[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-checkpoint-inhibitors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-checkpoint-inhibitors":455},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,45,82,107,134,159,181,203,229,254,287,310,339,368,390,412,434],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644622",false,"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.","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26,27,28],"Locally Advanced Non-small Cell Lung Cancer (NSCLC)","Thoracic Radiotherapy","Immune Checkpoint Inhibitors","Neoadjuvant Chemoimmunotherapy",[30,31,28],"spatially fractionated radiotherapy","Locally Advanced NSCLC","NOT_YET_RECRUITING","2026-06-22",{"date":35,"type":36},"2026-06-26","ACTUAL",{"date":38,"type":19},"2026-07-01",{"date":40,"type":19},"2028-07-01",{"name":42,"class":43},"Tianjin Medical University Cancer Institute and Hospital","OTHER",1,{"id":46,"slug":4,"hasResults":10,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":55,"conditions":56,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100589912","NCT06960577","Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine\u002FCisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem\u002FCis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","Inclusion Criteria:\n\n* Participants with clinical tumour stage T2-T4aN0\u002F1M0 or T1N1M0 with transitional or mixed transitional cell histology\n* Patients must be planning to undergo radical cystectomy\n* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer\n* ECOG performance status of 0 or 1\n* Minimum life expectancy of 12 weeks at first dose of study medication\n\nExclusion criteria:\n\n* Evidence of lymph node (N2-N3) or metastatic (M1) disease\n* Inoperable tumour(s) with fixation to the pelvic wall on clinical examination\n* Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n* Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem\u002Fcis).\n* Uncontrolled intercurrent illness.",{"count":52,"type":19},150,[54],"PHASE3","The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine\u002Fcisplatin) in a clinical practice setting.",[57,27,58,59,60,61,62],"Urinary Bladder Neoplasms","Methotrexate","Vinblastine","Doxorubicin","Cisplatin","Gemcitabine",[64,65,66,67,68,69,62,61],"Muscle-invasive Bladder Cancer","Bladder Cancer","Immunotherapy","Durvalumab","Perioperative Durvalumab","ddMVAC","RECRUITING","2026-06-10",{"date":73,"type":36},"2026-06-11",{"date":75,"type":36},"2025-05-15",{"date":77,"type":19},"2028-10-31",{"name":79,"class":80},"AstraZeneca","INDUSTRY",59,{"id":83,"slug":4,"hasResults":10,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":20,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":44},"100639000","NCT07579247","Efficacy and Safety of Immune Checkpoint Inhibitors for Refractory Opportunistic Infections in AIDS","A Study on the Efficacy and Safety of Immune Checkpoint Inhibitors in the Treatment of AIDS Complicated With Refractory Opportunistic Infections","Inclusion Criteria:\n\nAge ≥ 18 years. Confirmed HIV-1 infection.\n\nMust have at least one opportunistic infection meeting the \"refractory\" criteria after currently available standard anti-infective treatment, defined as follows:\n\n1. Parvovirus B19: Hemoglobin (Hb) fails to recover (increase \\\u003C10g\u002FL) or requires transfusion maintenance, with reticulocytes persistently \\\u003C1% after 4 weeks of Intravenous Immunoglobulin (IVIG) therapy.\n2. Cytomegalovirus (CMV): Blood\u002Fbody fluid CMV-DNA decrease \\\u003C1 log10 or new\u002Fworsening organ damage after 2 weeks of Ganciclovir or Foscarnet therapy.\n3. Mpox virus: Unhealed lesions, new lesions, necrotic coalescence, or no decrease in viral load after 14 days of Tecovirimat, Cidofovir, or Brincidofovir therapy.\n4. Progressive Multifocal Leukoencephalopathy (PML): Continuous deterioration of neurological symptoms or expanded lesion area on MRI after 3 months of optimized antiretroviral therapy (ART).\n5. Pneumocystis jirovecii pneumonia (PCP): No improvement in oxygenation index or expanded radiological lesions after 8 days of adequate SMZ-TMP therapy.\n6. Cryptococcal meningitis: Persistently positive cerebrospinal fluid (CSF) culture after 4 weeks of induction therapy.\n7. Talaromyces marneffei \u002F Invasive Aspergillosis: Persistently positive culture or progression of radiological\u002Fclinical symptoms after 2 weeks of Amphotericin B or Voriconazole therapy.\n8. Mycobacterium tuberculosis (TB): Persistently positive sputum smear or culture after 2 months of standard anti-tuberculosis therapy.\n9. Nontuberculous mycobacteria (NTM): No improvement in clinical symptoms after 1 month of standard therapy, or culture not turning negative after 3 months.\n\nHigh PD-1 expression on peripheral CD8+ T cells (\\>25%) OR weak pathogen-specific ELISpot response (\\\u003C50 SFCs\u002F10\\^6 cells).\n\nAgreement to use highly effective contraception during the study and for 6 months after the end of the trial.\n\nVoluntary signing of informed consent.\n\nExclusion Criteria:\n\nHistory of active autoimmune disease or autoimmune disease requiring systemic treatment.\n\nPrior organ transplantation or hematopoietic stem cell transplantation. Pregnant or lactating women. Known allergy or anti-drug antibodies to the study drug or its excipients. Prior treatment or exposure to any other immune checkpoint inhibitors. Received immunomodulatory or immunosuppressive therapy (excluding glucocorticoids) within 24 weeks prior to the first dose of the study drug.\n\nPsychiatric disorders or substance abuse that may interfere with the trial. Other severe medical conditions deemed by the investigator as unsuitable for trial participation (e.g., uncontrolled severe heart, liver, or renal failure).",{"count":89,"type":19},50,[91,22],"PHASE1","This prospective, single-arm, open-label study aims to evaluate the efficacy and safety of a PD-1 inhibitor (Sintilimab) combined with standard anti-infective therapy in patients with advanced HIV disease (AHD) who are suffering from refractory opportunistic infections (OIs).\n\nDespite effective antiretroviral therapy (ART), some HIV patients develop severe, hard-to-treat infections (such as CMV, PCP, Tuberculosis, etc.) that do not respond to standard antimicrobial treatments. This is often due to a condition called \"immune exhaustion,\" where the body's infection-fighting T-cells become inactive and express high levels of a protein called PD-1.\n\nSintilimab is an immune checkpoint inhibitor that blocks PD-1, effectively \"waking up\" the exhausted T-cells. While traditionally used for cancer, recent evidence suggests it can safely restore the immune system's ability to clear stubborn infections in HIV patients. In this study, eligible patients with refractory OIs and evidence of immune exhaustion will receive Sintilimab (200 mg intravenously every 3 weeks for a total of 3 doses) alongside their regular treatments. Researchers will monitor patient safety, clinical improvement, and immunological recovery.",[94,95,27,96],"HIV","AIDS","Refractory Opportunistic Infection","2026-05-06",{"date":99,"type":36},"2026-05-12",{"date":101,"type":19},"2026-05",{"date":103,"type":19},"2029-12",{"name":105,"class":106},"Shanghai Public Health Clinical Center","OTHER_GOV",{"id":108,"slug":4,"hasResults":10,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":20,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100560421","NCT06576921","Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction","Efficacy and Safety of Serplulimab Combined With Nab-paclitaxel and SOX as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Age older than 18 and younger than 75 years\n* Primary GC or AEG (Siewert II\u002FIII)confirmed pathologically by endoscopic biopsy\n* Clinical stage T3\u002FT4N+M0 disease as assessed by CT\u002FMRI, PET-CT, and laparoscopy, if feasible\n* At least one measurable lesion according to the RECIST, version 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Surgical treatment after neoadjuvant chemotherapy is planned according to clinical staging criteria.\n* Life expectancy of at least 3 months\n* Acceptable bone marrow, hepatic, and renal function, including: a)Blood routine examination(No blood transfusion within 14 days; No granulocyte colony-stimulating factor (G-CSF) or other hematopoietic stimulating factors were used): white blood cell count ≥3.5 ×109\u002FL, neutrophils ≥1.5 × 109\u002FL, platelet count \\>100 × 109\u002FL, and hemoglobin ≥90 g\u002FL; b)Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome patients, ≤3×ULN); c)Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥60mL\u002F min; d)Coagulation function: activated partial thromboplastin time (APTT), international standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;\n* Written informed consent\n\nExclusion Criteria:\n\n* Squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma, and undifferentiated gastric cancer were confirmed by pathology\n* Positive Her-2 detection (IHC3+ or IHC2+ amplified by FISH detection)\n* Prior chemotherapy, radiotherapy, hormone therapy, targeted therapy, or immunotherapy\n* Contraindications for surgical treatment or chemotherapy\n* Presence of distant metastasis\n* History of other malignant disease within the past 5 years, except: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that have been treated radically and have shown no signs of disease for at least 5 years\n* Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma\u002Fatopy\n* History of immunodeficiency diseases, including human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or transplantation\n* Severe mental disorder\n* Presence of digestive tract obstruction, jaundice, acute infectious diseases, inflammatory bowel disease, Crohn's disease, ulcerative colitis, chronic diarrhea, active tuberculosis\n* Immunosuppressive drugs are required for 2 weeks or within 2 weeks or during the study period, excluding the following: a) intranasal, inhaled, topical or topical steroid injections (e.g. intra-articular injections); b) Physiological dose of systemic corticosteroids (≤10mg\u002F day prednisone or equivalent dose); c) Short-term (≤7 days) use of steroids for the prevention or treatment of non-autoimmune allergic diseases;\n* Patients who have undergone major surgery or received live virus vaccine within 4 weeks\n* Pregnant or breast-feeding women, subjects who are unwilling to receive effective contraception during treatment and within 6 months after the end of treatment (including male subjects who have the ability to impregnate women and female subjects and their male partners)\n* Evidence of bleeding tendency or receiving thrombolytics or anticoagulants\n* According to the criteria of the term Common Adverse Events (NCI-CTCAE V5.0), the corresponding symptoms have been diagnosed;\n* Hepatitis B or hepatitis C virology tests at the time of screening meet any of the following: a) HBsAg positive and HBV-DNA titer ≥104 copy number \u002FmL or ≥2000IU\u002FmL (hepatitis B carriers should ask researchers for appropriate antiviral treatment); b) Active hepatitis C: HCV antibody positive and HCV-RNA higher than the lower detection limit of the assay;\n* Allergic to study drugs\n* The investigator believes that the subjects have other conditions that may affect their adherence to the protocol and evaluation of the study indicators, and the subjects are not suitable to participate in the study.","75 Years",{"count":115,"type":19},116,[22],"This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG.\n\nThe goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG\u002FGC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are:\n\nDoes serlulimab increase the pCR of participants with locally advanced AEG\u002FGC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG\u002FGC.\n\nParticipants will:\n\nEligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg\u002Fm2 intravenously on days 1, OXA 130mg\u002F \u002Fm2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.",[119,27],"Stomach Neoplasms",[121,122,123],"Gastric cancer","Adenocarcinoma of Esophagogastric junction cancer","PD-1 antibody","2026-04-21",{"date":126,"type":36},"2026-04-23",{"date":128,"type":36},"2024-11-15",{"date":130,"type":19},"2026-09-30",{"name":132,"class":43},"Xijing Hospital",5,{"id":135,"slug":4,"hasResults":10,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":44},"100565819","NCT06647134","A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy","Inclusion Criteria\n\nThe criteria are:\n\n* Patients aged 18 years and above\n* English (conversational level) speaking, with the ability to give informed consent\n* Patients with a rheumatologist clinician diagnosis of inflammatory arthritis irAE or PMR irAE following ICI therapy\n\nExclusion Criteria\n\n* Acutely life-threatening or worsening cancer\n* Hearing impairment functionally limiting participation in verbal interview",{"count":140,"type":19},20,"OBSERVATIONAL","To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.",[144,145,27],"Arthritis","Polymyalgia Rheumatica",[147,148,149],"arthritis","polymyalgia rheumatica","immune related adverse events","2026-04-10",{"date":152,"type":36},"2026-04-13",{"date":154,"type":36},"2024-09-11",{"date":156,"type":19},"2028-03-31",{"name":158,"class":43},"M.D. Anderson Cancer Center",{"id":160,"slug":4,"hasResults":10,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":10,"sex":15,"minAge":165,"maxAge":4,"enrollmentInfo":166,"targetDuration":168,"studyType":141,"phases":4,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":44},"100632348","NCT07512518","Observational Cohort Study of Chronic Viral Infection in the Central Nervous System","Central Nervous System Chronic Viral Infections: A Cohort Study","Inclusion Criteria:\n\n1. Age \\> 14 years old.\n2. Confirmed diagnosis of chronic viral infection of the central nervous system (CNS).\n3. Signed informed consent. The diagnosis of Progressive Multifocal Leukoencephalopathy (PML) shall meet one of the following criteria:(1) Neuropathological diagnosis: Pathological examination of brain tissue shows demyelination, bizarre astrocytes, and enlarged oligodendroglial nuclei; immunohistochemical detection of JC virus (JCV) antigen.(2) Clinical + imaging + cerebrospinal fluid (CSF) diagnosis: Clinical manifestations of progressive neurological dysfunction; neuroimaging shows single or multiple asymmetric white matter lesions with large volume, mostly involving the U-fibers, and rare mass effect; detection of JC virus DNA in cerebrospinal fluid. Specific reference shall be made to the 2013 American Academy of Neurology (AAN) diagnostic criteria.\n\nFor the diagnosis of other chronic viral infections of the central nervous system, the clinical manifestations shall be consistent with the characteristics of the relevant diseases, and the relevant viral DNA shall be detected in the cerebrospinal fluid.\n\nThe diagnosis of all cases must be independently confirmed by two physicians from the Encephalitis Professional Group, Department of Neurology, Peking Union Medical College Hospital, with consistent diagnostic results, to be included in the study. For cases with inconsistent diagnoses, the two physicians shall conduct consultations to reach a consensus. Patients with unreached diagnostic consensus shall not be included in the study.\n\nExclusion Criteria:\n\n1. Presence of lumbar puncture contraindications, making it impossible to collect cerebrospinal fluid.\n2. The attending physician and the researcher consider that the detection of virus in cerebrospinal fluid cannot explain the patient's clinical manifestations.\n3. Inability to complete 1-year follow-up.","14 Years",{"count":167,"type":19},66,"1 Year","This research team intends to conduct a real-world cohort study of chronic CNS viral infections represented by PML, to evaluate whether administration of immune checkpoint inhibitors improves long-term outcomes in this patient population.Patients with prior follow-up will be enrolled into a retrospective\u002Fprospective ambidirectional cohort, and newly diagnosed patients will be enrolled into a prospective cohort.",[171,27],"Progressive Multifocal Leukoencephalopathy","2026-03-30",{"date":174,"type":36},"2026-04-06",{"date":176,"type":36},"2023-02-20",{"date":178,"type":19},"2030-10-25",{"name":180,"class":43},"Peking Union Medical College Hospital",{"id":182,"slug":4,"hasResults":10,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":10,"sex":186,"minAge":16,"maxAge":113,"enrollmentInfo":187,"targetDuration":4,"studyType":20,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":44},"100621550","NCT07372079","Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy","Inclusion Criteria:\n\n* Voluntarily join this study, sign the informed consent form, and demonstrate good compliance;\n* Age: 18-75 years old (at the time of signing the informed consent form);\n* ECOG PS score: 0-1; expected survival time exceeding 6 months;\n* Patients with primary breast cancer confirmed by histopathological or cytological examination;\n* Primary tumor diameter \\> 2 cm as measured by local standard assessment methods;\n* Judged by the investigator to meet the American Joint Committee on Cancer (AJCC) 8th edition breast cancer TNM staging criteria as cT2-cT4, cN0-cN3, cM0, with locally advanced or early-stage, unilateral, and histologically confirmed invasive breast cancer;\n* Histopathologically confirmed early-stage triple-negative invasive breast cancer as defined by the latest ASCO\u002FCAP guidelines;\n* At least one measurable lesion according to RECIST 1.1;\n* The patient agrees to undergo breast cancer resection surgery when meeting the surgical criteria after neoadjuvant therapy;\n* PD-L1 expression status is known;\n* Major organ functions are in good condition;\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use acceptable and effective contraception from screening onward and agree to continue these precautions until 12 months after the last dose of the study drug; periodic abstinence and rhythm methods are not acceptable contraceptive methods.\n\nExclusion Criteria:\n\n* Patients with stage IV metastatic breast cancer or other patients deemed by the investigator as unable to achieve curative surgical resection through neoadjuvant therapy;\n* Patients with inflammatory breast cancer;\n* Patients who have had or currently have other malignancies within the past 3 years. The following two conditions may be eligible: other malignancies treated with a single surgical procedure, achieving continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\];\n* Breast cancer patients who have received antitumor therapies such as chemotherapy, endocrine therapy, or immune checkpoint inhibitors within the past 3 years, or who have undergone breast surgery (except diagnostic biopsy for primary breast cancer);\n* Patients who have undergone major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment (except diagnostic biopsy for primary breast cancer);\n* Presence of any active autoimmune disease or a history of autoimmune disease;\n* Patients currently using immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (at a dose \\>10 mg\u002Fday prednisone or equivalent steroids) and continuing such treatment within 2 weeks prior to enrollment;\n* Allergy to any study drug or any component or excipient of the drug;\n* Patients with concomitant diseases judged by the investigator as seriously endangering the subject's safety or affecting study completion, or those deemed unsuitable for enrollment for other reasons.","FEMALE",{"count":188,"type":19},40,[22],"Iparomlimab and Tuvonralimab Injection (QL1706) is a bifunctional combination antibody targeting both programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4). This is a prospective clinical study that plans to enroll screened, eligible early-stage breast-cancer patients to receive neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive four additional AC cycles before surgery. A key feature is the incorporation of an response-guided neoadjuvant therapy（RGN）model to identify sensitive patients who can forgo anthracyclines, thereby reducing long-term cardiotoxicity.",[192,193,27,194],"Breast Cancer","Neoadjuvant Therapy","QL1706","2026-01-19",{"date":197,"type":36},"2026-01-28",{"date":199,"type":19},"2026-04-05",{"date":201,"type":19},"2029-12-30",{"name":42,"class":43},{"id":204,"slug":4,"hasResults":10,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":20,"phases":211,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":44},"100605184","NCT07159217","Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer","A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer","Inclusion criteria:\n\n1. Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.\n2. Age ≥ 18 years and any gender.\n3. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).\n4. At least one measurable lesion (according to RECIST 1.1).\n5. ECOG performance status score of 0-1.\n6. Child-Pugh score ≤ 7 .\n7. HER2 expression confirmed by: Immunohistochemistry (IHC 2+ or 3+); or Fluorescence in situ hybridization (FISH) with HER2\u002FCEP17 ratio ≥2.0; or Next-generation sequencing (NGS) showing HER2 amplification.\n8. No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization.\n9. Expected survival \\> 12 weeks.\n10. Adequate hematological and major organ function.\n\nExclusion criteria：\n\n1. Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.\n2. Pregnant women (positive pregnancy test before medication) or lactating women.\n3. Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.\n4. History of other active malignancies within 5 years prior to screening.\n5. Presence of central nervous system metastasis and\u002For leptomeningeal metastasis.\n6. Unhealed severe wounds, active ulcers, or untreated fractures.\n7. Administration of live vaccines within 30 days prior to randomization.\n8. Active autoimmune disease or history of autoimmune disease.\n9. Presence of clinically significant gastrointestinal disorders.\n10. Presence of clinically significant cardiovascular or cerebrovascular diseases.",{"count":210,"type":19},65,[22],"This trial is a single-arm exploratory phase II clinical study initiated by the investigator.\n\nSubjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.",[214,215,216,27],"Biliary Tract Cancer","Disitamab Vedotin","Lenvatinib",[218,219,216,220],"Biliary tract cancer","Disitamab vedotin","Immune checkpoint inhibitors","2025-08-28",{"date":223,"type":36},"2025-09-08",{"date":225,"type":19},"2025-08-30",{"date":227,"type":19},"2028-05-31",{"name":180,"class":43},{"id":230,"slug":4,"hasResults":10,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":113,"enrollmentInfo":235,"targetDuration":4,"studyType":20,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":44},"100603091","NCT07132008","Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer","Prospective, Multicenter, Randomized Trial of Neoadjuvant Capecitabine and Oxaliplatin (CAPOX) Plus Tislelizumab Versus CAPOX in Microsatellite Stable High-risk Locally Advanced Colon Cancer","Inclusion Criteria:\n\n* Age ≥18 years old and ≤75 years old.\n* Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma.\n* The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.\n* Enhanced CT stage T4 or T1-4 N+ without multiple primary tumors or distant metastasis.\n* The Eastern Cooperative Oncology Group physical status score is 0-1.\n* Life expectancy is expected to be more than 1 year.\n* First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.\n* Appropriate organ function is defined as follows: Hemoglobin level ≥ 60g\u002FL, Neutrophil count ≥ 1.5×10\\^9\u002FL, Platelet count ≥ 75×10\\^9\u002FL, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL, Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL.\n* Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.\n\nExclusion Criteria:\n\n* Enhanced CT stage (T1-3N0M0)\n* Multifocal colorectal cancer.\n* CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis.\n* Tumor obstruction or high risk of obstruction, bleeding, and\u002For perforation requiring emergency surgery or stent placement.\n* Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.\n* History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.\n* Acute exacerbation of important organ diseases (such as but not limited to chronic obstructive pulmonary disease, coronary heart disease, and renal insufficiency) and\u002For severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), American Society of Anesthesiologists score \\> 3 points.\n* Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.\n* Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.\n* Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy.\n* Unable to undergo enhanced CT examination\n* Pregnancy or lactation.\n* Refused to participate in this study.\n* Other situations in which the researcher deems unsuitable for this study.",{"count":236,"type":19},94,[54],"Building on earlier exploratory work, this study further designs a multi-institutional, prospective, randomized clinical trial to evaluate the efficacy and safety of the combination therapy of the immune checkpoint inhibitor Tislelizumab with CAPOX for neoadjuvant treatment in high-risk locally advanced MSS-type colorectal cancer, as well as its impact on patient outcomes. This study aims to provide new evidence for the clinical practice of treating MSS-type colorectal cancer.",[240,193,27],"Colonic Neoplasms",[242,243,244],"Colon cancer","Neoadjuvant chemotherapy","PD-1 inhibitor","2025-08-13",{"date":247,"type":36},"2025-08-20",{"date":249,"type":19},"2025-10-01",{"date":251,"type":19},"2030-09-30",{"name":253,"class":43},"First Affiliated Hospital of Guangxi Medical University",{"id":255,"slug":4,"hasResults":10,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":20,"phases":261,"briefSummary":262,"conditions":263,"keywords":273,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100406441","NCT04572451","Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma","Phase I Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma","Inclusion Criteria:\n\n* SAFETY COHORT\n\n  1. Patients with advanced\u002Fmetastatic\u002Funresectable solid tumors progressed on standard therapies. Patients with melanoma and RCC will make up approximately 30% of total cohort.\n  2. Patients with 1-4 tumor sites that can be irradiated safely\n  3. Age \\> or equal 18 years\n  4. ECOG performance status 0 or 1\n  5. Patients must have normal organ and marrow function as defined below:\n\n     * Leukocytes ≥ 3000\u002FmcL;\n     * absolute neutrophil count ≥ 1500\u002FmcL;\n     * Platelets ≥ 100,000\u002FmcL;\n     * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) ;\n     * Total bilirubin ≤ 1.5 × ULN (except participants with Gilbert's Syndrome who must have normal direct bilirubin)\n     * Serum creatinine ≤ 1.5 × ULN Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam\n  6. Ability to understand and the willingness to sign a written informed consent document.\n  7. Reproductive status\n\n     * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment.\n     * Women must not be breastfeeding.\n     * WOCBP must agree to follow instructions for method(s) of contraception (Appendix 5) for the duration of study treatment plus 5 half-lives of nivolumab plus 30 days (duration of ovulatory cycle), for a total of 155 days post treatment completion. Local laws and regulations may require use of alternative and\u002For additional contraception methods.\n     * WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, but should still undergo pregnancy testing as described in this section.\n     * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (Appendix4) during combination treatment with study treatment BMS-986253 and nivolumab, plus 5 half-lives of nivolumab (∼125 days), plus 90 days (duration of sperm turnover), for a total of 215 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.\n* EFFICACY COHORT\n\n  1. Patients with anti-PD1\u002FPDL1 refractory melanoma\n  2. Patients with 1-4 tumor sites that can be irradiated safely\n  3. Age ≥ 18 years\n  4. ECOG performance status 0 or 1\n  5. Patients must have normal organ and marrow function as defined above for safety cohort\n  6. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam\n  7. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Known or suspected CNS metastases, with the following exceptions:\n\n   a) Subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following 18 radiation and\u002For surgical treatment at the time of randomization. b) Subjects must be off steroids for at least 2 weeks prior to initiation of investigational therapy c) Subjects with signs or symptoms of brain metastases are not eligible unless brain metastases are ruled out by computed tomography or magnetic resonance imaging.\n2. Medical History and Concurrent Diseases\n\n   * Patients who are receiving any other investigational agents.\n   * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and BMS-986253\n   * Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n   * Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:\n\n     i. Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack (TIA) within the 6 months prior to consent ii. Uncontrolled angina within the 3 months prior to consent iii. Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, or poorly controlled atrial fibrillation) within a month prior to consent iv. QTc prolongation \\> 480 msec v. History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, congestive heart failure with New York Heart Association \\[NYHA\\] functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled deep venous thrombosis, etc) vi. Cardiovascular disease-related requirement for daily supplemental oxygen vii. History of two or more coronary revascularization procedures within the 3 months prior to consent viii. Subjects with history of myocarditis, regardless of etiology\n   * A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent\n   * Subjects with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).\n   * Subject has been administered prior chemotherapy or immunotherapy at any time, and any with radiation therapy within 4 weeks prior to time of consent or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to previously administered agent.\n\n     1. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n     2. Subjects with endocrinopathy which is adequately controlled with hormone replacement therapy are an exception to this criterion and may qualify for the study.\n   * If subject underwent major surgery, subject must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n   * Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n   * A known or underlying medical condition that, in the opinion of the investigator could make the administration of study drug hazardous to the subject or could adversely affect the ability of the subject to comply with or tolerate study therapy.\n   * Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with the study drugs.\n   * Subjects who are unable to undergo venipuncture and\u002For tolerate venous access\n   * Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to initiation of study drug therapy\n   * Subjects who are on immunosuppressive therapy (systemic steroids 10mg and more daily use)\n   * Prisoners or subjects who are involuntarily incarcerated\n   * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness\n   * Inability to comply with restrictions and prohibited activities and treatments",{"count":89,"type":19},[91],"Nivolumab (and other agents affecting the anti-programmed death-1 \\[anti-PD-1\\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance. In this phase I\u002FIb study, radiation will be used in combination with IO agents nivolumab and anti-IL-8 (BMS-986253) to assess toxicity by organ system and then assess the preliminary efficacy of the treatment regimen. In Part 1, the study will determine the safe doses of radiation by organ site in conjunction with nivolumab and BMS-986253. In Part 2, the treatment regimen will be investigated in melanoma, prioritizing acral melanoma, to describe the response rate to treatment as well as other clinical and safety outcomes. The study will also provide the opportunity to evaluate changes in the tumor microenvironment induced by the treatment.",[264,265,266,267,268,269,270,27,271,272],"Melanoma","Unresectable Solid Tumors","Neoplasms","Neoplasms by Histologic Type","Neoplasms by Site","Antineoplastic Agents, Immunological","Antineoplastic Agents","Molecular Mechanisms of Pharmacological Action","Nivolumab",[274,275,276],"Anti-PD-1 monoclonal antibody (mAb)","Anti-IL-8","Stereotactic Body Radiotherapy (SBRT)","2025-07-29",{"date":279,"type":36},"2025-08-01",{"date":281,"type":36},"2021-11-29",{"date":283,"type":19},"2027-05-31",{"name":285,"class":43},"Yana Najjar",2,{"id":288,"slug":4,"hasResults":10,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":20,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":44},"100595582","NCT07034326","Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer","Observation on the Clinical Efficacy of Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* (1) Non-tumor patients with stage Ⅱ, ⅢA, ⅢB (N2) non-small cell lung cancer diagnosed by pathology or cytology after surgery; (2) driver mutations negative patients; (3) Postoperative adjuvant chemotherapy was received for 1 to 4 cycles;(4)conforms to two qi syndrome of traditional Chinese medicine syndrome differentiation diagnosis of patients; (5) aged 18 to 80 years old; (6) expected lifetime \\> 6 months; (7) ECOG 0 to 2 points; (8) patients willing to accept this solution treatment, adherence to the good.\n\nExclusion Criteria:\n\n* (1) Patients with other malignant tumors in the past or at the same time within 5 years; (2) has a serious heart, liver and kidney damage, or other serious complications; (3) the R1, R2, need after resection, postoperative adjuvant radiotherapy patients; (4) with mental disorders; (5) has a variety of drug allergy, allergic constitution; (6) in pregnancy or lactation women.","80 Years",{"count":295,"type":19},405,[22,54],"Postoperative immunoadjuvant therapy has been proven to significantly reduce the risk of recurrence after resectable NSCLC, and has become a new standard of postoperative adjuvant therapy for stage II-III NSCLC. Immunotherapy faces challenges such as immune resistance, heterogeneity of biomarker expression, and limitation of immune-suitable population. How to reduce the rate of recurrence and metastasis after surgery, enhance the therapeutic effect of immunotherapy, and then prolong the survival period and improve the quality of life, has become an urgent problem facing the current clinical. Based on the standards of evidence-based medicine, this study for the first time carried out a large sample, multi-center, randomized parallel controlled clinical study to obtain high-quality clinical evidence of the effectiveness and safety of electro-acupuncture and Zilongjin tablet synergic treatment, and formed a standard treatment plan of traditional Chinese medicine.",[299,300,27],"Non-Small Cell Lung Cancer","Electroacupuncture","2025-06-15",{"date":303,"type":36},"2025-06-24",{"date":305,"type":36},"2025-01-01",{"date":307,"type":19},"2028-12-31",{"name":309,"class":43},"Kong Fanming",{"id":311,"slug":4,"hasResults":10,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":20,"phases":318,"briefSummary":320,"conditions":321,"keywords":324,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":44},"100501758","NCT05813418","Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment","Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients","Ibe2i-TIPCI","Inclusion Criteria:\n\n* patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and\u002For anti-CTLA-4)\n* age \\> 18\n* followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital\n* who received verbal and written information, and signed the consent form for the study\n\nExclusion Criteria:\n\n* non ICPI treated patients\n* patient who received a first line of ICPI treatment\n* patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)",{"count":52,"type":19},[319],"NA","In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.\n\nRecently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.",[66,27,322,323],"Immune-related Adverse Event","Predictive Biomarkers",[325,326,322,327,328,329],"immunotherapy","immune checkpoint inhibitors","predictive biomarkers","plasmatic cytokines","circulating immune subpopulations","2025-06-03",{"date":332,"type":36},"2025-06-04",{"date":334,"type":36},"2021-07-02",{"date":336,"type":19},"2025-12",{"name":338,"class":43},"Centre Hospitalier Universitaire, Amiens",{"id":340,"slug":4,"hasResults":10,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":346,"targetDuration":348,"studyType":141,"phases":4,"briefSummary":349,"conditions":350,"keywords":354,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":44},"100591050","NCT06975384","The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer","The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging","Nezha","Cohort 1:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Histologically confirmed diagnosis of NSCLC;\n3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;\n5. Treatment naïve;\n6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed consent to participate in the study;\n\nExclusion Criteria:\n\n1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and\u002For anaplastic lymphoma kinase (ALK) fusion and\u002For ROS proto-oncogene 1 (ROS1) fusion-positive;\n2. Presence of other malignant tumors or malignant diseases within 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Patients receiving sleep medication;\n5. Prior participation in other clinical drug trials;\n6. Symptomatic brain metastasis;\n7. Inability to complete scale assessments.\n\nCohort 2:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Histologically confirmed diagnosis of SCLC；\n3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;\n4. ECOG PS of 0-1;\n5. Treatment naïve;\n6. Presence of at least one measurable lesion according to the RECIST v1.1 ;\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed consent to participate in the study;\n\nExclusion Criteria:\n\n1. Presence of other malignant tumors or malignant diseases within 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Patients receiving sleep medication;\n4. Prior participation in other clinical drug trials;\n5. Symptomatic brain metastasis;\n6. Inability to complete scale assessments.\n\nCohort 3:\n\nInclusion Criteria:\n\n1. Age ≥18 years old;\n2. Pathologically diagnosed as NSCLC;\n3. Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;\n4. At least one measurable lesion can be evaluated according to the RECIST v1.1;\n5. Treatment naïve;\n6. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy as neoadjuvant therapy;\n7. Cardiopulmonary function can withstand surgery;\n8. Informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. EGFR-sensitizing mutation and\u002For ALK fusion and\u002For ROS1 fusion-positive;\n2. Presence of other malignant tumors or malignant diseases within 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Patients receiving sleep medication;\n5. Prior participation in other clinical drug trials;\n6. Symptomatic brain metastasis;\n7. Inability to complete scale assessments.\n\nCohort 4:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Pathologically diagnosed as NSCLC;\n3. Pathologically stage confirmed as early stage of IA-IIIA;\n4. Available for tumor tissue samples;\n5. Treatment naïve;\n6. Receiving radical surgery;\n7. Informed consent to participate in the study;\n\nExclusion Criteria:\n\n1. Presence of other malignant tumors or malignant diseases within 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Patients receiving sleep medication;\n4. Prior participation in other clinical drug trials;\n5. Inability to complete scale assessments.\n\nCohort 5:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Histologically confirmed diagnosis of NSCLC;\n3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;\n4. ECOG PS of 0-1;\n5. Treatment naive;\n6. Presence of at least one measurable lesion according to the RECIST v1.1;\n7. Receiving targeted therapy or combination with chemotherapy;\n8. Informed consent to participate in the study;\n9. Driver gene-positive.\n\nExclusion Criteria:\n\n1. Presence of other malignant tumors or malignant diseases within 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Patients receiving sleep medication;\n4. Prior participation in other clinical drug trials;\n5. Symptomatic brain metastasis;\n6. Inability to complete scale assessments.",{"count":347,"type":19},1270,"5 Years","This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received either first-line therapy (ICIs or targeted agents) or neoadjuvant therapy with ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early non-small-cell lung cancer (NSCLC) receiving surgery.",[351,352,27,353],"Lung Cancer","Sleep Disturbance","Cancer, Treatment-Related",[351,27,352,355,356,357,358],"Circadian Rhythm","Cancer Progression","Prognosis","Biomarker","2025-05-09",{"date":361,"type":36},"2025-05-16",{"date":363,"type":36},"2024-11-01",{"date":365,"type":19},"2030-12-31",{"name":367,"class":43},"Second Xiangya Hospital of Central South University",{"id":369,"slug":4,"hasResults":10,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":374,"targetDuration":348,"studyType":141,"phases":4,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":389,"locationsCount":44},"100475980","NCT05477979","The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)","Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging (STRESS-LUNG)","Cohort 1 (STRESS-LUNG-1):\n\nInclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically confirmed diagnosis of NSCLC;\n3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and\u002For anaplastic lymphoma kinase (ALK) gene and\u002For ROS proto-oncogene 1 (ROS1) fusion-positive;\n2. Combined with other malignant tumors in the past 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Current receiving anti-depressive or anti-anxiety therapy;\n5. Previous treatment with other clinical drug trials;\n6. Patients with symptomatic brain metastasis;\n7. Can't cooperate with psychological scale assessment;\n\nCohort 2 (STRESS-LUNG-2):\n\n1. Age ≥ 18 years；\n2. Pathologically diagnosed as small cell lung cancer；\n3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Combined with other malignant tumors in the past 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Current receiving anti-depressive or anti-anxiety therapy;\n4. Previous treatment with other clinical drug trials;\n5. Patients with symptomatic brain metastasis;\n6. Can't cooperate with psychological scale assessment;\n\nCohort 3 (STRESS-LUNG-3):\n\n1. Age ≥18 years ；\n2. Pathologically diagnosed as non-small cell lung cancer;\n3. Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;\n4. At least one measurable lesion can be evaluated according to the RECIST 1.1 standard；\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Receiving PD-1\u002FPD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.\n\n6\\. Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and\u002For anaplastic lymphoma kinase (ALK) gene and\u002For ROS proto-oncogene 1 (ROS1) fusion-positive;\n2. Combined with other malignant tumors in the past 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Current receiving anti-depressive or anti-anxiety therapy;\n5. Previous treatment with other clinical drug trials;\n6. Can't cooperate with psychological scale assessment;\n\nCohort 4 (STRESS-LUNG-4):\n\n1. Age ≥18 years;\n2. Pathologically diagnosed as non-small-cell lung cancer；\n3. Pathologically stage conformed as early stage of IA-IIIA\n4. Available for tumor tissue samples；\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Receiving radical surgery;\n7. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Combined with other malignant tumors in the past 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Current receiving anti-depressive or anti-anxiety therapy;\n4. Previous treatment with other clinical drug trials;\n5. Can't cooperate with psychological scale assessment;",{"count":375,"type":19},750,"This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.",[351,378,27,353],"Psychological Stress",[380,220,381,382,357,358],"Lung cancer","Psychological stress","Cancer progression","2025-02-21",{"date":385,"type":36},"2025-02-25",{"date":387,"type":36},"2020-06-01",{"date":307,"type":19},{"name":367,"class":43},{"id":391,"slug":4,"hasResults":10,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":20,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":410,"locationsCount":44},"100550367","NCT06446154","Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma","Fruquintinib in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors : A Single-arm, Phase II Study","Inclusion Criteria:\n\n* patients aged 18 years or older\n* with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria\n* who had previously received immune checkpoint inhibitors\n* had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria\n* had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* had a Child-Pugh liver function score of 7 or less\n* had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109\u002Fl, platelet count ≥60×109\u002Fl, total bilirubin \\\u003C 30μmol\u002Fl, albumin ≥ 30g\u002Fl, aspartate transaminase and alanine transaminase ≤ 5×upper limit of the normal, creatinine clearance rate of ≤ 1.5×upper limit of the normal, and left ventricular ejection ≥ 45%)\n\nExclusion Criteria:\n\n* history of HIV, organ allograft\n* combined with other malignant tumors\n* evidence of hepatic decompensation, bleeding diathesis or event\n* allergy to the investigational agents or any agent given in association with this trial\n* incomplete medical information.",{"count":397,"type":19},36,[22],"Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC.\n\nAs a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor -1\u002F2\u002F3 (VEGFR 1\u002F2\u002F3), fruquintinib had demonstrated a strong antitumor efficacy in colorectal cancer patients who had previously received standard chemotherapy. Compared with placebo, fuquinitinib significantly extended overall survival in patients with metastatic colorectal cancer (median OS, 9.3 months vs 6.6 months; HR, 0.65; p\\\u003C0.001) and progression-free survival (median PFS, 3.7 months vs 1.8 months; HR, 0.26; p\\\u003C0.001). Additionally, a phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median PFS of 7.4 months and a tumor response rate of 31.6%.\n\nTherefore, we intend to conduct this clinical study to explore the efficacy and safety of fruquintinib as second-line treatment for patients with unresectable HCC previously treated with immune checkpoint inhibitors.",[401,27,402,403],"Hepatocellular Carcinoma","Anti-angiogenic Therapy","Second-line Treatment","2024-12-29",{"date":406,"type":36},"2024-12-31",{"date":408,"type":36},"2024-12-27",{"date":38,"type":19},{"name":411,"class":43},"Sun Yat-sen University",{"id":413,"slug":4,"hasResults":10,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":418,"sex":15,"minAge":16,"maxAge":293,"enrollmentInfo":419,"targetDuration":4,"studyType":20,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":4},"100537559","NCT06279403","Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma","Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\nVoluntary consent to participate in this study and signing of an informed consent form.\n\nMale or female participants aged ≥18 years and \\\u003C80 years. Histologically diagnosed with clear cell carcinoma or predominantly clear cell renal cell carcinoma.\n\nClinical stage determined by CT or MRI: anyTN1M0 or anyTN0M1; IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs; and the primary tumor (unilateral or bilateral) is resectable.\n\nECOG performance status: 0 or 1. No clinically significant cardiac, bone marrow, hepatic, or renal function abnormalities.\n\nA willingness and ability to comply with testing and follow-up procedures.\n\nExclusion Criteria:\n\nNon-clear cell carcinoma. Severe liver or kidney dysfunction, or other severe diseases. Immune deficiency, organ transplantation, or autoimmune diseases. Severe central nervous system diseases. Other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.\n\nUnable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons.",true,{"count":140,"type":19},[22],"Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.\n\nPrimary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \\\u003C10% in the primary tumor after nephrectomy.\n\nStudy Design:\n\nPopulation: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.\n\nSample Size: 20 participants.\n\nPatient Grouping: Non-randomized.\n\nInterventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.",[423,27,424],"Clear-cell Metastatic Renal Cell Carcinoma","Cytoreductive Nephrectomy","2024-02-25",{"date":427,"type":36},"2024-02-28",{"date":429,"type":19},"2024-03-01",{"date":431,"type":19},"2029-03-01",{"name":433,"class":43},"RenJi Hospital",{"id":435,"slug":4,"hasResults":10,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":20,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":4},"100508272","NCT05898256","Cadonilimab in the Treatment of Recurrent\u002FMetastatic Nasopharyngeal Carcinoma","A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cadonilimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. The subject must sign the written informed consent form (ICF) voluntarily；\n2. Age ≥18 years and ≤65 years；\n3. Subjects with histopathological diagnosis of nasopharyngeal carcinoma；\n4. Primarily metastatic (stage IVB as defined by AJCC staging system for NPC, eighth edition) or recurrent\u002Fmetastatic NPC that is not amenable to local regional treatment or curative treatment and at least 6 months after radical treatment；\n5. Has not received prior systemic treatment;\n6. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status\n7. Subject must have a measurable target lesion based on RECIST v1.1;\n\nExclusion Criteria:\n\n1. Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs;\n2. Prior therapy as follow:\n\n   Anti-PD-1, anti-PD-L1 or anti-CTLA-4; Concurrent medical condition requiring the use of cortisol (\\>10mg\u002Fday Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment（Except：inhalation or topical corticosteroids）.\n3. Any active malignancy ≤ 2 years before randomization except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)；\n4. Female patients who are at pregnancy or lactation.","65 Years",{"count":140,"type":19},[91,22],"This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Cadonilimab in combination with gemcitabine\u002Fcisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.",[445,27],"Nasopharyngeal Carcinoma","2023-06-01",{"date":448,"type":36},"2023-06-12",{"date":450,"type":19},"2023-08-01",{"date":452,"type":19},"2026-07-31",{"name":454,"class":43},"Guangxi Medical University",""]