expression (IHC 1+ or IHC 2+\u002FISH-) and HER2 IHC 0 advanced breast cancer.",[75],"Patients With Low HER2 Expression (IHC 1+ or IHC 2+\u002FISH-) and HER2 IHC 0 Advanced Breast Cancer","2026-06-24",{"date":55,"type":30},{"date":79,"type":19},"2026-06-15",{"date":81,"type":19},"2031-01-01",{"name":36,"class":37},{"id":84,"slug":4,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":20,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":62},"100644622","NCT07670715","Phase II Trial of SFRT Plus Chemo-immunotherapy for LA-NSCLC With Suboptimal Neoadjuvant Response","Spatially Fractionated Radiotherapy Combined With Chemo-immunotherapy for Locally Advanced Non-Small Cell Lung Cancer With Suboptimal Response to Initial Neoadjuvant Therapy: A Single-Arm, Open-Label, Phase II Study","Inclusion Criteria:\n\n1. Histologically confirmed unresectable stage III locally advanced non-small cell lung cancer (LA-NSCLC).\n2. Received at least 2 cycles of standard neoadjuvant chemoimmunotherapy, with suboptimal tumor response verified by post-induction radiological evaluation.\n3. Age ≥ 18 years old.\n4. ECOG performance status of 0 or 1.\n5. Adequate hematologic, hepatic and renal function to complete radiotherapy and consolidation systemic therapy.\n6. Voluntarily sign written informed consent and be capable of following study-related procedures.\n\nExclusion Criteria:\n\n1. Prior thoracic radiotherapy history.\n2. Active uncontrolled autoimmune disorders or persistent severe immune-related adverse events.\n3. Untreated symptomatic brain metastases.\n4. Severe irreversible cardiac, pulmonary, liver or renal dysfunction that cannot tolerate combined radiotherapy and immunotherapy.\n5. Pregnant or breastfeeding women.\n6. Concurrent or previous other malignant tumors within 5 years, except cured basal cell skin cancer and cervical carcinoma in situ.\n7. Any absolute contraindication to lattice radiation therapy or immune checkpoint inhibitor.",{"count":90,"type":19},30,[92],"PHASE2","Lattice radiation therapy (LRT) is a spatially fractionated thoracic radiotherapy technique that creates alternating high- and low-dose regions within primary lung tumors and metastatic lymph nodes to strengthen local tumor suppression and reduce radiation injury to normal thoracic organs. This study aims to evaluate the efficacy and safety of combining LRT with consolidation chemoimmunotherapy in unresectable stage III LA-NSCLC patients who show suboptimal tumor response to prior neoadjuvant chemoimmunotherapy, through a single-arm Phase II clinical trial. Patients will receive thoracic LRT delivered by a medical linear accelerator. High-dose spherical sub-targets will be contoured within the gross tumor volume of primary lung lesions and regional nodal metastases under standardized dose constraints to spare the lung, heart and esophagus. All enrolled subjects will receive sequential consolidation chemoimmunotherapy administered within one week after finishing LRT. Tumor response, treatment-related adverse events, local tumor control and long-term survival outcomes will be prospectively tracked throughout treatment and long-term follow-up.",[95,96,97,98],"Locally Advanced Non-small Cell Lung Cancer (NSCLC)","Thoracic Radiotherapy","Immune Checkpoint Inhibitors","Neoadjuvant Chemoimmunotherapy",[100,101,98],"spatially fractionated radiotherapy","Locally Advanced NSCLC","2026-06-22",{"date":55,"type":30},{"date":32,"type":19},{"date":106,"type":19},"2028-07-01",{"name":36,"class":37},{"id":109,"slug":4,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":20,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":124,"leadSponsor":126,"locationsCount":62},"100644115","NCT07665190","Neoadjuvant EGFR-ADC Combined With Anti-PD-1 Monoclonal Antibody in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma","A Multicenter, Phase II Clinical Trial of Neoadjuvant Becotatug Vedotin Combined With Pucotenlimab in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma","RESERVE-HC","Inclusion Criteria:\n\n1. Aged ≥ 18, male or female;\n2. Histopathologically confirmed Hypopharyngeal Squamous Cell Carcinoma;\n3. Surgically resectable, Clinical Stage III or IV and no distant metastasis (AJCC 8th edition);\n\n3\\. Measurable primary lesions per RECIST v1.1; 5.Treatment-naive (no prior anti-tumor therapy for current disease); 6.ECOG performance status 0-1; 7.Estimated life expectancy \\>= 3 months; 8.Have adequate organ function as defined by laboratory parameters; 9.No contraindications to chemotherapy, targeted therapy, or immunotherapy; 10.No history of immune-related diseases; 11.No uncontrolled pneumonia or pulmonary infection; 12.Female participants of childbearing potential must agree to use effective contraception during the trial; A serum or urine pregnancy test must be negative within 72 hours prior to the start of chemotherapy; 13.The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis;\n2. Patients with uncontrolled severe medical conditions;\n3. Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies;\n4. Uncontrolled cardiac clinical symptoms or diseases;\n5. Occurrence of severe infection (CTCAE Grade \\> 2) within 4 weeks prior to the first dose of the study drug;\n6. Unexplained fever \\> 38.5°C during the screening period or before the first dose;\n7. Active autoimmune disease or a history of autoimmune disease;\n8. History of immunodeficiency, or a history of organ transplantation or allogeneic bone marrow transplantation;\n9. Patients with untreated chronic hepatitis B, or chronic hepatitis B virus (HBV) DNA exceeding 500 IU\u002FmL, or patients with active hepatitis C virus (HCV) must be excluded;\n10. History of interstitial lung disease;\n11. Patients with active pulmonary tuberculosis infection identified by medical history or CT scan;\n12. Patients who have received any of the following treatments:\n\n    A. Receipt of any investigational drug or anti-cancer therapy within 4 weeks prior to the first dose of the study drug; B. Requirement for systemic treatment with corticosteroids (daily dose \\> 10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of the study drug.; C. Prior vaccination with an anti-tumor vaccine or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug; D. Major surgery or significant traumatic injury within 4 weeks prior to the first dose of the study drug; E. Concurrent enrollment in another clinical study;\n13. Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires;\n14. Subjects with peripheral neuropathy ≥ Grade 2 according to CTCAE V5.0;\n15. History of allergy or hypersensitivity to any component of the study treatment;\n16. History of a primary malignancy other than head and neck squamous cell carcinoma within the previous 5 years;\n17. Requirement for concurrent treatment with other anti-tumor therapies;\n18. Patients deemed unsuitable for enrollment by the investigator;\n19. Pregnant or breastfeeding women.",{"count":116,"type":19},52,[92],"This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma.\n\nThe primary objective is the pathological complete response(pCR)rate following neoadjuvant therapy. The secondary objective includes the major pathological response(MPR)rate following neoadjuvant therapy, the objective response rate (ORR), Organ preservation rate, Surgery postponement rate, event-free survival (EFS), overall survival(OS), and safety.",[120],"Hypopharyngeal Squamous Cell Carcinoma","2026-06-18",{"date":76,"type":30},{"date":32,"type":19},{"date":125,"type":19},"2030-12-31",{"name":36,"class":37},{"id":128,"slug":4,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":62},"100613210","NCT07263620","An Exploratory Study on Microbial Biomarkers Associated With the Efficacy of Neoadjuvant Therapy","A Single-center, Exploratory Study on Predicting Neoadjuvant Therapy Efficacy and Prognosis in Pan-gastrointestinal Cancer Patients Based on Intratumoral Microbiome Characteristics and Their Functional Targets.","Inclusion Criteria:\n\n* Age ≥18 years and ≤80 years\n* Pathologically confirmed diagnosis (via preoperative biopsy) of pancreatic cancer, gastric cancer, colorectal cancer, or esophageal cancer\n* Imaging evaluation indicates borderline resectable or locally advanced disease, and the patient is scheduled to receive neoadjuvant therapy according to treatment guidelines\n* Expected survival time \\> 3 months\n* Hematologic function: neutrophil count \\> 1.5 × 10⁹\u002FL\n* Liver function:Total serum bilirubin ≤ 1.5 × upper limit of normal (ULN)；ALT and AST ≤ 2 × ULN\n* Renal function: serum creatinine ≤ 1.5 × ULN\n* No severe cardiovascular or cerebrovascular comorbidities and no psychiatric disorders\n\nExclusion Criteria:\n\n* Physically unfit to undergo neoadjuvant chemotherapy\n* Local recurrence or distant metastasis occurring within 1 month after surgery\n* Impaired vital organ function, including but not limited to: Heart failure (NYHA Class III-IV); Myocardial infarction within the past 6 months; Severe arrhythmia; Respiratory failure\n* Presence of another primary malignancy diagnosed within the past 5 years\n* Pregnant or breastfeeding\n* Inability to complete follow-up\n* Active infection\n* Severe constipation or sudden changes in bowel habits within the past 3 months\n* Significant changes in dietary habits (e.g., meat-vegetable balance, meal timing, or frequency) within the past 3 months\n* Medication history within the past 3 months including:Use of NSAIDs, immunosuppressants, antibiotics, traditional Chinese medicine, probiotics, or corticosteroids for ≥1 week; Use of proton pump inhibitors (PPIs) for more than 1 week within 1 month prior to sampling\n* Refusal to sign the informed consent form",{"count":134,"type":19},90,"Digestive system malignancies are among the most common types of cancers in China, primarily including esophageal cancer, gastric cancer, pancreatic cancer, liver cancer, and colorectal cancer. According to the 2024 National Cancer Registry data released by the National Cancer Center of China (covering a population of 523 million), digestive system tumors (including colorectal, liver, gastric, and esophageal cancers) account for 28.49% of all new cancer cases and 31.77% of total cancer-related deaths in the country. Among these, the incidence and mortality burdens of gastric, esophageal, and liver cancers are significantly higher than the global average. Most patients are diagnosed at an advanced stage, with a five-year survival rate below 30%. This highlights that digestive system malignancies represent a major public health challenge in China, necessitating in-depth studies on their pathogenesis and the development of novel prevention and treatment strategies.\n\nAt present, radical surgical resection remains the only potentially curative option for digestive system cancers. However, for patients with locally advanced or late-stage disease, surgery alone yields limited efficacy. In recent years, chemotherapy-based neoadjuvant therapy has been increasingly applied in clinical practice to improve R0 resection rates and overall survival \\[4-6\\]. Nevertheless, current studies show that the response rate to neoadjuvant therapy remains modest, and there is a lack of precise strategies for identifying therapy-sensitive patient subgroups, resulting in a limited proportion of patients who truly benefit.\n\nThe gut microbiota, as an essential component of the human microecosystem, plays a critical role in tumor initiation, progression, metastasis, and therapeutic response. Given the anatomic location of digestive system cancers, the gut microbiota-being a major source of intratumoral microorganisms-interacts closely with the tumor microenvironment. Studies have revealed marked differences in the gut microbial composition between pancreatic cancer patients and healthy individuals, characterized by a significant reduction in short-chain fatty acid (SCFA)-producing bacteria and enrichment of inflammation-associated species. Furthermore, gut-derived microbes within pancreatic tumors are closely associated with immune microenvironment remodeling and gemcitabine resistance.\n\nSimilarly, gastric cancer patients exhibit distinct microbial profiles in both gastric fluid and tumor tissue compared with healthy controls-for instance, Helicobacter pylori enrichment-which may influence both tumorigenesis and neoadjuvant treatment efficacy. In colorectal cancer, Fusobacterium nucleatum and Peptostreptococcus anaerobius are significantly enriched in tumors resistant to immunotherapy, suggesting a key role of gut microbiota in treatment resistance. In hepatocellular carcinoma, intratumoral microbial subtypes are closely linked to tumor progression, and Klebsiella pneumoniae has been shown to promote hepatocarcinogenesis.\n\nHowever, many key microbial species and their mechanistic roles in shaping the tumor microenvironment of digestive system cancers remain poorly understood, limiting the further clinical application of strategies such as neoadjuvant therapy in these patients. Therefore, a deeper investigation into the microbial characteristics of digestive system tumors and their correlation with neoadjuvant therapeutic response is of great clinical significance, particularly for identifying microbiome-based biomarkers that predict therapeutic efficacy and enable the selection of optimal candidate populations.\n\nIn summary, we have designed a prospective exploratory study to investigate the microbial characteristics and functional targets of digestive system cancers, aiming to develop and preliminarily validate a predictive model for identifying patient subgroups likely to benefit from neoadjuvant therapy. This study seeks to discover microbiome-associated biomarkers predictive of treatment efficacy and to expand the clinical application scope of neoadjuvant therapy in digestive system malignancies.",[137],"Digestive System Malignancies","2026-06-12",{"date":79,"type":30},{"date":141,"type":30},"2025-10-01",{"date":143,"type":19},"2026-08-01",{"name":36,"class":37},{"id":146,"slug":4,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":20,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":161,"leadSponsor":163,"locationsCount":62},"100620520","NCT07358689","Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer","Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist (Diphenhydramine) in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer: A Single-center, Randomized Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n* Voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits;\n* Aged 18-75 years, regardless of gender;\n* ECOG performance status score of 0-1;\n* Expected survival time ≥ 3 months;\n* \\- Pathologically\u002Fradiologically confirmed stage II-III NSCLC (AJCC 9th Edition). For adenocarcinoma\u002Fadenosquamous carcinoma, EGFR wild-type and ALK fusion-negative required before enrollment;\n* No prior systemic anti-tumor therapy;\n* At least one measurable lesion per RECIST 1.1. Previously irradiated lesions are measurable if progression is confirmed;\n* Adequate organ function, as evidenced by meeting the following laboratory parameters:\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL without administration of granulocyte colony-stimulating factor within the past 14 days;\n  2. Platelet count ≥ 80 × 10⁹\u002FL without blood transfusion within the past 14 days;\n  3. Hemoglobin \\> 8 g\u002FdL without blood transfusion or erythropoietin administration within the past 14 days;\n  4. Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN);\n  5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (for subjects with liver metastasis, AST or ALT ≤ 5 × ULN is acceptable);\n  6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin;\n  7. Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN;\n  8. Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free triiodothyronine \\[FT3\\]) and free thyroxine (FT4) within the normal range are also eligible for enrollment;\n  9. Myocardial enzyme profile within the normal range;\n* Females of childbearing potential: negative pregnancy test (urine\u002Fserum) within 3 days pre-first dose (Cycle 1 Day 1); serum test required if urine test unconfirmed. Non-childbearing females: postmenopausal ≥ 1 year, surgically sterile or hysterectomized;\n* Subjects at risk of conception: use contraception with annual failure rate \\\u003C 1% during treatment and 120-180 days post-last dose;\n\nExclusion Criteria:\n\n* Lung metastases from other primary malignancies;\n* Other systemic malignancies (excluding radically treated skin basal\u002Fsquamous cell carcinoma or resected carcinoma in situ);\n* Current or prior myasthenia gravis;\n* Current or prior angle-closure glaucoma;\n* Current or prior benign prostatic hyperplasia;\n* Diphenhydramine allergy;\n* Pyloroduodenal obstruction, peptic ulcer-induced pyloric stenosis or bladder neck stenosis;\n* Prior radiation therapy meeting any: 1) ≥ 30% bone marrow irradiated within 14 days pre-treatment; 2) Lung lesion radiation \\> 30 Gy within 6 weeks pre-treatment (must recover from radiation toxicity to Grade ≤ 1, no glucocorticoids, no radiation pneumonitis history);\n* Current participation in other interventional clinical studies, or received investigational agents\u002Fdevices within 4 weeks pre-first dose;\n* Systemic anti-lung cancer Chinese patent medicines or immunomodulators (thymosin, interferon, interleukin; excluding local pleural effusion control) within 2 weeks pre-first dose;\n* Active autoimmune diseases requiring systemic therapy (disease-modifying drugs, glucocorticoids, immunosuppressants) within 2 years pre-first dose (replacement therapy not considered systemic);\n* Ongoing systemic glucocorticoids (excluding topical) or immunosuppressants within 7 days pre-first dose (physiological doses: prednisone ≤ 10 mg\u002Fday or equivalent permitted);\n* Uncontrolled pleural\u002Fperitoneal effusion (eligible if no drainage needed or effusion stable 3 days post-drainage cessation);\n* Prior allogeneic organ transplantation (except corneal) or hematopoietic stem cell transplantation;\n* Inadequate recovery from prior intervention toxicities\u002Fcomplications (not resolved to Grade ≤ 1 or baseline, excluding fatigue\u002Falopecia);\n* Known HIV infection (HIV 1\u002F2 antibody positive);\n* Other conditions deemed unsuitable by investigator;","75 Years",{"count":153,"type":19},120,[92],"The goal of this clinical trial is to evaluate the efficacy and safety of H1 receptor antagonist (diphenhydramine) combined with toripalimab plus standard platinum-based chemotherapy in the perioperative setting in subjects with operable NSCLC.\n\nThe subjects of this study are patients with histologically or cytologically confirmed stage II-III NSCLC (AJCC Version 9) who are planned to receive neoadjuvant therapy with toripalimab combined with standard platinum-based chemotherapy. Eligible subjects were randomized at a 1:1 ratio to receive 3-4 cycles of neoadjuvant diphenhydramine (an H1 receptor antagonist) plus toripalimab and standard platinum-based chemotherapy, or toripalimab plus platinum-based chemotherapy alone, followed by treatment response evaluation and definitive surgery. After surgery, the experimental group will receive maintenance therapy with diphenhydramine (an H1 receptor antagonist) plus toripalimab for 13-14 cycles, while the control group will receive toripalimab monotherapy for the same 13-14 cycles.",[157],"NSCLC","2026-06-10",{"date":138,"type":30},{"date":27,"type":19},{"date":162,"type":19},"2029-01-01",{"name":36,"class":37},{"id":165,"slug":4,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":20,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":62},"100636037","NCT07560475","Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients","Exploratory Study of Efficacy and Safety of Different Administration Routes of SHR-A1811 in Patients With HER2-Positive Advanced Breast Cancer","Inclusion Criteria:\n\n1. Aged ≥ 18 years old.\n2. Pathologically confirmed HER2-positive advanced breast cancer. HER2 positivity is defined as IHC 3+ in \\>10% immunoreactive cells or HER2 gene amplification confirmed by in situ hybridization (ISH), which shall be verified by the pathology department of the participating center.\n3. Patients with advanced breast cancer who have received no more than 2 lines of prior systemic therapies.\n4. Expected survival time ≥ 4 months.\n5. Have at least one measurable lesion per RECIST 1.1 criteria (helical CT scan lesion diameter ≥ 10 mm with slice thickness ≤ 5 mm).\n6. Adequate major organ function without blood transfusion.\n7. Voluntarily participate in the study, sign informed consent form, with good compliance and willingness to complete follow-up visits.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-HER2 antibody-drug conjugates (ADC).\n2. Known leptomeningeal metastasis or active brain metastasis.\n3. A history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma. Malignancies cured solely by surgery more than 5 years prior to enrollment are allowed.\n4. Major surgery or severe trauma within 4 weeks before enrollment, or planned major surgery during the study period.\n5. Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment.\n6. Presence of hereditary bleeding tendency or coagulation disorders.\n7. Uncontrolled hypertension with systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg despite standard antihypertensive therapy.\n8. A history of clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, active pneumonia, pulmonary fibrosis and radiation pneumonitis (excluding asymptomatic post-radiation changes without treatment requirement).\n9. A history of severe cardiac diseases or uncontrolled cardiac conditions, including NYHA class II or higher cardiac insufficiency, unstable angina, myocardial infarction within one year, and arrhythmias requiring clinical intervention.\n10. Conditions affecting drug intake and absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.\n11. Known allergy to any component of the study drugs.\n12. Uncontrolled pleural effusion or ascites that cannot be relieved by drainage or other clinical interventions.\n13. Severe uncontrolled comorbidities, including immune deficiency disorders (e.g. HIV positivity, history of organ transplantation), active hepatitis B or hepatitis C, and severe ongoing infections requiring systemic anti-infective treatment.\n14. Any other conditions considered inappropriate for study enrollment by the investigator.",{"count":171,"type":19},60,[92],"An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer",[175,176,177],"HER2positive","Advanced Breast Cancer","HER2 + Breast Cancer","2026-06-09",{"date":180,"type":30},"2026-06-11",{"date":158,"type":19},{"date":183,"type":19},"2029-12-31",{"name":36,"class":37},{"id":186,"slug":4,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":191,"targetDuration":4,"studyType":20,"phases":193,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":62},"100643144","NCT07632118","Radiotherapy With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery","A Prospective, Multicenter, Randomized Controlled Phase III Study on Radiotherapy Combined With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery","Inclusion Criteria:\n\n* Understand and voluntarily participate in this study and sign the informed consent form\n* Age ≥18 years old and ≤75 years old, male and female.\n* Confirmed as pancreatic ductal adenocarcinoma by histopathology or cytology, with no evidence of distant metastasis confirmed by imaging.\n* The preoperative neoadjuvant chemotherapy regimen is not limited and should not exceed 4 cycles. After the operation was completed, at least one postoperative high-risk factor was present :R1\u002FR2 resection. Regional LN transfer Neurovascular invasion The pathology is poorly differentiated. Tumor height \\>4cm;\n* No disease progression was evaluated by CT or MRI after the operation.\n* The subjects have sufficient organ and bone marrow functions: absolute neutrophil count ≥1.5×109, platelet count ≥80×109, hemoglobin ≥90g\u002FL; Total bilirubin levels ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 times ULN. Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 ml\u002Fmin(Cockcroft-Gault formula);\n* ECOG PS score 0-1;\n* The expected postoperative survival period is ≥3 months;\n* Women of childbearing age who are not pregnant and have no pregnancy plans. Patients of childbearing age and their spouses are willing to take contraceptive measures that have been medically approved.\n\nExclusion Criteria:\n\n* Had received radiotherapy, palliative chemotherapy or other targeted or immunotherapy for anti-tumor treatment before pancreatic tumor resection;\n* Suffering from severe underlying diseases, including but not limited to: active infections that require systemic medication treatment; Uncontrolled diabetes and hypertension; Negligent compensatory heart failure (NYHA grades III and IV), unstable angina, and acute myocardial infarction occurred within 3 months before enrollment. Malignant peritoneal effusion or pleural effusion; Severe portal hypertension or imaging manifestations of cavernous changes in the portal vein; Gastric outlet obstruction, respiratory insufficiency (requiring oxygen inhalation) and severe lung diseases; Central nervous system diseases, mental disorders;\n* There is a history of other malignant tumors (cured basal cell carcinoma of the skin and cervical carcinoma in situ)\n* There is bleeding or coagulation disorder;\n* Postoperative complications such as bleeding, pancreatic fistula, gastric emptying disorder, abdominal infection, and biliary fistula occur, which prevent the patient from receiving adjuvant treatment within 12 weeks after the operation.\n* Those who are allergic to the drugs or their components used in this plan;\n* Known to be infected with HIV or syphilis, or currently in the active stage of hepatitis (hepatitis B, hepatitis C);\n* Female subjects who are pregnant or breastfeeding, or plan to become pregnant during the study period, or female spouses of male subjects;\n* The subjects had poor compliance and were unable to follow the various procedures, restrictions or requirements of the study, etc.\n* There are other reasons that the researcher deems unsuitable for participation in this study.",{"count":192,"type":19},288,[194],"PHASE3","Pancreatic cancer is a highly fatal malignant tumor. Simple surgical operations can no longer meet the treatment needs of pancreatic cancer patients. Postoperative adjuvant chemotherapy has a significant effect, which can effectively prevent or delay tumor recurrence and prolong the overall survival period of pancreatic cancer patients. Based on this, many guidelines both at home and abroad actively recommend that pancreatic cancer patients receive adjuvant chemotherapy after surgery (if there are no contraindications). Radiotherapy is one of the most commonly used local treatment methods. It can be used as a neoadjuvant or adjuvant therapy to increase the tumor resection rate or reduce the recurrence rate, or as a treatment approach for locally unresectable pancreatic cancer to improve local control. After complete gross resection of pancreatic cancer, the role of radioadjuvant therapy has always been controversial, and its indications for use remain unclear. However, recent clinical studies using modern radiotherapy equipment and techniques have shown that an increasing amount of data indicates that radiotherapy can benefit in the treatment of neoadjuvant, adjuvant and locally advanced pancreatic cancer. Evidence supporting adjuvant radiotherapy after pancreatectomy remains scarce. Therefore, whether screening high-risk factor populations for adjuvant radiotherapy may improve the prognosis of pancreatic cancer is an important research.",[197],"Pancreatic Cancer",[197,199,200],"radiotherapy","GX","2026-06-04",{"date":203,"type":30},"2026-06-08",{"date":205,"type":19},"2026-05-22",{"date":207,"type":19},"2031-05",{"name":36,"class":37},{"id":210,"slug":4,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":20,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":62},"100643094","NCT07634978","Development and Application of an AI Chatbot for Perioperative Health Education in Thyroid Cancer Patients","Development and Application of an Artificial Intelligence Chatbot for Perioperative Health Education Among Thyroid Cancer Patients: A Quasi-Experimental Study","Inclusion Criteria:\n\n* Diagnosed with thyroid cancer in accordance with the clinical diagnostic criteria, and confirmed by ultrasonography and histopathological examination.\n* Scheduled to undergo elective surgery for thyroid cancer.\n* Mentally competent to understand the study protocol, and voluntarily provided written informed consent to participate in this study.\n\nExclusion Criteria:\n\n* Aged less than 18 years.\n* Concurrently diagnosed with malignant tumors in other organs or severe complications\u002Fdysfunctions of other major organs.\n* Patients who are anticipated to be unable to complete the study protocol due to plans for hospital\u002Fdepartment transfer, or high risk of treatment discontinuation.","60 Years",{"count":217,"type":19},150,[22],"The goal of this clinical trial is to evaluate the usefulness and effectiveness of a newly developed artificial intelligence (AI) chatbot for health education in thyroid cancer patients during the period around their surgery (the perioperative period). The main questions it aims to answer are:\n\nDoes the AI chatbot improve patients' readiness for discharge, quality of recovery, and active engagement in their own healthcare compared to traditional education methods?\n\nHow do patients rate the usability and friendliness of this new AI chatbot system?\n\nResearchers will compare a group of patients who receive traditional health education (the control group) with a subsequent group of patients who use the new AI chatbot built on the \"Coze\" platform (the intervention group) to see if the AI chatbot leads to better recovery experiences and higher patient engagement.\n\nParticipants will be asked to:\n\nAccess and interact with the AI chatbot to receive personalized health guidance, ask questions, and get instant feedback during their hospital stay.\n\nComplete a set of questionnaires on the morning of their hospital discharge to evaluate their recovery quality, readiness to leave the hospital, and level of engagement in their care.\n\nComplete an extra survey regarding the usability and acceptability of the chatbot system (only for participants in the AI chatbot group).",[221],"Thyroid Cancer","2026-06-03",{"date":178,"type":30},{"date":225,"type":30},"2026-01-01",{"date":227,"type":19},"2026-08-31",{"name":36,"class":37},{"id":230,"slug":4,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":20,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":62},"100640187","NCT07622381","Specialist Nurse-Led Nursing Management for Patients Undergoing Head and Neck Cancer Surgery","Development and Evaluation of a Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management Model for Patients Undergoing Head and Neck Cancer Surgery: A Prospective Controlled Study","Inclusion Criteria:\n\n* Patients diagnosed with head and neck cancer according to the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Head and Neck Tumors (2023)\n* Patients scheduled to undergo head and neck cancer surgery\n* Age \\>18 years\n* Patients who fully understand the study and voluntarily agree to participate\n\nExclusion Criteria:\n\n* Patients with severe cardiovascular diseases, uncontrolled infections, or other diseases or complications that could affect study participation\n* Patients with an estimated survival time of less than 6 months based on tumor stage and overall health status","70 Years",{"count":237,"type":19},80,[22],"The goal of this clinical trial is to evaluate the effectiveness of a multidisciplinary specialist nurse-led perioperative nursing management model for patients undergoing head and neck cancer surgery. The study aims to improve perioperative recovery, reduce postoperative complications, and enhance the quality of nursing care for patients with head and neck cancer.\n\nThe main questions it aims to answer are:\n\nDoes the multidisciplinary specialist nurse-led nursing management model reduce the incidence of postoperative complications in patients undergoing head and neck cancer surgery? Does the intervention improve nutritional indicators, quality of life, and nursing satisfaction compared with routine perioperative nursing care? Does the intervention reduce length of hospital stay and hospitalization costs?\n\nResearchers will compare patients receiving the multidisciplinary specialist nurse-led perioperative nursing management model with patients receiving routine perioperative nursing care to evaluate the effectiveness of the intervention.\n\nParticipants will:\n\nReceive either routine perioperative nursing care or the multidisciplinary specialist nurse-led nursing management intervention during hospitalization Undergo comprehensive perioperative assessments, including nutritional status, risk of pulmonary complications, swallowing function, voice function, oral health status, and psychological condition Receive individualized multidisciplinary rehabilitation and nursing interventions developed collaboratively by specialist nurses, physicians, dietitians, and psychological counselors Participate in perioperative rehabilitation, health education, and continuous follow-up management during hospitalization Complete assessments of quality of life and nursing satisfaction during the perioperative period",[241],"Head & Neck Cancer","2026-06-02",{"date":222,"type":30},{"date":245,"type":30},"2025-11-24",{"date":247,"type":19},"2026-09-30",{"name":36,"class":37},{"id":250,"slug":4,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":20,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":266,"locationsCount":62},"100617454","NCT07318831","Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory\u002FRelapsed Neuroblastoma in Children","A Phase II Trial of Chidamide Combined With Dinutuximab Beta, Irinotecan, and Temozolomide for Refractory or Relapsed Neuroblastoma in Children","Inclusion Criteria:\n\n1. Patients with histologically diagnosed neuroblastoma, defined according to the International Neuroblastoma Risk Group (INRG) classification system or the Chinese expert consensus\u002Fguideline for pediatric neuroblastoma.\n2. Patients with relapsed or refractory neuroblastoma. Relapsed: any patient with recurrent neuroblastoma. Refractory: patients showing an inadequate response (partial response, minor response, or stable disease) to prior therapy, leading to progression.\n3. Prior treatment with epigenetic drugs (e.g., HDAC inhibitors, DNA methylation inhibitors) or GD2 monoclonal antibodies does not affect eligibility for this study.\n4. Presence of evaluable disease.\n5. Performance Status: Lansky score ≥50%, Karnofsky score ≥50%, or ECOG score ≤3.\n6. Life expectancy ≥12 weeks.\n7. Bone marrow function: Without bone marrow disease: Platelets ≥75×10⁹\u002FL, Absolute Neutrophil Count (ANC) ≥0.75×10⁹\u002FL, Hemoglobin ≥8 g\u002FdL (transfusion allowed). With bone marrow disease: Platelets ≥50×10⁹\u002FL, ANC ≥0.5×10⁹\u002FL, Hemoglobin ≥8 g\u002FdL (transfusion allowed).\n8. Renal function: No clinically significant proteinuria (morning urine dipstick \\\u003C2+). If proteinuria ≥2+ is detected, the protein-to-creatinine (Pr\u002FCr) ratio must be \\\u003C0.5 or 24-hour protein excretion must be \\\u003C0.5 g.\n9. Serum creatinine ≤1.5 × ULN; if higher, the calculated glomerular filtration rate (by radioisotope method) must be ≥60 mL\u002Fmin\u002F1.73 m².\n10. Hepatic function: AST or ALT ≤2.5 × ULN and total bilirubin ≤1.5 × ULN. In the presence of liver metastases: AST or ALT ≤5 × ULN and total bilirubin ≤2.5 × ULN.\n11. Cardiac function: Left ventricular shortening fraction ≥29% on echocardiogram.\n12. Coagulation: For patients not on anticoagulation therapy: INR ≤1.5 and APTT ≤1.5 × ULN. Anticoagulation is allowed if INR or APTT is within the therapeutic range (per institutional standards) and the patient has been on a stable dose for at least two weeks prior to study enrollment.\n13. Oxygen saturation \\>94% on room air.\n14. Ability to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Patients with CTCAE v5.0 Grade 3 or higher toxicities involving hearing impairment, hematologic disorders, hepatic, or renal diseases.\n2. Patients with CTCAE v5.0 Grade 2 or higher neurotoxicity.\n3. Major surgical procedure within 14 days prior to the first dose of the study drug.\n4. Severe infection (requiring IV antibiotics, antifungals, or antivirals) within one week prior to treatment, or unexplained fever \\>38.5°C during screening or before the first dose.\n5. Congenital or acquired immunodeficiency, or active infectious diseases such as HIV or active hepatitis (with transaminase levels not meeting inclusion criteria; HBV DNA ≥1000 IU\u002FmL; HCV RNA ≥1000 IU\u002FmL). Chronic HBV carriers with HBV DNA \\\u003C2000 IU\u002FmL may be enrolled if they receive concurrent antiviral therapy during the trial.\n6. Any concomitant condition that, in the investigator's judgment, seriously jeopardizes patient safety, may confound the study results, or could impede the patient's completion of the study.",{"count":256,"type":19},27,[92],"This is a Phase II clinical trial investigating the effectiveness and safety of a four-drug combination-Chidamide, Dinutuximab Beta, Irinotecan, and Temozolomide-for children with relapsed or refractory neuroblastoma. The primary goal is to evaluate how well this regimen works to control the cancer, while the secondary goal is to closely monitor its safety and side effects in these young patients.",[260,261],"Neuroblastoma (NB)","Neuroblastoma in Children",{"date":201,"type":30},{"date":264,"type":30},"2026-01-06",{"date":34,"type":19},{"name":36,"class":37},{"id":268,"slug":4,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":274,"targetDuration":4,"studyType":20,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":283,"leadSponsor":284,"locationsCount":285},"100639579","NCT07627464","Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy","A Multicenter, Randomized Controlled Phase II Study of Neoadjuvant Anlotinib Hydrochloride Capsules Combined With Benmelstobart Injection Versus Surgery Alone for Localized Renal Cell Carcinoma Planned for Partial Nephrectomy","ALTER-UC-011","Inclusion Criteria:\n\n1. Aged between 18 and 75 years, inclusive.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.\n4. Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n5. No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.\n\nExclusion Criteria:\n\n1. Subjects with a solitary kidney tumor.\n2. Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).\n3. Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau \\[VHL\\] disease).\n4. Subjects with a prior history of renal transplantation.",{"count":275,"type":19},144,[92],"Evaluation of long-term renal function improvement, surgical safety, as well as efficacy and safety of preoperative anlotinib hydrochloride capsules combined with benmelstobart injection versus surgery in patients with localized renal cell carcinoma undergoing partial nephrectomy",[279],"Renal Cell Carcinoma (RCC)","2026-05-31",{"date":201,"type":30},{"date":280,"type":19},{"date":183,"type":19},{"name":36,"class":37},14,{"id":287,"slug":4,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":292,"targetDuration":4,"studyType":20,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":62},"100614558","NCT07281157","Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer","Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined With Short-Course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-Center, Single-Arm Study","Inclusion Criteria:\n\n1. Age of 18-75 years old;\n2. rectal adenocarcinoma confirmed by histology and\u002For cytology;\n3. locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC\u002FUICC TNM staging (8th edition, 2017);\n4. Distance from lower margin to anal margin ≤ 10 cm;\n5. Patients with at least one assessable lesion according to RECIST1.1 criteria;\n6. ECOG 0-1;\n7. the expected survival time was more than 12 months;\n8. had not received anti-tumor treatment for rectal cancer after diagnosis, including radiotherapy, chemotherapy, surgery, etc.\n9. Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, hemoglobin ≥90g\u002FdL, platelet (PLT) ≥100×10\\^9\u002FL, white blood cell (WBC) ≥3.0×10\\^9\u002FL;\n10. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), if there is liver metastasis ≤5×ULN, total bilirubin \\\u003C1.5 ULN;\n11. Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL\u002Fmin (according to Cockcroft-Gault formula);\n12. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN;\n13. exclude active or suspected infection;\n14. non-pregnant or lactating women; Women\u002Fmen of childbearing age should use effective contraception during the study and for 6 months after the end of study treatment;\n15. The patients had good compliance, understood the research process of this study, and signed the written informed consent.\n\nExclusion Criteria:\n\n1. patients with other malignant tumors (except cured carcinoma in situ and basal cell carcinoma) in the past 5 years;\n2. patients with mismatch repair deficiency (dMMR) or microsatellite instability high (MSI-H);\n3. obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding \\> 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood \\> 5 mL within 4 weeks), etc. Or treatment for a venous\u002Fvenous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg\u002F day or clopidogrel ≥75 mg\u002F day) may be required.\n4. extensive distant metastasis (e.g., peritoneal metastasis, multiple bone\u002Fbrain metastases);\n5. patients who had used potent CYP3A4 inducers at the same time within 3 weeks before the first dose, or had used potent CYP3A4 inhibitors or potent UGT1A1 inhibitors within 3 weeks before the first dose;\n6. patients who underwent major organ surgery (excluding needle biopsy, central venous catheterization, port catheterization, stent placement to relieve biliary obstruction, percutaneous hepatobiliary drainage, cholecystostomy) or elective surgery within 4 weeks before treatment;\n7. tumor invasion of large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, and there is a high risk of bleeding according to the investigator's judgment;\n8. Active heart disease (including myocardial infarction, severe\u002Funstable angina) within 6 months before treatment. Echocardiography showed that the left ventricular ejection fraction was less than 50% and the arrhythmia was not well controlled.\n9. have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg);\n10. subjects with active infection or fever of unknown origin \\>38.5 degrees during screening or before the first dose of medication (according to the investigator's assessment, subjects with fever due to cancer could be enrolled);\n11. subjects with congenital or acquired immunodeficiency, such as HIV infection or active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000 IU\u002Fml; hepatitis C reference: HCV RNA≥1000 IU\u002Fml); Chronic hepatitis B virus carriers, HBV DNA \\\u003C 2000 IU\u002Fml, must receive antiviral therapy at the same time during the trial.\n12. any other medical condition, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality where there is reason to suspect that the patient has a disease or condition (such as having seizures requiring treatment) that would be inappropriate for the study drug, in the investigator's judgment, or that would affect interpretation of the study results or place the patient at high risk;\n13. intestinal obstruction (except incomplete intestinal obstruction requiring only enteral nutrition); Subjects at risk of intestinal perforation (including, but not limited to, a history of acute diverticulitis, abdominal abscess, or abdominal cancer); (14 ) History of wide bowel resection (partial colectomy or wide small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n\n(15) Has received any other antibodies\u002Fdrugs (including PD-1, PD-L1, PD-L2, CTLA-4, OX40, CD137 inhibitors, etc.) acting on T cell co-stimulation or checkpoint pathway.\n\n(16) patients with CTCAE 5.0 grade ≥ 3 immune-related adverse events (AE) after immunotherapy.\n\n(17) patients receiving glucocorticoid (prednisone \\>10mg\u002F day or equivalent dose of other drugs of the same kind) or other immunosuppressive therapy for some condition within 14 days before the first dose of the drug.\n\n(18) participated in other clinical investigators within 4 weeks before enrollment; (19) a documented history of allergy to study drugs, including Enlonstobart, capecitabine, liposomal irinotecan, and any component of the drug; (20) pregnant or lactating female subjects; Patients deemed by the investigator to be ineligible for trial participation.",{"count":90,"type":19},[92],"This is a prospective, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.",[296],"Advanced Rectal Cancer",{"date":222,"type":30},{"date":299,"type":30},"2025-11-01",{"date":301,"type":19},"2032-04-30",{"name":36,"class":37},{"id":304,"slug":4,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":309,"targetDuration":4,"studyType":20,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":62},"100605437","NCT07162506","DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR\u002FPR After nCI","Definitive Concurrent Chemoradiotherapy Versus Surgery in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (ESCC) Who Achieve Complete or Partial Response After Neoadjuvant Chemo-immunotherapy: A Two-arm Phase II Clinical Study (SORT Trial)","Inclusion Criteria:\n\n1. Volunteered to participate, cooperated with follow-up visits.\n2. Aged 18 - 75 years (inclusive), male or female.\n3. Histologically confirmed locally advanced resectable ESCC, clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC), and achieve cCR\u002FPR after 2-3 cycles of platinum-based chemotherapy combined with anti-PD-1 or PD-L1 monoclonal antibodies.\n4. Presence of measurable and\u002For non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n6. Estimated survival time ≥ 3 months.\n7. The function of major organs meets the following requirements:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL;\n   2. Platelets ≥ 80×10\\^9\u002FL;\n   3. Hemoglobin ≥ 9g\u002FdL;\n   4. Serum albumin ≥ 2.8g\u002FdL;\n   5. Total bilirubin ≤ 1.5 × ULN, ALT, AST and\u002For ALP ≤ 2.5 × ULN;\n   6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL\u002Fmin;\n   7. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (subjects on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and with INR within the expected therapeutic range of the anticoagulant can be screened);\n8. Comprehensive baseline staging evaluation prior to induction chemo-immunotherapy, including esophagogastroduodenoscopy (with biopsy) and\u002For endoscopic ultrasonography (EUS), contrast-enhanced CT of the neck, chest, and upper abdomen (with or without PET-CT), magnetic resonance imaging (MRI) without MRI contraindications, and upper gastrointestinal contrast.\n9. Patients of childbearing potential must use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment period and within 6 months after the end of the study treatment; serum Human Chorionic Gonadotropin (HCG) or urine HCG test must be negative within 72 hours before study enrollment; and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Surgery for esophageal cancer;\n2. Esophageal fistulae due to infiltration of the primary tumor；\n3. Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;\n4. Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;\n5. Major surgery or severe trauma within 4 weeks prior to first use of study drug;\n6. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;\n7. Received or receiving any of the following treatments in the past:\n\n   1. Radiotherapy or targeted therapy;\n   2. Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;\n   3. Systemic treatment with corticosteroids (\\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment (except for the use of corticosteroids for local inflammation of the esophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor. Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \\>10mg\u002Fday prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;\n   4. Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;\n8. Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;\n9. Diagnosis of immunodeficiency, including positive HIV test, other acquired\u002Fcongenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;\n10. Diagnosis of uncontrolled cardiac clinical symptoms or disease such as: a. NYHA II or above heart failure; b. unstable angina; c. myocardial infarction within 1 year; d. clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n11. Severe infections (CTCAE \\> grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;\n12. History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;\n13. Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;\n14. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);\n15. Presence of abnormal sodium, potassium, and calcium laboratory test values greater than grade 1 within 2 weeks prior to enrollment that do not improve with treatment;\n16. Known hypersensitivity to large protein preparations, or to any of the components of camrelizumab, or anaphylaxis, hypersensitivity, or contraindication to paclitaxel or carboplatin or to any of the components used within their preparations;\n17. Previously diagnosed with any other malignancy within 5 years before the first use of the investigational drug, except for malignancies with low risk of metastasis and death (5-year survival rate\\>90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.\n18. As judged by the investigator, the subject has other factors that may lead to forced termination of the study midway.",{"count":153,"type":19},[92],"This is a multi-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response\u002Fpartial response (cCR\u002FPR) after neoadjuvant chemo-immunotherapy.\n\nA total of 120 eligible subjects will be enrolled. Patients with cCR\u002FPR after 2-3 cycles of neoadjuvant chemo-immunotherapy will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy\u002F28f; chemotherapy: nab-paclitaxel 175mg\u002Fm² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.",[313],"Esophageal Cancer","2026-05-26",{"date":316,"type":30},"2026-05-29",{"date":318,"type":30},"2025-11-03",{"date":320,"type":19},"2030-08-30",{"name":36,"class":37},{"id":323,"slug":4,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":20,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":62},"100638748","NCT07609641","Surgical Total Clearance Versus Extrahepatic Bile Duct Preservation for Biliary Tract Malignancies: A Single-Center, Randomized, Two-Arm, Prospective Phase II Clinical Trial","Inclusion Criteria:\n\n* Age 18 years or older, regardless of gender.\n\nVoluntary participation with full informed consent; signed written informed consent form; good compliance.\n\nHistologically or cytologically confirmed cholangiocarcinoma (CCA).\n\nGallbladder cancer or intrahepatic cholangiocarcinoma with preoperative lymph node metastasis.\n\nNo prior systemic chemotherapy, immunotherapy, targeted therapy, or local treatment for CCA (including but not limited to transarterial chemoembolization, arterial embolization, arterial infusion chemotherapy, and radioactive particle embolization).\n\nAt least one measurable lesion according to RECIST v1.1.\n\nChild-Pugh class A liver function, and no history of hepatic encephalopathy.\n\nEastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.\n\nLife expectancy ≥ 12 weeks.\n\nAdequate organ function meeting the following requirements (no blood transfusion, blood products, hematopoietic growth factors, or other medications to correct blood counts within 14 days prior to randomization):\n\nWhite blood cell count ≥ 4.0 × 10⁹\u002FL;\n\nAbsolute neutrophil count ≥ 1.5 × 10⁹\u002FL;\n\nPlatelet count ≥ 90 × 10⁹\u002FL;\n\nHemoglobin ≥ 90 g\u002FL;\n\nSerum albumin ≥ 30 g\u002FL;\n\nSerum total bilirubin ≤ 2 × upper limit of normal (ULN); any biliary obstruction must be resolved before randomization;\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n\nCreatinine clearance (CrCl) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n\nInternational normalized ratio (INR) ≤ 2 and prothrombin time (PT) prolonged ≤ 3 seconds above the ULN.\n\nFor active hepatitis B, effective antiviral therapy (per local standard of care, e.g., entecavir or tenofovir) is required, with HBV DNA \\\u003C 2000 IU\u002FmL or a ≥ 10-fold decrease in HBV DNA after antiviral treatment; patients must agree to continue effective anti-HBV therapy throughout the study period.\n\nWithin 7 days prior to randomization, women of childbearing potential must have a negative serum pregnancy test and agree to use effective contraception during the study treatment period and for 6 months after the last dose. In this protocol, a woman of childbearing potential is defined as a sexually mature woman who: 1) has not undergone hysterectomy or bilateral oophorectomy; 2) has not been naturally postmenopausal for at least 24 consecutive months (amenorrhea following cancer therapy does not rule out fertility) (i.e., has had menses at any time in the preceding 24 consecutive months). Male patients with female partners of childbearing potential must agree to use effective contraception during the study treatment period and for 5 months after the last dose.\n\nExclusion Criteria:\n\n* Histopathologically or cytologically confirmed hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.\n\nOther malignancy within 5 years, except for cured localized tumors, including non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma.\n\nRadiotherapy for CCA within 4 weeks prior to randomization; major surgery (excluding diagnostic biopsy) within 4 weeks prior to randomization.\n\nHistory of severe cardiovascular or cerebrovascular disease:\n\nNew York Heart Association (NYHA) class II or greater congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident within 12 months prior to randomization;\n\nLeft ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography;\n\nCorrected QT interval (QTc) \\> 480 ms (calculated using the Fridericia method; if QTc is abnormal, it may be measured three times consecutively at 2-minute intervals, and the average taken);\n\nPoorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg, based on the average of ≥ 2 readings);\n\nPrior hypertensive crisis or hypertensive encephalopathy.\n\nEvidence of significant bleeding\u002Fcoagulation disorder or bleeding tendency:\n\nClinically significant hemoptysis or tumor bleeding of any cause within 4 weeks prior to randomization;\n\nPrior tumor rupture (unless surgically treated);\n\nThrombotic or embolic event within 6 months prior to randomization;\n\nTherapeutic anticoagulation within 2 weeks prior to randomization (except for low-molecular-weight heparin);\n\nNeed for antiplatelet therapy;\n\nUse of aspirin (\\> 325 mg\u002Fday), clopidogrel (\\> 75 mg\u002Fday), dipyridamole, ticlopidine, or cilostazol within 10 days prior to randomization.\n\nKnown central nervous system metastasis and\u002For meningeal metastasis (including dural and leptomeningeal metastasis).\n\nAny other condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.","80 Years",{"count":171,"type":19},[22],"When lymph node dissection of stations 12 and 13 is performed, resecting the bile duct from the superior portion of the pancreas to the confluence of the right and left hepatic ducts allows complete removal of the station 12 and 13 lymph nodes. Preserving the bile duct from the superior pancreas to the hepatic confluence, however, makes a skeletonizing dissection of the duct impossible in order to safeguard the biliary blood supply, inevitably leaving behind a small amount of periductal lymphoid tissue. This results in incomplete lymph node clearance, which may increase the risk of postoperative recurrence and reduce the R0 resection rate.\n\nThis study aims to investigate the lymph node dissection approach for surgically resected cholangiocarcinoma following induction therapy, to establish criteria for evaluating surgical indications, and to provide a basis for surgical treatment strategies in patients with cholangiocarcinoma.",[332],"BTC",[332],"2026-05-20",{"date":336,"type":30},"2026-05-27",{"date":338,"type":30},"2025-10-20",{"date":340,"type":19},"2027-12-31",{"name":36,"class":37},{"id":343,"slug":4,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":15,"minAge":235,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":20,"phases":350,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":62},"100595913","NCT07038629","Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC","Concurrent Chemoradiation Plus Iparomlimab Consolidation Therapy for Older Patients With Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-arm Phase II Clinical Study","Inclusion Criteria:\n\n1. Volunteered to participate, cooperated with follow-up visits;\n2. Aged ≥ 70 years, both male and female;\n3. Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC );\n4. Presence of measurable and\u002For non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);\n5. Initial treatment: definitive concurrent chemoradiotherapy (radiotherapy: total dose 50.4 Gy, delivered in 28 fractions, 1.8 Gy per fraction, 5 times per week; chemotherapy: S-1: 40-60mg, BID, d1-14, d22-35, for a total of 2 cycles).\n\n   1. Radiotherapy: completed ≥ 25 fractions or more (i.e., radiotherapy dose ≥ 45 Gy), S-1chemotherapy: completed at least one cycle (d1-14);\n   2. Haven't received any previous systemic anti-tumor therapy before radiotherapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational treatment drugs);\n6. ECOG performance status 0 or 1;\n7. Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \\[FFPE\\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;\n8. Expected survival of ≥ 3 months.\n9. The function of major organs meets the following requirements:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL;\n   2. Platelets ≥ 100×10\\^9\u002FL;\n   3. Hemoglobin ≥ 9g\u002FdL;\n   4. Serum albumin ≥ 2.8g\u002FdL;\n   5. Total bilirubin ≤ 1.5 × ULN, ALT, AST and\u002For ALP ≤ 2.5 × ULN;\n   6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL\u002Fmin;\n   7. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (subjects on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and with INR within the expected therapeutic range of the anticoagulant can be screened);\n10. Documented informed consent.\n\nExclusion Criteria:\n\n1. Surgery for esophageal cancer;\n2. Esophageal fistulae due to infiltration of the primary tumor；\n3. Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;\n4. Patients who developed ≥ grade 2 pneumonia after concurrent chemoradiotherapy with S-1;\n5. Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;\n6. Major surgery or severe trauma within 4 weeks prior to first use of study drug;\n7. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;\n8. Received or receiving any of the following treatments in the past:\n\n   1. Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;\n   2. Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;\n   3. Systemic treatment with corticosteroids (\\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment(except for the use of corticosteroids for local inflammation of the esophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor. Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \\>10mg\u002Fday prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;\n   4. Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;\n9. Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;\n10. Diagnosis of immunodeficiency, including positive HIV test, other acquired\u002Fcongenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;\n11. Diagnosis of uncontrolled cardiac clinical symptoms or disease such as: a. NYHA II or above heart failure; b. unstable angina; c. myocardial infarction within 1 year; d. clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n12. Severe infections (CTCAE \\> grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;\n13. History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;\n14. Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;\n15. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);\n16. Presence of abnormal sodium, potassium, and calcium laboratory test values greater than grade 1 within 2 weeks prior to randomisation that do not improve with treatment;\n17. Known hypersensitivity to large protein preparations, or to any of the components of tirilizumab, or anaphylaxis, hypersensitivity, or contraindication to paclitaxel or cisplatin or to any of the components used within their preparations;\n18. Previously diagnosed with any other malignancy before the first use of the investigational drug, except for malignancies with low risk of metastasis and death (5-year survival rate\\>90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.\n19. As judged by the investigator, the subject has other factors that may lead to forced termination of the study midway.","90 Years",{"count":116,"type":19},[92],"This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma (ESCC). Aim to evaluate the efficacy and safety of Iparomlimab consolidation therapy following concurrent chemoradiation with S-1 in elderly patients with unresectable locally advanced ESCC.\n\nConcurrent chemoradiation is the standard treatment for elderly esophageal cancer. However, the overall prognosis of patients still needs to be further improved. The emergence of immune checkpoint inhibitors has brought new hope for patients with ESCC. Iparomlimab can target both PD-1 and CTLA-4 immune inhibitory pathways simultaneously. Studies have shown that it can significantly improve the prognosis in the treatment of ESCC and has good tolerability. In elderly patients with ESCC, concurrent chemoradiation may potentially carry the risk of low treatment completion rate and significant toxicity. Therefore, this study aims to explore the efficacy and safety of Iparomlimab consolidation therapy following concurrent chemoradiotherapy in elderly patients with unresectable locally advanced ESCC.\n\nIn the study, the investigators plan to enroll 52 elderly subjects with locally advanced ESCC. After receiving radiotherapy combined with the S-1 regimen, patients will enter the screening period. The enrolled patients will receive Iparomlimab consolidation therapy for 1 year. The treatment efficacy and safety will be evaluated.",[313],[354,313,355,356],"Old Age","Iparomlimab","Chemoradiation","2026-05-18",{"date":334,"type":30},{"date":360,"type":30},"2025-09-08",{"date":362,"type":19},"2027-09-30",{"name":36,"class":37},{"id":365,"slug":4,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":369,"targetDuration":4,"studyType":20,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":62},"100638074","NCT07594925","Short-Course Radiotherapy Followed by Immunotherapy Combined With Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer: A Prospective, Randomized, Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n1. Age 18-75 years, regardless of gender;\n2. Stage II\u002FIII disease (cT3-T4N0 or cT2-4N+) without distant metastasis on magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS), according to the 8th edition of the AJCC Cancer Staging Manual (2018);\n3. The lower boundary of the lesion is ≤ 10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;\n4. Pathologically confirmed or re-reviewed rectal adenocarcinoma;\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n6. Meet the following laboratory diagnostic indicators:\n\n   Hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.5×10⁹\u002FL;\n7. Neutrophil count ≥ 1.5×10⁹\u002FL, platelet count ≥ 100×10⁹\u002FL;\n8. Creatinine ≤ 1.0×upper normal limit (UNL), blood urea nitrogen (BUN) ≤ 1.0×UNL;\n9. Alanine aminotransferase (ALT) ≤ 1.5×UNL;\n10. Aspartate aminotransferase (AST) ≤ 1.5×UNL;\n11. Alkaline phosphatase (ALP) ≤ 1.5×UNL;\n12. Total bilirubin (TBIL) ≤ 1.5×UNL;\n13. Urinary protein (-); normal bleeding and coagulation time.\n14. No history of allergy to platinum-based drugs;\n15. For patients with primary rectal cancer, no surgery (except palliative colostomy), chemotherapy, or other anti-tumor treatments have been performed from diagnosis to enrollment;\n16. No previous radiation therapy to the intended radiation field;\n17. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Previous treatment with anti-PD-1\u002FL1, anti-CTLA-4 immunotherapeutic drugs, or other experimental immunotherapeutic agents;\n2. Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;\n3. Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonia;\n4. Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;\n5. History of other malignant tumors, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix;\n6. Patients with active infection, heart failure, myocardial infarction within 6 months, unstable angina pectoris, or unstable arrhythmia;\n7. Physical examination or clinical laboratory findings that the investigator believes may interfere with the results or increase the risk of treatment complications in patients, or other uncontrollable diseases;\n8. Lactating or pregnant women;\n9. Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation;\n10. Known active hepatitis B virus (HBV) infection (HBV-DNA ≥ 2000 U\u002FmL), hepatitis C virus (HCV) infection, or active pulmonary tuberculosis infection;\n11. Patients who have received tumor vaccines or other vaccines within 4 weeks before the start of treatment; (Note: Seasonal influenza vaccines for injection are mostly inactivated vaccines and thus allowed, while intranasal preparations are usually live attenuated vaccines and thus not allowed);\n12. Patients receiving concurrent use of other immunomodulators, chemotherapeutic drugs, drugs in other clinical studies, or long-term cortisol therapy are not eligible for enrollment;\n13. Patients with mental illness, substance abuse, or social problems that affect compliance will not be enrolled after review by doctors;\n14. Patients with allergies or contraindications to the study drugs.",{"count":370,"type":19},130,[92],"Microsatellite stable (MSS) locally advanced rectal cancer (LARC) remains a major therapeutic challenge despite advances in multimodal treatment. Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer-related death. In China, rectal cancer accounts for nearly half of all colorectal cancers, with approximately 70% of patients presenting with locally advanced disease, which is associated with a high risk of recurrence and poor long-term survival.\n\nNeoadjuvant chemoradiotherapy followed by total mesorectal excision (TME) has become the standard treatment for LARC based on landmark trials such as CAO\u002FARO\u002FAIO-94, NSABP-R03, and MRC-CR07, which demonstrated improved local control and reduced recurrence. However, the optimal neoadjuvant strategy remains under active investigation.\n\nCurrently, long-course chemoradiotherapy and short-course radiotherapy (SCRT) are the two principal preoperative radiotherapy approaches. Long-course chemoradiotherapy achieves superior tumor downstaging and pathological complete response (pCR) rates but requires prolonged treatment duration and is associated with greater acute toxicity. In contrast, SCRT offers shorter treatment time, lower cost, and reduced toxicity. Importantly, delayed surgery after SCRT can significantly enhance tumor regression and achieve pCR rates comparable to those of long-course chemoradiotherapy.\n\nThe development of total neoadjuvant therapy (TNT) has further transformed rectal cancer management by moving systemic chemotherapy to the preoperative setting, thereby improving treatment compliance, tumor response, and organ preservation. Among TNT strategies, consolidation chemotherapy after radiotherapy appears to provide superior tumor regression compared with induction chemotherapy.\n\nImmune checkpoint inhibitors targeting the PD-1\u002FPD-L1 pathway have demonstrated remarkable efficacy in mismatch repair-deficient (dMMR)\u002Fmicrosatellite instability-high (MSI-H) rectal cancer. However, the majority of rectal cancers are mismatch repair-proficient\u002Fmicrosatellite stable (pMMR\u002FMSS) tumors, which are generally considered immunologically \"cold\" and poorly responsive to immunotherapy alone.\n\nRadiotherapy can enhance antitumor immunity through increased antigen presentation, dendritic cell activation, CD8+ T-cell infiltration, and stimulation of systemic immune responses. Preclinical and clinical studies suggest synergistic effects between radiotherapy and immune checkpoint blockade. Several prospective studies combining chemoradiotherapy, chemotherapy, and immunotherapy in MSS LARC have reported encouraging pCR rates, particularly when immunotherapy is administered during the consolidation phase.\n\nSCRT-based TNT combined with immunotherapy has shown especially promising efficacy, with pCR rates exceeding those achieved with conventional chemoradiotherapy. Nevertheless, whether improved tumor regression can translate into durable survival benefits remains unclear. In this context, postoperative immunotherapy maintenance may represent an important strategy to further improve long-term disease control.\n\nSintilimab is a fully human anti-PD-1 monoclonal antibody that restores T-cell-mediated antitumor immunity by blocking the PD-1\u002FPD-L1 pathway. Previous studies have demonstrated favorable pharmacokinetics, durable receptor occupancy, and manageable toxicity profiles.\n\nBased on this rationale, we designed a prospective randomized phase II study to evaluate the efficacy and safety of SCRT sequentially combined with sintilimab and XELOX chemotherapy in MSS LARC. Patients in the experimental arm will receive SCRT followed by four cycles of XELOX plus sintilimab before TME surgery, followed by postoperative XELOX plus sintilimab and one year of immunotherapy maintenance. Patients in the control arm will receive SCRT combined with XELOX chemotherapy without maintenance immunotherapy.\n\nThe primary endpoint is 3-year disease-free survival (3y-DFS). Secondary endpoints include pCR, objective response rate (ORR), overall survival (OS), 3-year OS rate, and treatment safety. This study aims to determine whether the addition of sintilimab and postoperative immunotherapy maintenance can improve long-term survival while maintaining acceptable safety. Through integration of radiotherapy, chemotherapy, and immunotherapy, this study seeks to establish a more effective TNT-based strategy for MSS rectal cancer.",[374],"Rectal Cancer",[376,377,199,378],"rectal cancer","Immunotherapy","chenmotherapy","2026-05-17",{"date":381,"type":30},"2026-05-19",{"date":383,"type":19},"2026-05-01",{"date":385,"type":19},"2030-03-01",{"name":36,"class":37},{"id":388,"slug":4,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":69,"minAge":16,"maxAge":151,"enrollmentInfo":393,"targetDuration":4,"studyType":20,"phases":394,"briefSummary":395,"conditions":396,"keywords":401,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":4},"100638290","NCT07591831","Liposomal Irinotecan Plus Enlonstobart for Platinum-Resistant Recurrent Ovarian Cancer","An Exploratory Clinical Study of Liposomal Irinotecan Combined With Enlonstobart in Patients With Platinum-Resistant Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Female participants aged 18 to 75 years, inclusive, at the time of signing informed consent.\n2. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV.\n3. Platinum-resistant recurrent disease, defined as disease progression within 6 months after the last platinum-containing chemotherapy, and not platinum-refractory disease, defined as disease progression within 4 weeks after initial platinum-containing chemotherapy. Participants may have received up to two prior lines of non-platinum systemic therapy. Treatment with a PARP inhibitor or anti-angiogenic therapy after platinum-resistant recurrence will be counted as one line of therapy; maintenance treatment with a PARP inhibitor or anti-angiogenic therapy will not be counted as a treatment line.\n4. Ability to provide sufficient qualified formalin-fixed paraffin-embedded tumor tissue samples or slides for PD-L1 testing. Participants who are unable to provide tumor tissue slides for certain reasons may be enrolled at the investigator's discretion.\n5. At least one measurable lesion at baseline according to RECIST version 1.1. The measurable lesion must not have received prior local therapy such as radiotherapy. A lesion located within a previously irradiated area may be selected as a target lesion if disease progression has been confirmed.\n6. ECOG performance status of 0 or 1.\n7. Expected survival of at least 3 months.\n8. Adequate organ function, meeting all of the following criteria without blood transfusion, hematopoietic stimulating factors, or medication correction of blood cell counts within 14 days before the first dose:\n\n   1. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL;\n   2. Platelet count ≥75 × 10\\^9\u002FL;\n   3. Hemoglobin ≥9 g\u002FdL;\n   4. Serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥50 mL\u002Fmin;\n   5. Total bilirubin ≤1.5 × the upper limit of normal, or ≤3 × the upper limit of normal for participants with Gilbert's syndrome;\n   6. Alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal, or ≤5 × the upper limit of normal for participants with liver metastases;\n   7. Activated partial thromboplastin time and international normalized ratio ≤1.5 × the upper limit of normal, without anticoagulants or other drugs affecting coagulation function within 14 days before the first dose, except for participants requiring long-term anticoagulation due to underlying disease.\n9. Toxicities caused by prior antitumor therapy must have recovered to Grade 1 or lower according to CTCAE version 5.0, except for residual alopecia and fatigue.\n10. Participants must understand the study and voluntarily sign written informed consent before study entry.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity reaction to monoclonal antibody preparations or uncontrolled allergic asthma.\n2. Known untreated central nervous system metastases, or treated but still symptomatic central nervous system metastases. Participants with residual signs or symptoms related to central nervous system treatment may be eligible if neurological symptoms have been stable or improved for at least 2 weeks before screening.\n3. History of primary immunodeficiency.\n4. Active autoimmune disease or history of autoimmune disease. Participants with well-controlled type 1 diabetes mellitus, well-controlled hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment such as vitiligo, psoriasis, or alopecia, or conditions not expected to recur without external triggers may be eligible for further screening.\n5. Serious arterial or venous thrombotic events within 3 months before screening, such as transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep venous thrombosis, or pulmonary embolism.\n6. History of interstitial lung disease, except localized radiation-induced interstitial pneumonia, or noninfectious pneumonia requiring glucocorticoid therapy.\n7. Prior treatment with any antibody or drug targeting T-cell costimulatory or immune checkpoint pathways, including PD-1, PD-L1, PD-L2, CTLA-4, OX40, or CD137 inhibitors.\n8. Prior immune-related adverse event of CTCAE version 5.0 Grade 3 or higher after immunotherapy.\n9. Major surgery or radical radiotherapy within 28 days before the first dose; palliative radiotherapy within 14 days before the first dose; or use of radiopharmaceuticals such as strontium or samarium within 56 days before the first dose.\n10. Systemic antitumor therapy within 28 days before the first dose, including but not limited to chemotherapy, immunotherapy, macromolecular targeted therapy, or biological therapy such as tumor vaccines, cytokines, or growth factors used to control cancer. Small-molecule targeted therapy or oral fluoropyrimidines within 14 days before the first dose or within 5 half-lives, whichever is longer; or mitomycin C or nitrosoureas within 6 weeks before the first dose.\n11. Receipt of a live attenuated vaccine within 28 days before the first dose or planned receipt of a live attenuated vaccine during the study.\n12. Any active infection requiring systemic treatment by intravenous infusion within 28 days before the first dose.\n13. Treatment within 14 days before the first dose with traditional Chinese patent medicines approved by the NMPA whose package inserts clearly state antitumor indications, or traditional Chinese herbal medicine documented in the medical record as being used for antitumor purposes.\n14. Whole blood or blood component transfusion within 14 days before the first dose.\n15. Treatment with glucocorticoids equivalent to prednisone \\>10 mg\u002Fday or other immunosuppressive agents within 14 days before the first dose.\n16. Participation in another clinical trial and receipt of investigational treatment within 28 days before the first dose, calculated from the date of the last treatment in the previous clinical study, except participation in overall survival follow-up of a study.\n17. Positive human immunodeficiency virus antibody or Treponema pallidum antibody; positive hepatitis B surface antigen and\u002For hepatitis B core antibody with hepatitis B virus DNA above the upper limit of normal of the testing laboratory; or positive hepatitis C antibody with hepatitis C virus RNA above the upper limit of normal of the testing laboratory.\n18. History of active tuberculosis.\n19. Pregnancy or breastfeeding.\n20. Other malignancy that progressed or required treatment within 5 years before screening, except adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or cured carcinoma in situ such as breast carcinoma in situ.\n21. Any other condition that may increase the risk associated with study treatment, interfere with interpretation of study results, affect study compliance, or otherwise make the participant unsuitable for the study in the investigator's judgment.\n22. Any clinically significant gastrointestinal disease, including liver disease, bleeding, inflammation, obstruction, or diarrhea greater than Grade 2.\n23. Current use or use within the past 2 weeks of strong CYP3A enzyme inducers or inhibitors and\u002For strong UGT1A inhibitors.\n24. Prior use of liposomal irinotecan formulation or irinotecan.\n25. Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.",{"count":90,"type":19},[92],"This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of liposomal irinotecan combined with enlonstobart in patients with platinum-resistant recurrent ovarian cancer.\n\nEligible female participants with histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV, will receive liposomal irinotecan and enlonstobart every 2 weeks. Tumor assessment will be performed every 8 weeks. Participants may discontinue study treatment in the event of disease progression, intolerable toxicity, withdrawal of consent, or other reasons judged by the investigator.",[397,398,399,400],"Platinum-resistant Recurrent Ovarian Cancer","Fallopian Tube Cancers","Epithelial Ovarian Cancer","Primary Peritoneal Cancer",[402,403,404,405,406,407,408,409,410,411,412],"Platinum-resistant ovarian cancer","Recurrent ovarian cancer","Epithelial ovarian cancer","Fallopian tube cancer","Primary peritoneal cancer","Liposomal irinotecan","Enlonstobart","PD-1 inhibitor","Objective response rate","Progression-free survival","Overall survival","2026-05-15",{"date":357,"type":30},{"date":416,"type":19},"2026-05-30",{"date":418,"type":19},"2030-05-30",{"name":36,"class":37},{"id":421,"slug":4,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":20,"phases":427,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":62},"100593927","NCT07012798","FOLFOX Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma","A Prospective, Single-arm, Single-center Phase II Clinical Study of Hepatic Artery Infusion Chemotherapy (FOLFOX) Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of Potentially Resectable Locally Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n2. Age \\> 18 years.\n3. Confirmed HCC based on histopathological findings from tumor tissues.\n4. HCC newly diagnosed or recurrent with a history of surgery or ablation, not amenable to curative surgery or transplantation.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to screening.\n7. Tumours were classified as unresectable after a multidisciplinary team review because either:\n\n   1. R0 resection was not feasible\n   2. Sum of tumor diameters ≥5cm\n   3. A maximum of three tumour lesions\n   4. For patients with tumors located in bilateral hepatic lobes, the study requires that the number of tumors in the contralateral hepatic lobe of the larger tumor be less than 3, and the maximum tumor diameter should not exceed 3 cm.\n8. Child-Pugh liver function score A.\n9. Patients with PVTT (portal vein tumor thrombosis) classified as VP1 (tumor thrombus confined to distal second-order portal vein branches without involvement of the primary portal vein bifurcation) or VP2 (tumor thrombus involving second-order portal vein branches) were eligible for enrollment.\n10. Patients with oligometastasis, defined as having a single metastatic organ with three or fewer metastases, each less than 3cm in size were permitted.\n11. No prior radiotherapy or radioembolization to the liver or upper abdomen was allowed. Prior local therapies, such as surgery, radiofrequency ablation, percutaneous ethanol injection or cryoablation, are allowed if the index lesion(s) remain outside of the treatment field or have progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan.\n12. Participants with HBV infection, characterized by positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU\u002Fml or above the limit of detection per local lab standard), must be treated with antiviral therapy, as per institutional practice. Following antiviral therapy initiation, participants must show evidence of HBV stabilization or signs of viral response (eg, reduction HBV DNA levels) prior to study invention. Participants will remain on antiviral therapy for study duration and for 6 months after the last dose of study medication. Participants who test positive for anti HBV with undetectable HBV DNA (\\\u003C10 IU\u002Fml or under the limit of detection per local lab standard) do not require anti-viral therapy prior to enrollment. These subjects will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥10 IU\u002Fml or above the limit of detection per local lab standard). HBV DNA detectable subjects must initiate and remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.\n13. Patients with active HCV infection as characterized by the presence of detectable HCV RNA upon enrollment must be managed per local institutional practice.\n14. Life expectancy of \\>12 weeks.\n15. Body weight \\>30 kg.\n16. Adequate organ and marrow function, as defined below. Criteria \"a,\" \"b,\" \"c,\" and \"f\" cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose.\n\n    1. Hemoglobin ≥9 g\u002FdL\n    2. Absolute neutrophil count ≥1000\u002FµL\n    3. Platelet count ≥75000\u002FµL\n    4. Total bilirubin (TBL) ≤2.0× upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n    5. AST and ALT ≤5×ULN\n    6. Albumin ≥2.8 g\u002FdL\n    7. International normalized ratio (INR) ≤ 1.6. Note: INR prolongation due to anticoagulants for prophylaxis (e.g. atrial fibrillation) in patients without liver cirrhosis could be an exception\n    8. Calculated creatinine clearance ≥40 mL\u002Fminute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance\n    9. 2+ proteinuria or lower urine dipstick reading. Participants having \\> 2+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1 g\u002F24 hours will be ineligible\n17. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n18. Female participants:\n\n    * Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control (a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly.) They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study.\n    * Non-sterilized male partners of a woman of childbearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) throughout this period.\n    * Must show evidence of post-menopausal status or have a negative urinary or serum pregnancy test for female pre-menopausal patients.\n19. Male Participants:\n\n    * Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening throughout the total duration of the study and for drugs that are potentially genotoxic the drug washout period to prevent pregnancy in a partner.\n\nMale participants must not donate or bank sperm during this same time period.\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or infiltrative-type HCC.\n2. Patients with PVTT classified as VP3 (involving first-order portal branches) or VP4 (involving the main portal trunk or contralateral\u002Fbilateral branches) were excluded from the study.\n3. Prior radiotherapy to the liver or upper abdomen.\n4. Participation in another clinical study with an investigational product.\n5. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n6. Receipt of the systematic anticancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, monoclonal antibodies) prior to the first dose of study drug.\n7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n   1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the investigator.\n   2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the investigator.\n8. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.\n10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n11. History of allogenic organ transplantation.\n12. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n    1. Patients with vitiligo or alopecia\n    2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n    3. Any chronic skin condition that does not require systemic therapy\n    4. Patients without active disease in the last 5 years may be included but only after consultation with the investigator\n    5. Patients with celiac disease controlled by diet alone\n13. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n14. History of another primary malignancy except for\n\n    1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    3. Adequately treated carcinoma in situ without evidence of disease\n15. History of leptomeningeal carcinomatosis\n16. History of active primary immunodeficiency\n17. Confirmed HBV infection must not be co-infected with HCV (as indicated by the absence of anti-HCV antibodies) or hepatitis D virus (HDV: as indicated by the absence of anti-HDV antibodies).\n18. Confirmed HCV infection must not be co-infected with HBV as defined by negative HBsAg. Patients with confirmed HCV infection who are negative for HBsAg, but positive for anti-HBV with detectable HBV DNA, are eligible but must be started on active antiviral therapy (for HBV) prior to enrollment to ensure adequate viral suppression (HBV DNA ≤2000 IU\u002FmL).\n19. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n20. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n21. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90days after the last dose of IP.\n22. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n23. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n24. Prior treatment in a previous durvalumab clinical study regardless of treatment arm assignment.",{"count":90,"type":19},[92],"Study Design:\n\nThis is a pilot study with a single arm in a single centre assessing safety and efficacy of durvalumab in combination with bevacizumab and HAIC followed by SBRT. This study will be conducted in selected patients with intermediate or advanced stage HCC not amenable to curative therapy. Approximately 30 patients will be enrolled and receive treatments.\n\nPrimary Objectives:\n\nTo evaluate the possibility of HAIC plus durvalumab and bevacizumab followed by SBRT as conversion therapy for HCC.\n\nSecondary Objective(s):\n\nTo evaluate the efficacy of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC.\n\nTo evaluate the safety of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC.\n\nExploratory Objective(s):\n\nEvaluate the consistency of imaging CR and pathological CR in resected patients, and explore biomarkers associated with prognosis .",[430],"Hepatocellular Carcinoma (HCC)",[432,433,434,435],"Durvalumab","HAIC","SBRT","Conversion Therapy","2026-05-10",{"date":438,"type":30},"2026-05-13",{"date":440,"type":30},"2025-09-25",{"date":442,"type":19},"2026-12-31",{"name":36,"class":37},{"id":445,"slug":4,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":15,"minAge":235,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":20,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":461,"locationsCount":4},"100639889","NCT07589972","Neoadjuvant Trastuzumab, Pertuzumab Plus Metronomic Vinorelbine for Elderly HER2-Positive Breast Cancer","A Multicenter, Prospective Clinical Study of Neoadjuvant Therapy With Trastuzumab Plus Pertuzumab Combined With Metronomic Vinorelbine Chemotherapy in Elderly Patients With Early-Stage HER2-Positive Breast Cancer","Inclusion Criteria:\n\n* Subjects voluntarily participate in this study and sign informed consent.\n* Age ≥70 years at the time of informed consent signing.\n* ECOG performance status (PS) 0-1; expected survival \\>3 months.\n* Primary HER2-positive breast cancer confirmed by histopathology or cytology.\n* Primary tumor diameter \\>2 cm, or axillary lymph node metastasis.\n* Laboratory indicators conform to the following standards:\n\nAbsolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Absolute lymphocyte count (LC) ≥0.5×10⁹\u002FL; Platelet count (PLT) ≥100×10⁹\u002FL; Hemoglobin (Hb) ≥90 g\u002FL; White blood cell count (WBC) 3.0×10⁹\u002FL ≤ WBC ≤15×10⁹\u002FL. Serum biochemistry (no blood transfusion or albumin infusion within 7 days before screening): ALT and AST ≤2.5×ULN; ALT and AST ≤5×ULN in patients with hepatic metastases. ALP ≤2.5×ULN (≤5×ULN for patients with bone tumor metastasis). BUN and Cr ≤1.5×ULN, and creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula).\n\nPT and APTT ≤1.5×ULN, INR ≤1.5×ULN (patients not receiving anticoagulation therapy).\n\nUrine protein \\\u003C2+. If urine protein ≥2+, 24-hour urinary protein quantification ≤1 g.\n\nThyroid-stimulating hormone (TSH) ≤ULN. Left ventricular ejection fraction (LVEF) ≥50%. Patients with abnormal TSH may be enrolled as long as T3 and T4 levels are normal.\n\nExclusion Criteria:\n\n* Stage Ⅳ metastatic breast cancer, or patients who cannot undergo curative surgical resection after neoadjuvant therapy as assessed by investigators.\n* Prior anti-tumor therapies including chemotherapy, endocrine therapy, anti-HER2 biological therapy, or previous breast surgery (excluding diagnostic biopsy for primary breast cancer).\n* Other malignancies diagnosed within 3 years or concurrent malignant tumors at enrollment.\n* The following cases are eligible: Other malignancies treated solely by surgery with continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumors (Ta: non-invasive tumor, Tis: carcinoma in situ, T1: basement membrane-invasive tumor).\n* Major surgery, incisional biopsy or severe traumatic injury within 28 days before study treatment (excluding diagnostic biopsy of primary breast cancer).\n* Persistent unhealed wounds or fractures.\n* History of uncontrolled psychoactive drug abuse or psychiatric disorders.\n\nSevere and\u002For uncontrolled underlying systemic diseases, including:\n\n1. History of hypertensive crisis or hypertensive encephalopathy; uncontrolled hypertension (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg after antihypertensive treatment).\n2. Confirmed heart failure or cardiac systolic dysfunction (LVEF \\\u003C55%).\n3. Grade ≥2 myocardial ischemia, myocardial infarction, arrhythmia (QTc ≥450 ms for males, QTc ≥470 ms for females), or grade ≥2 congestive heart failure (NYHA classification).\n4. Angina pectoris requiring anti-anginal medication.\n\n   * Comorbidities interfering with scheduled treatment, including severe pulmonary dysfunction, active pulmonary disease, or uncontrolled severe infection (≥Grade 2 per CTCAE 5.0).\n   * Allergy to any investigational drug, active ingredients or pharmaceutical excipients.\n   * Subjects with comorbidities that threaten safety or affect study completion, or those unsuitable for enrollment according to investigator judgment.",{"count":451,"type":19},45,[22],"English Translation (Professional Medical Version) This study is a multicenter, prospective clinical trial designed to investigate the efficacy and safety of neoadjuvant therapy with trastuzumab plus pertuzumab combined with metronomic vinorelbine chemotherapy in elderly patients with HER2-positive breast cancer.\n\nEligible patients were aged ≥70 years, with histopathologically confirmed primary HER2-positive breast cancer, and met the indications for neoadjuvant therapy as stipulated in the clinical guidelines for the diagnosis and treatment of breast cancer.\n\nA Simon two-stage design was employed in this study, with a planned total enrollment of 45 patients. In the first stage, 14 patients would be enrolled. If the number of observed responders was no more than 6, the trial would be terminated; otherwise, the trial would advance to the second stage, and the total sample size would be expanded to 45 patients.\n\nThe treatment regimen comprised 6 cycles of trastuzumab combined with pertuzumab (subcutaneous pertuzumab\u002Ftrastuzumab fixed-dose combination was permitted as an alternative to intravenous formulations) plus metronomic vinorelbine therapy. Tumor response was assessed by imaging every 2 cycles. Patients with a confirmed response would complete all 6 cycles of treatment and undergo surgery per investigator assessment; postoperative pathological reports would be evaluated to determine the achievement of tpCR. For non-responders, the treatment regimen would be modified or surgery would be performed at the investigator's discretion.",[455],"Neoadjuvant Therapy in Elderly HER2-Positive Breast Cancer","2026-05-09",{"date":413,"type":30},{"date":459,"type":19},"2026-04-20",{"date":34,"type":19},{"name":36,"class":37},{"id":463,"slug":4,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":327,"enrollmentInfo":468,"targetDuration":4,"studyType":20,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":480,"leadSponsor":482,"locationsCount":4},"100637742","NCT07584018","The DoHAICs Study Expansion Phase","Clinical Study on the Efficacy and Safety of Donafenib Combined With Hepatic Artery Infusion Chemotherapy and Sintilimab as the First-line Treatment for Unresectable Hepatocellular Carcinoma - the DoHAICs Study Expansion Phase","Inclusion Criteria:\n\n* Voluntarily participate in the trial and provide written informed consent.\n* Age between 18 and 80 years (inclusive), regardless of gender.\n* Patients with hepatocellular carcinoma (HCC) clinically diagnosed per the \"Standard for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)\" or confirmed by histology\u002Fcytology.\n* Patients with inoperable or metastatic hepatocellular carcinoma.\n* No prior systemic therapy for advanced disease. Patients who received adjuvant chemotherapy following local therapy are eligible if chemotherapy was completed \\>12 months ago and disease progression or metastasis has occurred.\n* Completion of the last interventional therapy, radiotherapy, or ablation therapy \\>4 weeks prior.\n* For patients with prior hepatectomy, resection must have been R0, and tumor recurrence must have occurred more than 24 months after surgery.\n* At least one measurable lesion as defined by RECIST 1.1 criteria.\n* Life expectancy ≥3 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Child-Pugh score ≤7.\n* Able and willing to comply with the protocol for the observation of adverse events and efficacy.\n* Adequate organ function, defined as meeting the following criteria:\n* Hematological function (without transfusion or granulocyte colony-stimulating factor \\[G-CSF\\] support within 14 days prior to screening):\n* Hemoglobin ≥90 g\u002FL.\n* Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL.\n* Platelet count ≥75 × 10⁹\u002FL.\n* Biochemical tests (without albumin infusion within 14 days prior to screening):\n* Albumin ≥28 g\u002FL.\n* Total bilirubin ≤2 × upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × ULN.\n* Alkaline phosphatase (ALP) ≤5 × ULN.\n* Serum creatinine ≤1.5 × ULN.\n* Coagulation function:\n* International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN.\n* Activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n\nExclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma.\n* History of malignancies other than hepatocellular carcinoma, except under the following circumstances:\n* The patient has undergone potentially curative treatment with no evidence of that disease for 5 years.\n* Successfully resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other carcinoma in situ.\n* Diffuse tumor lesions.\n* History of hepatic encephalopathy, hepatorenal syndrome, or liver transplantation.\n* Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.\n* Central nervous system metastases.\n* History of severe psychiatric illness.\n* Diseases affecting the absorption, distribution, metabolism, or excretion of the investigational drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.).\n* Prior allogeneic stem cell or solid organ transplantation.\n* Prior treatment with anti-VEGF\u002FVEGFR, RAF, MEK pathway targeted therapies (e.g., sorafenib, lenvatinib, regorafenib) or immunomodulators (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies).\n* Prior other systemic anti-tumor therapy, including Chinese herbal medicine with anti-tumor indications, completed less than 2 weeks before study drug initiation; or patients with adverse events from prior therapy not recovered to ≤ Grade 1 per CTCAE (excluding alopecia and Grade 1\u002F2 neuropathy caused by oxaliplatin).\n* Concurrent use of medications known to prolong QTc interval and\u002For induce Torsades de Pointes (TdP), or medications that affect drug metabolism.\n* Past or present congenital or acquired immunodeficiency diseases.\n* Active or history of autoimmune or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyper- or hypothyroidism, asthma requiring bronchodilators, etc.). Patients with vitiligo or asthma that was fully resolved in childhood and requires no intervention in adulthood may be included.\n* Use of systemic immunosuppressive medication within 2 weeks prior to enrollment, or anticipated requirement for such medication during the study, except for:\n* Intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular).\n* Systemic corticosteroids at physiological doses not exceeding 10 mg\u002Fday prednisone or equivalent.\n* Prophylactic use of corticosteroids for hypersensitivity reactions.\n* Known or suspected hypersensitivity to donafenib, drugs of the same class, or history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to any excipient of the investigational drug.\n* Active bleeding or coagulation disorders, bleeding tendency, or undergoing thrombolytic, anticoagulant, or antiplatelet therapy.\n* Thrombotic or thromboembolic events within the past 6 months, such as stroke and\u002For transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.\n* History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months, or any life-threatening bleeding event within the past 3 months.\n* Significant cardiovascular disease, including but not limited to: acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within the past 6 months; congestive heart failure (NYHA class \\>2); poorly controlled arrhythmias requiring pacemaker treatment; uncontrolled hypertension (systolic BP ≥140 mmHg and\u002For diastolic BP ≥90 mmHg).\n* Other clinically significant abnormalities, deemed by the investigator to affect safety evaluation, such as uncontrolled diabetes, chronic kidney disease, Grade II or higher peripheral neuropathy (CTCAE v6.0), abnormal thyroid function, etc.\n* Active or poorly controlled severe infection; active infections including:\n* Positive for Human Immunodeficiency Virus (HIV) (HIV1\u002F2 antibodies).\n* Active Hepatitis B (HBsAg positive or HBV DNA \\>2000 IU\u002FmL with abnormal liver function).\n* Active Hepatitis C (HCV antibody positive or HCV RNA ≥10³ copies\u002FmL with abnormal liver function).\n* Active tuberculosis.\n* Other uncontrolled active infections (CTCAE v6.0 \\> Grade 2).\n* Incomplete recovery from surgery, such as unhealed wounds or severe postoperative complications.\n* Pregnancy, lactation, or patients of childbearing potential unwilling or unable to use effective contraception.",{"count":134,"type":19},[92],"We explored the efficacy and safety of the first-line treatment of unresectable hepatocellular carcinoma with donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab .",[472],"HCC - Hepatocellular Carcinoma",[474,475,476],"Hepatocellular carcinoma;","Hepatic artery infusion chemotherapy","Surgical resection","2026-05-07",{"date":438,"type":30},{"date":334,"type":19},{"date":481,"type":19},"2027-06-01",{"name":36,"class":37},{"id":484,"slug":4,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":490,"targetDuration":4,"studyType":20,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":499,"locationsCount":4},"100638289","NCT07584031","Adebrelimab Plus Full-course Neoadjuvant Therapy for Resectable Locally Advanced ESCC (Phase 2)","A Prospective, Single-Center, Phase II Clinical Trial of Adebrelimab Combined With Full-Course Neoadjuvant Therapy for Watchful Waiting or Surgery in Patients With Resectable Locally Advanced Esophageal Squamous Cell Carcinoma","NAT-ESCC-01","Inclusion Criteria:\n\n* Patients voluntarily participate in this study, sign an informed consent form, and demonstrate good compliance;\n* At least 18 years of age; gender is not restricted;\n* ECOG performance status: 0-1;\n* Patients with histologically confirmed resectable esophageal squamous cell carcinoma clinically staged as (T1N+M0 or T2-4aNanyM0);\n* No prior anticancer therapy for esophageal cancer, including chemotherapy, hormone therapy, radiation therapy, or immunotherapy;\n* Laboratory tests must meet the following criteria (within 7 days prior to baseline enrollment):\n\n  1. Complete blood count (CBC):\n\n     1. Hemoglobin (Hb) ≥ 90 g\u002FL (no blood transfusion within the past 14 days);\n     2. Neutrophil count (NEUT) ≥ 1.5 × 10⁹\u002FL;\n     3. Platelet count (PLT) ≥ 100 × 10⁹\u002FL;\n     4. White blood cell count (WBC) ≥ 3 × 10⁹\u002FL;\n  2. Biochemical Tests:\n\n     1. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN;\n     2. Serum total bilirubin (TBIL) ≤ 1.5×ULN;\n     3. Serum creatinine (Cr) ≤ 1.5×ULN; (or creatinine clearance (CCr) ≥ 60 mL\u002Fmin);\n  3. Coagulation function: Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), and prothrombin time (PT) ≤ 1.5×ULN;\n  4. Thyroid function: Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, FT3 and FT4 levels should also be evaluated; if FT3 and FT4 levels are normal, the patient may be enrolled);\n  5. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%;\n* Female participants must agree to use contraceptive measures, such as an intrauterine device (IUD), oral contraceptives, or condoms, during the study and for 6 months after study completion; they must have a negative serum pregnancy test within 7 days prior to study enrollment and must not be breastfeeding; male participants must agree to use contraceptive measures during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n* Concurrent malignant neoplasms (except for cured basal cell carcinoma of the skin);\n* Diagnosis of cervical esophageal cancer;\n* History of severe hypersensitivity reactions following administration of other monoclonal antibodies;\n* Presence of any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, or nephritis; asthma requiring bronchodilators for medical intervention); however, the following patients are eligible for enrollment: vitiligo, psoriasis, or alopecia not requiring systemic treatment; well-controlled type 1 diabetes; hypothyroidism with normal thyroid function following replacement therapy;\n* Requiring immunosuppressants, or systemic or absorbable topical corticosteroids for immunosuppressive purposes (dose \\> 10 mg\u002Fday of prednisone or other corticosteroids of equivalent potency), and still using them within 2 weeks of the first dose;\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n* Uncontrolled symptoms of brain metastases, spinal cord compression, or carcinomatous meningitis occurring within 4 weeks prior to the first dose, or patients with brain or meningeal disease identified by CT or MRI at screening;\n* Patients with any severe and\u002For uncontrolled medical conditions, including:\n\n  1. Acute or recurrent myocardial ischemia or myocardial infarction; poorly controlled and clinically significant arrhythmias; and heart failure of Class II or higher (New York Heart Association \\[NYHA\\] functional class); LVEF (left ventricular ejection fraction) \\\u003C 50%;\n  2. Active or uncontrolled severe infection (≥ Grade 2 CTC AE infection);\n* Receipt of a prophylactic or attenuated vaccine within 4 weeks prior to the first dose;\n* Other factors, as determined by the investigator, that may lead to forced discontinuation of the study, such as other serious illnesses (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that could compromise the subject's safety.\n* If HBsAg (+) and\u002For HBcAb (+), HBV DNA must be \\\u003C 500 IU\u002FmL (if the local center's lower limit of detection is higher than 500 IU\u002FmL, the investigator may decide on enrollment based on specific circumstances) and the subject must continue to receive effective anti-HBV therapy during the study, or must have already started treatment with entecavir or tenofovir prior to study drug administration;\n* If HCV antibodies are positive, HCV-RNA testing must be performed; subjects with HCV-RNA \\> 10³ copies\u002FmL must be excluded;\n* HIV-positive.",{"count":18,"type":19},[92],"This is a prospective, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced esophageal squamous cell carcinoma. Patients achieving clinical complete response (cCR) after neoadjuvant treatment will be randomized 1:1 to watchful waiting with 2 cycles consolidation chemo-Immunotherapy or standard surgery. Primary endpoint is 2-year DFS. Secondary endpoints include OS, pCR\u002FMPR, R0 resection rate, safety, and quality of life.",[494],"ESCC",{"date":438,"type":30},{"date":497,"type":19},"2026-06-01",{"date":34,"type":19},{"name":36,"class":37},{"id":501,"slug":4,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":506,"targetDuration":4,"studyType":20,"phases":508,"briefSummary":509,"conditions":510,"keywords":514,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":528,"leadSponsor":530,"locationsCount":4},"100636840","NCT07570914","Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases","An Exploratory Clinical Study of Hepatic Arterial Infusion of Liposomal Irinotecan Combined With Oxaliplatin and Capecitabine as Postoperative Adjuvant Therapy for Colorectal Cancer Liver Metastases","Inclusion Criteria:\n\n1. Age 18 to 75 years.\n2. Completion of radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment, with postoperative imaging showing no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease.\n3. Histologically confirmed colorectal cancer liver metastases.\n4. ECOG performance status of 0 or 1.\n5. Expected survival of at least 3 months.\n6. Clinical risk score of 3 or higher.\n7. Adequate bone marrow function, defined as absolute neutrophil count \\>2 × 10\\^9\u002FL, hemoglobin \\>9.0 g\u002FdL, and platelet count \\>100 × 10\\^9\u002FL.\n8. Adequate renal function, defined as serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥30 mL\u002Fmin according to the Cockcroft-Gault formula.\n9. Adequate hepatic function, defined as serum bilirubin ≤1.5 × the upper limit of normal, transaminases ≤2.5 × the upper limit of normal or ≤5 × the upper limit of normal if liver metastasis is present, and alkaline phosphatase ≤5 × the upper limit of normal.\n10. Female participants must not be pregnant or breastfeeding. Women of childbearing potential and male participants must use effective contraception during the study and for 6 months after completion of study treatment.\n11. Good compliance, ability to understand the study procedures, and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Contraindication to capecitabine, oxaliplatin, or irinotecan.\n2. Any history of hepatic interventional therapy, including transarterial infusion, hepatic arterial infusion, or transarterial chemoembolization.\n3. Receipt of adjuvant chemotherapy containing irinotecan after resection of the primary tumor, or receipt of adjuvant therapy without irinotecan with the last dose administered within 3 months before enrollment.\n4. Dihydropyrimidine dehydrogenase deficiency.\n5. History of severe cardiovascular disease resulting in inability to tolerate treatment.\n6. Peripheral neuropathy greater than Grade 1.\n7. History of another malignancy within the previous 5 years, except cured carcinoma in situ or basal cell carcinoma of the skin.\n8. History of allogeneic organ transplantation.\n9. Requirement for renal dialysis.\n10. Breastfeeding, pregnancy, or inadequate contraception in women of childbearing potential.\n11. Uncontrolled concomitant disease, including but not limited to severe active or uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, uncontrolled diabetes, or psychiatric illness that may affect study compliance.\n12. Participation in another clinical trial currently or within 4 weeks before enrollment.\n13. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.",{"count":507,"type":19},28,[92],"This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine as postoperative adjuvant therapy in patients with colorectal cancer liver metastases after radical resection.\n\nEligible participants must have histologically confirmed colorectal cancer liver metastases and have completed radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment. Postoperative imaging must show no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease. Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine every 21 days for 2 to 4 cycles. After 2 cycles, treatment continuation will be determined by the investigator based on efficacy and tolerability.",[511,512,513],"Colorectal Cancer Liver Metastases (CRLM)","Colorectal Cancer","Liver Metastasis",[515,516,517,518,407,519,520,521,522,523],"Colorectal cancer","Colorectal cancer liver metastases","Postoperative adjuvant therapy","Hepatic arterial infusion chemotherapy","Oxaliplatin","Capecitabine","Disease-free survival","Hepatic recurrence-free survival","No evidence of disease","2026-04-29",{"date":526,"type":30},"2026-05-06",{"date":416,"type":19},{"date":529,"type":19},"2032-05-30",{"name":36,"class":37},{"id":532,"slug":4,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":151,"enrollmentInfo":537,"targetDuration":4,"studyType":20,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":547,"locationsCount":62},"100636038","NCT07560488","Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma","Conversion Therapy With Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma: A Prospective, Single-Arm Phase II Study","Inclusion Criteria:\n\n* Written informed consent must be signed prior to initiation of any study-related procedures;\n* Age ≥ 18 years, and ≤75 years, regardless of gender;\n* Clinically diagnosed or histologically\u002Fcytologically confirmed hepatocellular carcinoma (HCC) according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition);\n* No prior anti-tumor therapy for HCC before study treatment\n* Unresectable locally advanced or advanced HCC (CNLC Stage IIa-IIIb).\n* Expected overall survival \\> 6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Child-Pugh score class A or B\n* Adequate organ function defined by the following laboratory parameters:\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL without granulocyte colony-stimulating factor support within 14 days;\n  2. Platelet count ≥ 80×10⁹\u002FL without transfusion within 14 days;\n  3. Hemoglobin \\> 9 g\u002FdL without transfusion or erythropoietin within 14 days;\n  4. Total bilirubin ≤ 1.5×upper limit of normal (ULN); or total bilirubin \\> ULN with direct bilirubin ≤ ULN;\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3×ULN;\n  6. Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL\u002Fmin;\n  7. Adequate coagulation function defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN;\n  8. Normal thyroid function defined as thyroid-stimulating hormone (TSH) within normal limits. Subjects with abnormal baseline TSH but normal total T3 (or FT3) and FT4 are also eligible;\n  9. Myocardial enzymes within normal limits; isolated laboratory abnormalities deemed clinically insignificant by the investigator are permitted.\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose of study drug (Day 1 of Cycle 1). A blood pregnancy test is required if the urine test is inconclusive; They must agree to use adequate contraception during the study period and for 8 weeks after the last dose of study drug;\n* All subjects (male or female) of reproductive potential must use a highly effective contraceptive method with an annual failure rate \\\u003C 1% throughout treatment and for 120 days after the last dose of immunotherapy or 180 days after the last dose of chemotherapy, whichever is longer.\n\nExclusion Criteria:\n\n* Target disease exceptions:\n\n  1. Fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma.\n  2. Recurrent HCC.\n  3. Clinically diagnosed hepatic encephalopathy within the most recent 6 months.\n* Autoimmune hepatitis (requiring liver biopsy confirmation);\n* History of organ transplantation or history of hepatic encephalopathy;\n* Diffuse hepatocellular carcinoma;\n* Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage;\n* History of any renal disease or nephrotic syndrome.\n* Variceal bleeding (esophageal or gastric varices) due to portal hypertension within the past 6 months;severe (Grade 3) varices on endoscopy within 3 months before first dose;evidence of portal hypertension (e.g., splenomegaly \\>10 cm in longest diameter with platelets \\\u003C100×10⁹\u002FL on imaging) with high bleeding risk as assessed by the investigator;\n* Arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other severe thromboembolism.Excluded are catheter-related or port-related thrombosis or superficial venous thrombosis that is stable with standard anticoagulation;\n* Severe bleeding tendency or coagulopathy, or ongoing thrombolytic therapy;\n* Prophylactic low-molecular-weight heparin (e.g., enoxaparin 40 mg daily) is permitted; vitamin K antagonists (e.g., warfarin) are excluded;\n* Long-term use of anti-platelet agents including aspirin, dipyridamole, clopidogrel, or other similar medications;\n* Uncontrolled hypertension despite optimal medical management (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg); history of hypertensive crisis or hypertensive encephalopathy;\n* Symptomatic congestive heart failure (NYHA Class II-IV); symptomatic or poorly controlled arrhythmia; congenital long QT syndrome or QTcF \\>500 ms at screening;\n* History of gastrointestinal perforation and\u002For fistula within the past 6 months; history of bowel obstruction (including partial obstruction requiring parenteral nutrition); extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea;\n* Major surgical procedure (cranial, thoracic, or abdominal) within 4 weeks before first dose, or non-healing wounds, ulcers, or fractures.Core needle biopsy or minor surgery within 7 days before first dose is excluded, except for venous catheter placement for intravenous access;\n* History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or severe pulmonary dysfunction;\n* Acute or chronic active hepatitis B or C infection:HBV DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL;HCV RNA \\>10³ copies\u002FmL;coinfection with HBsAg and anti-HCV antibody;\n* Active tuberculosis (TB), ongoing anti-TB treatment, or anti-TB treatment within 1 year before first dose;\n* Human immunodeficiency virus (HIV) infection (positive HIV 1\u002F2 antibody) or active syphilis;\n* Active or poorly controlled severe infection; severe infection requiring hospitalization (including sepsis, bacteremia, or severe pneumonia) within 4 weeks before first dose;\n* Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years before first dose.Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal\u002Fpituitary insufficiency) is permitted.History of primary immunodeficiency.Subjects with isolated positive autoimmune antibodies will be evaluated at the investigator's discretion;\n* Systemic immunosuppressive drugs within 4 weeks before first dose, excluding topical, inhaled, or intranasal corticosteroids or physiological systemic corticosteroids (≤10 mg\u002Fday prednisone or equivalent).Temporary corticosteroids for acute dyspnea in asthma or COPD are permitted;\n* Live attenuated vaccine within 4 weeks before first dose or planned use during the study period;\n* Chinese herbal medicine with anti-tumor indications, or immunomodulatory agents (including thymosin, interferon, interleukin) within 2 weeks before first dose, except for local administration for pleural effusion or ascites;\n* Uncontrolled or irreversible metabolic disorders, other acute or chronic non-malignant organ diseases, systemic illnesses, or paraneoplastic syndromes that may increase medical risk or confound survival assessment;\n* Diagnosis of another malignancy within 5 years before first dose, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ.For other malignancies diagnosed \\>5 years before enrollment, pathological or cytological confirmation of recurrent\u002Fmetastatic lesions is required;\n* Prior treatment with anti-PD-1, anti-PD-L1\u002FL2, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors;\n* Known hypersensitivity to sintilimab, bevacizumab, ipilimumab N01 or their excipients, or severe hypersensitivity to other monoclonal antibodies;\n* Participation in another interventional clinical trial within 4 weeks before first dose;\n* Female subjects who are pregnant or breastfeeding;\n* Any other acute or chronic diseases, psychiatric disorders, or abnormal laboratory values that may increase risks associated with study participation or study drug administration, or interfere with the interpretation of study results, and that, in the investigator's judgment, render the patient ineligible for participation in this study.",{"count":538,"type":19},43,[92],"Conversion therapy for unresectable intermediate-advanced hepatocellular carcinoma (uHCC) has evolved from systemic therapy to combined local-systemic approaches, but current regimens still have limited surgical conversion rates.\n\nThis prospective, single-arm phase II study evaluates a combination regimen of PD-1 inhibitor (sintilimab) plus CTLA-4 inhibitor (ipilimumab N01), bevacizumab biosimilar, and HAIC for patients with initially unresectable intermediate-advanced HCC. The primary goal is to achieve a higher surgical conversion rate with manageable safety",[472,435],"2026-04-27",{"date":383,"type":30},{"date":58,"type":30},{"date":546,"type":19},"2028-04",{"name":36,"class":37},""]