[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hunan Cancer Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":579},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,41,69,95,126,153,179,204,229,251,281,301,323,348,366,392,412,427,450,473,496,514,538,559],{"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":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644661",false,"NCT07674368","Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia \u002F Mixed","A Prospective Single-Arm Clinical Study of Recakimab for Lorlatinib-Induced Hypercholesterolemia \u002F Mixed Hyperlipidemia","Inclusion Criteria:\n\n1. Aged ≥ 18 years on the day of signing the informed consent form, with no gender restriction;\n2. Patients with unresectable stage IIIB\u002FIIIC\u002FIV non-small cell lung cancer (NSCLC) confirmed by cytology or histology (staging defined per the 9th edition of the International Association for the Study of Lung Cancer (IASLC) Staging Manual in Thoracic Oncology);\n3. Positive ALK fusion confirmed by genetic testing;\n4. Developed Grade 1-3 hypercholesterolemia adverse events after lorlatinib treatment (per CTCAE Version 5.0);\n5. Fasting triglyceride level ≤ 5.6 mmol\u002FL at screening;\n6. Willing and able to comply with scheduled study visits, treatment regimens, laboratory tests and all other study procedures.\n\nExclusion Criteria:\n\n1. Subjects with known hypersensitivity to the investigational product, or a history of severe hypersensitivity reactions to other antibody-based drugs;\n2. Diagnosed with familial hypercholesterolemia per the Simon Broome Criteria;\n3. Received other PCSK9 inhibitors within 6 months prior to screening;\n4. Uncontrolled hypercholesterolemia (total cholesterol above the upper limit of normal) existed before lorlatinib initiation;\n5. Prior diagnosis of New York Heart Association (NYHA) Class III-IV cardiac dysfunction;\n6. Prior diagnosis of atherosclerotic cardiovascular disease (ASCVD), including acute coronary syndrome, stable coronary artery disease, post-revascularization status, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic artery disease, etc.;\n7. Prior diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response;\n8. Uncontrolled hypertension at screening or randomization (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n9. Prior diagnosis of diseases that significantly affect lipid levels, including nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;\n10. Prior diagnosis of Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus at screening (HbA1c \\>8.5%);\n11. Active infectious disease at screening judged by the investigator to render the subject ineligible for trial participation;\n12. Participation in another interventional clinical trial within 1 month before screening (excluding screen failures), or within 5 half-lives of the investigational product at screening (whichever duration is longer);\n13. History of drug abuse, illicit substance use, or chronic alcohol abuse prior to screening;\n14. Major surgery within 3 months before screening, or planned major surgery during the study period;\n15. Chronic continuous or repeated systemic glucocorticoid use within 3 months prior to screening (topical administration excluded, e.g., intra-articular, intranasal, inhaled, cutaneous external use; chronic continuous use defined as ≥7 consecutive days; repeated use defined as cumulative administration ≥3 courses);\n16. Weight-loss medication use or weight-altering bariatric surgery within 2 months prior to screening;\n17. Any laboratory test value meeting the following criteria at screening or randomization:\n\n    1. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² (calculated via the MDRD formula);\n    2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 times the upper limit of normal (ULN); for patients with liver metastases, ALT\u002FAST \\>5×ULN; or total bilirubin \\>1.5×ULN;\n    3. Creatine kinase (CK) \\>3×ULN;\n    4. Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or \\>1.5×ULN;\n    5. Positive human immunodeficiency virus antibody (HIV-Ab) or hepatitis C virus antibody (HCV-Ab); positive hepatitis B surface antigen (HBsAg) with HBV-DNA ≥1000 copies\u002FmL (or ≥200 IU\u002FmL; if the assay lower limit exceeds 1000 copies\u002FmL or 200 IU\u002FmL, HBV-DNA ≥ assay lower limit);\n    6. Positive pregnancy test;\n18. Planned implantation of cardiac pacemaker, cardiac resynchronization therapy (CRT), implantable cardioverter-defibrillator (ICD), or equivalent device during the study period;\n19. Positive human immunodeficiency virus antibody (HIV-Ab) or hepatitis C virus antibody (HCV-Ab); positive hepatitis B surface antigen (HBsAg) with HBV-DNA ≥1000 copies\u002FmL (or ≥200 IU\u002FmL; if the assay lower limit exceeds 1000 copies\u002FmL or 200 IU\u002FmL, HBV-DNA ≥ assay lower limit);\n20. Judged by the investigator to be unsuitable for subcutaneous injection;\n21. The investigator determines the subject has poor compliance or any other factor precluding trial participation, including but not limited to conditions placing the subject at unacceptable risk or likely confounding study results.","ALL","18 Years",{"count":18,"type":19},29,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","This prospective single-arm clinical study plans to enroll 29 participants with unresectable stage IIIB-IV ALK fusion-positive non-small cell lung cancer (NSCLC). Eligible patients must be aged ≥18 years with an ECOG performance status of 0-2 and have developed grade 1-3 hypercholesterolemia adverse events (AEs, per CTCAE 5.0) after lorlatinib treatment. All subjects will receive recakimab 300 mg administered once every 8 weeks.\n\nThe primary endpoint is the percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 16. Secondary endpoints include absolute change in LDL-C at week 16; percentage and absolute change in LDL-C at week 32; percentage and absolute changes from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol\u002FHDL-C ratio, ApoB\u002Fapolipoprotein A1 (ApoA1) ratio, lipoprotein(a) \\[Lp(a)\\] and triglycerides (TG) at weeks 16 and 32; proportion of patients whose hypercholesterolemia AEs return to normal at weeks 16 and 32; LDL-C target achievement rate at weeks 16 and 32; and safety profile related to recakimab.",[25],"ALK Fusion-positive Non-small Cell Lung Cancer",[27],"lunng cancer","NOT_YET_RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":19},"2026-07-10",{"date":36,"type":19},"2028-08-01",{"name":38,"class":39},"Hunan Cancer Hospital","OTHER",1,{"id":42,"slug":4,"hasResults":10,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":15,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100644984","NCT07676383","Precision Navigation to Improve Community Cancer Screening Participation: A Dual-Cohort Cluster Randomized Trial","Effectiveness and Mechanisms of a Precision Navigation Intervention to Improve Community Cancer Screening Participation: A Dual-Cohort Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 45 to 74 years.\n2. Permanent resident of a participating community, defined as having lived in the community for at least 6 months during the past 12 months.\n3. Participating in the urban cancer screening program.\n4. Identified by the program risk assessment questionnaire as being at high risk for at least one of the following cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer.\n5. Has not yet completed the corresponding free clinical screening test for the high-risk cancer type or types.\n6. Able to complete electronic questionnaires and read intervention materials independently or with assistance. Paper materials and staff explanation will be provided for participants who do not use smartphones.\n7. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Previously diagnosed with any of the target cancers, including lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer.\n2. Severe cognitive impairment, severe mental illness, or other conditions that prevent the participant from receiving the intervention or completing study questionnaires.\n3. Planning to be away from the community for a long period during the next 6 months, defined as cumulative absence of more than 3 months.\n4. Currently participating in another interventional study that may affect cancer screening behavior.",true,"45 Years","74 Years",{"count":51,"type":19},1500,[53],"NA","This study will evaluate whether a precision navigation intervention can help community residents at high risk for cancer complete recommended cancer screening. The study will be conducted in communities participating in an urban cancer screening program in China.\n\nEligible participants will be adults aged 45 to 74 years who are permanent residents of participating communities and have been identified as being at high risk for at least one of five cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer. Participants must not have completed the corresponding free clinical screening before enrollment.\n\nThis is a dual-cohort, cluster randomized controlled trial. Communities, rather than individual participants, will be assigned to one of three groups: a precision navigation group, a usual health education group, or a waiting control group. Participants will be classified into two cohorts according to the number of cancers for which they are assessed as high risk. Cohort A will include participants at high risk for three or more cancers, and Cohort B will include participants at high risk for one or two cancers.\n\nParticipants in the precision navigation group will receive a personalized navigation report matched to their risk profile. The report will explain the screening tests most relevant to them, help them understand screening choices, and provide practical steps to support screening completion. Participants in the usual health education group will receive general cancer screening education materials. Participants in the waiting control group will not receive active screening promotion during the main intervention period, but will receive general education materials after the primary assessment.\n\nThe main outcome is whether participants complete the recommended cancer screening during follow-up. The study will also assess changes in screening-related decision conflict, anxiety, self-efficacy, and behavioral intention. A subgroup of participants will provide blood samples before and after the intervention to explore possible biological mechanisms related to stress, inflammation, and screening behavior.\n\nThe results may help improve community-based cancer screening programs and provide evidence for using personalized navigation strategies to increase screening participation among high-risk populations.",[56,57,58,59,60,61],"Cancer Screening","Lung Cancer","Breast Cancer","Colorectal Cancer","Upper Gastrointestinal Cancer","Liver Cancer","2026-06-24",{"date":29,"type":32},{"date":65,"type":19},"2026-06",{"date":67,"type":19},"2027-02",{"name":38,"class":39},{"id":70,"slug":4,"hasResults":10,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":10,"sex":75,"minAge":16,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":20,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100637803","NCT07627620","Camrelizumab Combined With Famitinib Malate and Chemotherapy for Treatment of Recurrent\u002F Metastatic Cervical Cancer","A Multi-Center Phase II Clinical Study of Camrelizumab Combined With Famitinib Malate and Platinum-based Chemotherapy in the Treatment of Recurrent\u002FMetastatic Cervical Cancer","Inclusion Criteria:\n\n1. Female aged 18-75 years.\n2. Histopathologically confirmed recurrent\u002Fmetastatic cervical squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy.\n3. No prior systemic anti-cancer therapy for recurrent\u002Fmetastatic disease.\n4. According to RECIST v1.1 criteria, the patient must have at least one measurable lesion.\n5. Able to normally swallow drug tablets\n6. Has adequate organ function.\n7. Willing to participate and able to comply with research programme requirements.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Estimated life expectancy of more than 3 months.\n\nExclusion Criteria:\n\n1. Has any malignancy \\\u003C5 years prior to study entry.\n2. Known to have brain or meningeal metastasis.\n3. Known to have autoimmune disease.\n4. Received live vaccinations 4 weeks before randomization or during the study period.\n5. Known allergies and contraindications to the investigational drug or any of its components.","FEMALE","75 Years",{"count":78,"type":19},54,[80],"PHASE2","This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent\u002Fmetastatic cervical cancer.",[83],"Cervical Cancer",[83,85,86,87],"Chemotherapy","Camrelizumab","Famitinib malate","2026-05-31",{"date":90,"type":32},"2026-06-04",{"date":29,"type":19},{"date":93,"type":19},"2029-03-30",{"name":38,"class":39},{"id":96,"slug":4,"hasResults":10,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":20,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100580700","NCT06840704","Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer","Immunonutrition in Reducing Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer: a Prospective, Randomized, Controlled, Open-label Clinical Trial","Relief","Inclusion Criteria:\n\n1. The subject voluntarily participates in this clinical study, understands the study procedures, and is able to provide written informed consent.\n2. Age ≥ 18 years.\n3. Pathologically confirmed diagnosis of lung cancer, including non-small cell lung cancer and small cell lung cancer.\n4. Indication for thoracic radiotherapy, with the esophagus within 1 cm of the PTV.\n5. Prescription dose for the PTV: 60-70 Gy once daily (2 Gy\u002FFx), 45 Gy twice daily (1.5 Gy\u002FFx, with intervals exceeding 6 hours), or 45 Gy once daily (3 Gy\u002FFx).\n6. Ability to orally intake food normally.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n8. The volume of both lungs receiving more than 20 Gy (V20) should not exceed 30% of the total lung volume.\n9. Expected survival of more than 3 months.\n10. Laboratory test results during the screening period:\n\n    Complete blood count: ANC ≥ 1.5 × 10\\^9\u002FL; PLT ≥ 80 × 10\\^9\u002FL; Hb ≥ 90 g\u002FL. Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN; BUN and Cr ≤ 1.5 × ULN, with creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n11. Female subjects of childbearing potential, male subjects, and partners of male subjects agree to use reliable contraceptive methods during the study period (such as abstinence, sterilization, oral contraceptives, or other contraceptive measures).\n\nExclusion Criteria:\n\n1. Previous history of thoracic radiotherapy.\n2. Suspected or confirmed tumor invasion of the esophagus.\n3. Patients with other primary tumors.\n4. History of esophageal cancer, gastric cancer, or prior esophageal surgery.\n5. Concurrent active reflux esophagitis.\n6. Current regular use of immunonutrition (e.g., Oral Impact®).\n7. Patients with severe cardiovascular or cerebrovascular diseases, or comorbidities such as liver or kidney diseases.\n8. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n9. Concurrent active autoimmune diseases requiring treatment.\n10. Known history of human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS).\n11. Any medical (e.g., pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric, or social condition that, in the investigator's judgment, may interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate and participate in the study, or interfere with the evaluation of the study drug, interpretation of patient safety, or study results.",{"count":103,"type":19},121,[105],"PHASE3","This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.",[108,109],"Non Small Cell Lung Cancer","Small Cell Lung Cancer",[111,112,113,114,115],"non-small cell lung cancer","small cell lung cancer","esophagitis","immunonutrition","radiotherapy","RECRUITING","2026-03-28",{"date":119,"type":32},"2026-04-02",{"date":121,"type":32},"2025-02-25",{"date":123,"type":19},"2026-12-30",{"name":38,"class":39},6,{"id":127,"slug":4,"hasResults":10,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":20,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100576646","NCT06788002","LDRT and Chemoimmunotherapy in NPC With Liver Metastasis","Low-dose Radiotherapy and Chemoimmunotherapy in Nasopharyngeal Carcinoma With Liver Metastasis","Light","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 70 years, male or non-pregnant female.\n2. Histologically confirmed with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III)\n3. Stage IVB (AJCC 8th edition staging)\n4. De novo nasopharyngeal carcinoma with liver metastasis, or patients who had received curative treatment (radical radiotherapy or radical radiotherapy combined with chemotherapy) and developed liver metastasis more than 6 months after treatment completion.\n5. ECOG performance status: 0 or 1\n6. Must have at least one measurable lesion (assessed according to RECIST v1.1)\n7. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; platelets ≥ 100 × 10\\^9\u002FL; hemoglobin ≥ 90 g\u002FL.\n8. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n9. Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin.\n10. Serum total bilirubin ≤ 1.5 × ULN (patients with Gilbert's syndrome may be included if total bilirubin \\\u003C 3 × ULN); AST and ALT ≤ 5 × ULN （because of liver metastasis）\n\nExclusion Criteria:\n\n1. Patients with tumor recurrence at the primary site who have previously received radical radiotherapy.\n2. Tumor invasion involving major blood vessels, with a high risk of significant bleeding as assessed by the investigator.\n3. Systemic anticancer therapy, including hormone therapy, administered within 28 days prior to the initiation of the study treatment.\n4. Previous treatment with immune checkpoint inhibitors (e.g., PD-1\u002FPD-L1, CTLA-4).\n5. Patients with active autoimmune diseases or a history of autoimmune diseases with a risk of recurrence.\n6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).\n7. Conditions requiring systemic corticosteroid therapy (equivalent to \\>10 mg\u002Fday of prednisone or similar medications) or other immunosuppressive therapy within ≤14 days prior to treatment.\n8. Uncontrolled diabetes or laboratory abnormalities ≥Grade 1 in potassium, sodium, or corrected calcium levels despite standard treatment, or ≥Grade 3 hypoalbuminemia within ≤14 days before treatment.\n9. History of the following diseases: interstitial lung disease, non-infectious pneumonitis, or uncontrolled diseases, including pulmonary fibrosis or acute lung disease.\n10. Severe chronic or active infections requiring systemic antibiotics, antifungals, or antivirals within ≤14 days before the first dose of the investigational drug (including tuberculosis infection).\n11. Known history of HIV infection.\n12. Untreated chronic hepatitis B patients or hepatitis B virus (HBV) carriers with HBV DNA ≥500 IU\u002FmL, or active hepatitis C virus (HCV) carriers.\n13. Any major surgery requiring general anesthesia within ≤28 days prior to treatment.\n14. Previous allogeneic stem cell transplantation or organ transplantation.\n15. Any cardiovascular risk factors, including: cardiac chest pain that restricts daily instrumental activities ≤28 days before treatment. Symptomatic pulmonary embolism within ≤3 months before treatment. Acute myocardial infarction within ≤6 months before treatment. History of heart failure meeting New York Heart Association (NYHA) Class III or IV within ≤6 months before treatment. Grade ≥2 ventricular arrhythmias within ≤6 months before treatment. History of cerebrovascular accident within ≤6 months before the first dose of the investigational drug.\n16. Evident bleeding tendencies or clinically significant bleeding symptoms ≤28 days prior to randomization, including but not limited to gastrointestinal bleeding, nasal bleeding (excluding epistaxis or retrograde blood-stained nasal discharge), and persistent bleeding disorders or coagulopathy.\n17. Known allergy to any component of the investigational drug or a history of severe hypersensitivity to other monoclonal antibodies.\n18. Peripheral neuropathy of Grade ≥2 as defined by NCI CTCAE v5.0.\n19. Administration of live vaccines within ≤4 weeks prior to treatment.\n20. Underlying medical conditions (including laboratory abnormalities) or alcohol\u002Fdrug abuse or dependency that could impair drug administration, interpretation of drug toxicity, or adverse events (AEs), or could compromise study compliance or execution.\n21. Pregnant or breastfeeding women.\n22. Other factors deemed by the investigator that could lead to the premature termination of the study, such as other severe illnesses, significant laboratory abnormalities, or family\u002Fsocial factors that could affect participant safety or the collection of study data.","70 Years",{"count":135,"type":19},26,[80],"This study aims to evaluate the efficacy and toxicity of adding low-dose radiotherapy to chemoimmunotherapy as a first-line treatment for nasopharyngeal carcinoma patients with liver metastasis.",[139],"Nasopharyngeal Cancinoma (NPC)",[141,142,143,144,145],"nasopharyngeal carcinoma","liver metastasis","low-dose radiotherapy","chemotherapy","immunotherapy",{"date":119,"type":32},{"date":148,"type":32},"2025-01-14",{"date":150,"type":19},"2027-06-30",{"name":38,"class":39},7,{"id":154,"slug":4,"hasResults":10,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":159,"targetDuration":4,"studyType":20,"phases":161,"briefSummary":162,"conditions":163,"keywords":167,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":40},"100617099","NCT07314216","Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcinoma","A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study-specific procedures;\n2. Age 18-75 years;\n3. ECOG performance status of 0 or 1 with no deterioration within the 2 weeks prior to enrollment, and a life expectancy of ≥12 weeks;\n4. Histologically or cytologically confirmed non-squamous non-small cell lung cancer;\n5. Assessed as having unresectable or inoperable locally advanced non-squamous non-small cell lung cancer suitable for definitive radiotherapy (Stage III according to AJCC 9th edition TNM staging);\n6. Presence of EGFR uncommon mutations (excluding 19del, L858R, T790M) confirmed by genetic testing in a tertiary grade A hospital; specific types are detailed in Appendix 11;\n7. No prior systemic anti-tumor therapy or radiotherapy for locally advanced non-small cell lung cancer before the first dose of the study drug, including chemotherapy, biologic therapy, targeted therapy, immunotherapy, or investigational drug therapy;\n8. At least one accurately measurable lesion according to RECIST 1.1, which has not been previously irradiated and was not biopsied during the screening period. If a subject has only one measurable lesion, biopsy of that lesion is permitted, provided the baseline imaging is performed at least 14 days after the biopsy;\n9. Female subjects must use highly effective contraception (see restrictions) for at least 2 weeks prior to the first dose, have a negative pregnancy test, must not be breastfeeding at the time of treatment initiation, OR must meet at least one of the following criteria at screening to demonstrate the absence of childbearing potential;\n\n   * Postmenopausal, defined as age over 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal treatments;\n   * For women aged 50 years or younger, amenorrhea for 12 months or more after cessation of exogenous hormone therapy and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the institutional postmenopausal range;\n   * Irreversible surgical sterilization documented by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but excluding tubal ligation;\n10. Male subjects must be willing to use barrier contraception ;\n11. Ability to comply with the study protocol and follow-up procedures, and capable of oral medication intake\n\nExclusion Criteria:\n\n1. Pathological type is pulmonary squamous cell carcinoma or small cell lung cancer;\n2. Known history of hypersensitivity to the active or inactive excipients of firmonertinib, or to drugs with a similar chemical structure or class to the investigational drug;\n3. Confirmed presence of EGFR exon 19 deletion or exon 21 L858R mutation;\n4. Presence of metastatic disease, or assessed as unsuitable for definitive radiotherapy; or unable to undergo definitive radiotherapy due to extensive tumor volume resulting in normal tissue radiation doses exceeding dose constraints;\n5. NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumor;\n6. Prior to the first dose of the study drug, patients who have received any of the following treatments;\n\n   * Any prior EGFR-TKI therapy;\n   * Patients who have received intrapleural infusion therapy; these patients may be enrolled only after pleural effusion has been stable for 28 days or more;\n   * Major surgery within 28 days prior to the first dose of study drug (In China, major surgery is defined according to the Level 3 and Level 4 surgeries specified in the \"Administrative Measures for the Clinical Application of Medical Technologies\" implemented on May 1, 2009; see Appendix 5 for details);\n   * Treatment with strong CYP3A4 inhibitors or inducers within 7 days prior to the first dose, or patients who require continued use of these drugs during the study period (see Appendix 6 for drug list);\n   * Treatment with traditional Chinese medicine or Chinese patent medicine for anti-tumor indications within 7 days prior to the first dose, or patients who require continued use of these drugs during the study period;\n   * Concurrent use of medications known to prolong the QTc interval or that may induce Torsade de Pointes, and which require continued administration during the study period (see Appendix 8 for drug list);\n   * Discontinuation of other investigational drugs within less than 5 half-lives or 2 months (whichever is longer) prior to the first dose;\n7. Toxicities from prior anti-tumor therapy have not recovered to ≤ CTCAE Grade 1 prior to the first dose of the study drug (except for alopecia or chemotherapy-induced peripheral neuropathy ≤ CTCAE Grade 2);\n8. Patients with unstable pleural effusion;\n9. History of, or diagnosis with, another malignancy within the past 5 years, except for effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast;\n10. Recent active digestive tract diseases, such as duodenal ulcer, ulcerative colitis, ileitis, etc.; intestinal perforation; intestinal fistula; or other conditions deemed by the investigator as potentially leading to gastrointestinal bleeding or perforation; or refractory nausea\u002Fvomiting, chronic gastrointestinal diseases, inability to swallow the study drug, or prior extensive bowel resection that would preclude adequate absorption of firmonertinib;\n11. Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, active bleeding, etc., which in the investigator's judgment is not conducive to the patient's participation in the study or may compromise protocol compliance; or active infection including Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV) (including any patient receiving intravenous treatment for infection; active hepatitis B infection at a minimum includes all patients serologically positive for HBsAg with HBV DNA \\>1000 copies\u002FmL);\n12. History of interstitial lung disease (ILD), drug-induced ILD, prior history of radiation pneumonitis requiring steroid treatment, or any evidence of active ILD;\n13. Any known evidence of corneal lesions\u002Fdamage;\n14. Inadequate bone marrow reserve or organ function based on examinations within 28 days prior to the first dose of study drug (without transfusion or blood products, granulocyte colony-stimulating factor, or other hematopoietic stimulators within 2 weeks prior to testing);\n\n    * Absolute neutrophil count \\\u003C1.5 × 10\\^9\u002FL; Platelet count \\\u003C100 × 10\\^9\u002FL; Hemoglobin \\\u003C90 g\u002FL;\n    * Alanine aminotransferase \\> 2.5 × ULN; Aspartate aminotransferase \\>2.5 × ULN; Total bilirubin \\> 1.5 × ULN, or for patients with liver metastases, AST and\u002For ALT \\>5 × ULN;\n    * Serum creatinine \\>1.5 × ULN, OR Creatinine clearance \\\u003C50 mL\u002Fmin (measured or calculated using the Cockcroft and Gault formula, see Appendix 2);\n    * International Normalized Ratio \\> 1.5, AND Activated Partial Thromboplastin Time \\>1.5 × ULN;\n15. Any of the following cardiac criteria;\n\n    * Mean resting corrected QT interval (QTc) \\>470 msec obtained from 3 consecutive ECGs, calculated using Fridericia's formula;\n    * Any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG within 28 days prior to the first dose, e.g., complete left bundle branch block, third-degree, and second-degree heart block;\n    * Cardiac function assessment within 28 days prior to the first dose: Left Ventricular Ejection Fraction \\\u003C50%; history of myocardial infarction, severe\u002Funstable angina, or coronary artery bypass graft surgery within the past 6 months; or cardiac insufficiency ≥ NYHA Class 2;\n16. Pregnancy or lactation;\n17. Patients judged by the investigator as ineligible for the study, such as those unlikely to comply with the study protocol, procedures, and requirements; or any other circumstances warranting exclusion based on the investigator's discretion",{"count":160,"type":19},15,[80],"This is a prospective, single-arm, Phase II clinical study aimed at evaluating the efficacy and safety of 160mg fimonertinib in combination with definitive radiotherapy for patients with EGFR uncommon driver mutation-positive, Stage III unresectable lung adenocarcinoma. The primary endpoint is Progression-Free Survival (PFS), assessed by the investigator according to RECIST 1.1 criteria, defined as the time from the first dose to objective disease progression or death (from any cause). Secondary endpoints include PFS by different mutation types, OS, ORR, DCR, as well as adverse events and their severity.",[164,165,166],"NSCLC (Non-small Cell Lung Carcinoma)","Stage III","EGFR Uncommon Mutations",[168,169,170,115],"unresectable Stage III lung adenocarcinoma","EGFR uncommon mutations","Firmonertinib","2026-01-03",{"date":173,"type":32},"2026-01-06",{"date":175,"type":19},"2026-01-01",{"date":177,"type":19},"2030-12-31",{"name":38,"class":39},{"id":180,"slug":4,"hasResults":10,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":20,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":40},"100605512","NCT07163481","A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4\u002F6 Inhibitors","A Phase Ib, Open-label, Modular Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4\u002F6 Inhibitors","SoGreat","Inclusion Criteria:Patients must meet the following criteria at screening:\n\n1. Female or male patients, 18 years of age or older, able to understand and give written informed consent.\n2. ECOG performance status of 0 or 1.\n3. Men, pre-menopausal or perimenopausal women must use gonadotropin-releasing hormone agonists (such as goserelin) in a standardized manner.\n4. Postmenopausal women must meet one of the following criteria:\n\n   1. bilateral oophorectomy.\n   2. age 60 years or older.\n   3. age \\\u003C60 years and natural menopause (not induced by medication) for more than 12 months with follicle-stimulating hormone (FSH) and estradiol levels in the postmenopausal range.\n5. Histologically documented breast cancer that:\n\n   1. Is locally advanced inoperable or metastatic recurrence.\n   2. Is documented as HR-positive, HER2-negative (either ER and\u002For PgR positive \\[ER or PgR 1%\\]; HER2 negative \\[IHC 2+\u002FISH-; IHC1+\u002FISH- or untested; IHC 0\u002FISH- or untested\\]) per ASCO\u002FCAP guidelines in the metastatic setting. If a patient has had multiple ER\u002FPgR\u002FHER2 results after metastatic disease, the most recent test result will be used to confirm eligibility.\n6. Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting study treatment.\n7. Must have had disease progression on CDK4\u002F6i combined with endocrine therapy administrated as the first line and the only therapy for metastatic disease. The time till progression (TTP) for the first line CDK4\u002F6 must be no less than 6 months.\n8. Patients who received adjuvant endocrine therapy with or without CDK4\u002F6i with curative intent for early breast cancer are eligible, as long as they relapse after the first 24 months of adjuvant endocrine therapy.\n9. No prior chemotherapy for advanced or metastatic breast cancer. Patients who have received chemotherapy in the neo-adjuvant or adjuvant setting are eligible, as long as they have had a disease-free interval (defined as completion of systemic chemotherapy to the diagnosis of advanced or metastatic disease) of \\>12 months.\n10. Measurable disease by CT or MRI in accordance with RECIST v 1.1, the bone-only disease was not measurable and was not permitted.\n11. Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g\u002FdL, ANC ≥ 1500\u002Fmm 3 , and platelets ≥ 100,000\u002FµL).\n12. Adequate hepatic function (bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN or ≤ 5 × ULN if known liver metastases, and serum albumin \\> 3 g\u002FdL).\n13. Creatinine clearance ≥ 30 mL\u002Fmin as assessed by the Cockcroft-Gault equation\n14. Recovered from all prior treatment-related toxicities to Grade 1 or less by NCI-CTCAE v 5.0 (except alopecia or peripheral neuropathy, which should be Grade 2 or less).\n15. Willing and able to comply with the requirements and restrictions in this protocol.\n\n    \\-\n\nExclusion Criteria: Patients must NOT meet the following criteria at screening:\n\n1. Positive serum pregnancy test or women who are breastfeeding.\n2. Women of childbearing potential or fertile men unwilling to use highly effective contraception during the study and up to 6 months after treatment discontinuation in women of childbearing potential and 3 months in males post last IP administration.\n3. Known hypersensitivity to the study drug, its metabolites, or formulation excipient.\n4. Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 4.2.6.\n5. Have had a prior anticancer biologic agent within 4 weeks prior to enrollment or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (i.e., ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.\n6. Have not recovered (i.e., ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent.\n\n   * Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study.\n   * Note: if patients received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n7. Have previously received treatment with topoisomerase I inhibitors as a free form or as other formulations.\n8. Have previously received treatment in advanced or metastatic setting with systemic therapy before or after the first line CDK4\u002F6i combined with ET, including but not limited to:\n\n   1. chemotherapy.\n   2. endocrine monotherapy or combined with target therapy (PI3Ki, mTORi, AKTi, HDACi, etc.).\n   3. PARPi.\n   4. immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.)\n   5. antibody-drug conjugates.\n9. Have an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n10. Met any of the following criteria for cardiac disease:\n\n    1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment.\n    2. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n    3. New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of \\\u003C 40%.\n11. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n12. Have active serious infection requiring antibiotics.\n13. Have known history of HIV-1 or 2 (or positive HIV-1\u002F2 antibody, if done at screening) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n14. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n\n    * Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n    * Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require an HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n    * Patients who test positive for HIV antibody.\n15. Patients with a history of or current central nervous system (CNS) metastases. A scan to confirm the absence of brain metastases was not required. Patients with unknown CNS metastatic status and any clinical signs indicative of CNS metastases were eligible if CNS metastases were excluded using CT and\u002For MRI scans.\n16. Patients with Gilberts disease.\n17. Known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness present within 6 months of the first dose.\n18. High-dose systemic corticosteroids within 2 weeks prior to the first dose (however, low-dose corticosteroids 10 mg prednisone or equivalent daily were permitted if provided the dose was stable for 4 weeks).\n19. Scheduled surgery during the study, other than minor surgery which would not delay study treatment.\n20. Patients who had received a live vaccine within 30 days of the first dose.\n21. Rapid deterioration during Screening prior to the first dose, e.g., significant change in PS, unstable pain symptoms requiring modifications in analgesic management.\n22. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n23. Any medical condition that, in the investigators or sponsor's opinion, poses an undue risk to the patient's participation in the study.\n\n    \\-",{"count":187,"type":19},12,[189],"PHASE1","SoGreat is an open-label, single-arm, modular, two-stage, Phase Ib\u002FII study. SoGreat (Part 1) is an open-label, modular, Phase Ib study.",[192],"Stage IV (Metastatic) Breast Cancer",[194,195],"Sacituzumab Govitecan","Breast Neoplasms","2025-09-10",{"date":198,"type":32},"2025-09-16",{"date":200,"type":19},"2025-10",{"date":202,"type":19},"2026-12",{"name":38,"class":39},{"id":205,"slug":4,"hasResults":10,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":210,"targetDuration":4,"studyType":20,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":40},"100600479","NCT07098026","Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer","Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer: A Multicenter Randomized Controlled Clinical Study","Inclusion Criteria:\n\n* Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or cytology;\n* Resectable or potentially resectable gastric cancer with clinical stage of cT3-4aN + M0 or cT4bNxM0;\n* Patients who are not allowed to receive previous anti-tumor therapy including chemotherapy radiotherapy immunotherapy or targeted therapy; Adequate organ function defined as follows: hematological ANC ≥ 1.5 \\* 10 \\^ 9\u002FL hemoglobin ≥ 9 g\u002FdL platelets ≥ 80 \\* 10 \\^ 9\u002FL albumin ≥ 30 g\u002FL serum bilirubin ≤ 1.5 × ULN AST and ALT ≤ 2.5 × ULN ALP ≤ 2.5 × ULN TBIL ≤ 1.5 × ULN renal serum creatinine \\\u003C 1.5 × ULN.\n* KPS ≥ 70 points;\n* 18-75 years old male or female;\n* Subjects voluntarily signed a written informed consent form.\n\nExclusion Criteria:\n\n* Associated with distant metastasis;\n* Patients with known hypersensitivity or metabolic disorder to fluorouracil or oxaliplatin or known hypersensitivity or intolerance to the study drug; Patients with primary malignant tumors at other sites. Subjects who were disease-free for 5 years or had a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ were eligible;\n* Gastrointestinal emergencies include: inability to swallow (complete or incomplete) gastrointestinal obstruction gastrointestinal bleeding and gastrointestinal perforation;\n* Patients who are pregnant have neurological diseases or mental illness and mental and language disorders;\n* Known uncontrolled angina pectoris arrhythmia congestive heart failure or myocardial infarction or a history of cardiac insufficiency within 6 months prior to study enrollment;\n* Any concurrent disease or condition that may make the subject unsuitable for study participation or any serious medical condition that may interfere with the subject 's safety;\n* Persons who are incapable (legally) or unsuitable for continuing study treatment for ethical\u002Fmedical reasons.",{"count":211,"type":19},286,[53],"The purpose of this clinical trial is to investigate whether the drug Shenqi Fuwei Mixture is effective for postoperative recurrence and metastasis of gastric cancer. Safety of Shenqi Fuwei Mixture will also be understood. It aims to answer the main questions:\n\n* Shenqi Fuwei Mixture in perioperative combined with neoadjuvant chemotherapy to reduce the recurrence and metastasis of locally advanced gastric cancer after surgery?\n* Shenqi Fuwei Mixture in the prevention and treatment of postoperative recurrence and metastasis of gastric cancer dominant population characteristics and efficacy mechanism?\n* Exploratory excavation of TCM syndrome, multi-omics combined means to explore the advantages of Shenqi Fuwei Mixture on postoperative recurrence and metastasis of gastric cancer? The researchers will compare the drug Shenqi Fuwei Mixture with placebo (a substance that does not contain drugs and has a similar appearance) to see if the drug Shenqi Fuwei Mixture can prevent and treat recurrence and metastasis of gastric cancer after surgery.\n\nParticipants will:\n\n* Take Shenqi Fuwei Mixture or placebo daily, synchronize with chemotherapy, or until tumor progression or intolerable toxicity\n* Visits every 3 weeks for tests and tests\n* Their survival status and adverse drug reactions were recorded",[215],"Gastric Cancer, Adenocarcinoma",[217,218,219,220],"locally advanced gastric cancer","perioperative","neoadjuvant chemotherapy","Shenqi Fuwei Mixture","2025-07-24",{"date":223,"type":32},"2025-08-01",{"date":225,"type":32},"2025-05-01",{"date":227,"type":19},"2028-12-31",{"name":38,"class":39},{"id":230,"slug":4,"hasResults":10,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":20,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":4},"100599376","NCT07083687","Lorlatinib in ROS1+ NSCLC With Brain Metastasis","A Phase 2, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Lorlatinib in TKI naïve, Advanced ROS1-Positive Non-Small Cell Lung Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n1. Age≥18 years old.\n2. Histologically or cytologically confirmed diagnosis of ROS1+ NSCLC with brain metastases before the use of lorlatinib.\n3. ROS1 rearrangement positive confirmed by IHC FISH, PCR, or next generation sequencing (NGS). Patients with other treatable gene mutations besides ROS1 need to submit for discussion with the study experts to determine eligibility.\n4. Treatment naïve or one prior systemic treatment with platinum-based chemotherapy.\n5. Imaging (MR\u002FCT) confirmed untreated brain metastases before lorlatinib initiation;\n6. Participants with asymptomatic brain metastases or currently unrequiring corticosteroid treatment, or on a stable or decreasing dose of ≤10 mg QD prednisone or equivalent can be enrolled.\n7. According to RECIST 1.1, patients must have at least one at least one measurable intracranial target lesion with the long axis greater or equal to 5 mm at baseline.\n8. Eastern Cooperative Oncology Group Performance (ECOG) score of 0-1.\n9. The subject's expected survival time must be 12 weeks or longer.\n10. Participants must have normal primary organ function and meet the following criteria during screening:\n\n（1）No blood transfusions within the past 14 days and Adequate hematopoietic function, defined as follows:\n\na） Hemoglobin \\> 90g\u002FL（without the use of erythropoietin within the past 14 days） b） Absolute Neutrophil Count (ANC) ≥1.5×109\u002FL（without the use of growth factors within the past 14 days） c） Platelets（PLT）≥100×109\u002FL（without the use of platelet-stimulating agents within the past 14 days） （2）Adequate Liver Function, defined as follows：\n\n1. Total serum bilirubin ≤1.5 x upper limit of normal (ULN)\n2. Alanine Aminotransferase（ALT） and Aspartate Aminotransferase（AST）≤3.0 x ULN (≤5.0 x ULN in case of liver metastases) （3）Adequate Renal Function, defined as follows：\n\na） Serum creatinine（Cr）≤1.5× ULN or estimated creatinine clearance（CCr）≥45 ml\u002Fmin （4）Adequate coagulation function, defined as follows：\n\na） International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; PT can be within the predetermined range for the anticoagulant if the participant is currently receiving anticoagulant therapy Adequate Pancreatic Function, defined as serum total amylase≤1.5×ULN； 11.Adequate Pancreatic Function, defined as serum total amylase≤1.5×ULN； For women of childbearing potential (defined as not being postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy), a serum pregnancy test should be conducted within seven days prior to the first administration of the investigational drug, and the result should be negative. All participants (regardless of gender) must agree to use contraceptive measures during the entire treatment period and for at least 90 days after the last dose of the investigational drug.\n\n12.Participants must understand and voluntarily sign the written informed consent form, demonstrate good compliance, adhere to the trial treatment plan and visit schedule, and be able to cooperate in observing adverse events and treatment efficacy.\n\nExclusion Criteria:\n\n1. Have received treatment with the investigational drug or known allergy to the ingredients or excipients of the investigational drug.\n2. Concurrent participation in another clinical study, except for observational (non-interventional) clinical studies or subsequent stages of interventional studies.\n3. Brain metastasis combined with leptomeningeal metastases.\n4. Brain metastasis with bleeding, or the presence of central nervous system complications requiring urgent local intervention (such as surgery, radiotherapy, etc.).\n5. Presence of spinal cord compression unless pain symptoms and neurological function have remained stable or improved 2 weeks prior to enrollment.\n6. Received open surgery (except surgery for biopsy purposes) within ≤14 days prior to enrollment.\n7. Received intracranial radiotherapy before enrollment.\n8. Fever with a temperature above 38℃ within the past week; or clinically significant bacterial, fungal, or viral infection, including but not limited to HIV infection, active HCV infection, active tuberculosis, active hepatitis B (active hepatitis B is defined as HBsAg positive and HBV-DNA copy number exceeds the upper limit of normal in the laboratory of the study center); or infections requiring hospitalization, septicemia, severe pneumonia, etc.\n9. Significant clinical abnormalities in rhythm, conduction, or morphology on resting ECG, such as QT interval (QTc) ≥ 450 ms in males or ≥ 470 ms in females, complete left bundle branch block, 2nd degree or higher heart block, clinically significant ventricular arrhythmia, or atrial fibrillation.\n10. Unstable angina, congestive heart failure (NYHA class III or IV), myocardial infarction, coronary\u002Fperipheral artery bypass, cerebrovascular accident, untreated transient ischemic attack, or symptomatic pulmonary embolism occurring currently or within the past 3 months.\n11. Presence of risk factors for QT interval prolongation or increased risk of arrhythmia, such as grade 2 hypokalemia (grade 2 hypokalemia is defined as: blood potassium \\\u003C normal lower limit -3.0mmol\u002FL, and with symptoms, requiring treatment), congenital long QT syndrome, family history of long QT syndrome.\n12. Past or current clinically active interstitial lung disease; presence of pulmonary interstitial fibrosis or active tuberculosis.\n13. Disorders of swallowing function, active gastrointestinal disease, or other diseases significantly affecting the absorption, distribution, metabolism, and excretion of the investigational drug. History of major gastric resection.\n14. Presence of other acquired, congenital immunodeficiency diseases, or previous solid organ or hematopoietic stem cell transplantation.\n15. Evidence of severe or uncontrolled systemic diseases (such as severe mental, neurological diseases, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension i.e., still being greater than or equal to CTCAE 5.0 grade 3 hypertension after drug treatment).\n16. Diagnosis or treatment of other malignant tumors within the past 5 years (excluding adequately treated basal cell or squamous cell skin cancer, bladder carcinoma in situ, cervical carcinoma in situ, ductal carcinoma in situ, localized prostate cancer).\n17. Use of any known QT-prolonging drugs within 2 weeks before the first dose.\n18. Use or consumption of known potent CYP3A4 inhibitors in medications or food within the past 2 weeks; use of known potent CYP3A4 inducers within the past 2 weeks; use of medications that act as CYP3A4 substrates (with a narrow therapeutic index) within the past 2 weeks.\n19. Severe acute or chronic mental illness, including recent (within the past year) or active suicidal ideation or behavior.\n20. For pregnant or lactating women or male or female participants with reproductive potential, refusal to adopt effective contraceptive measures during the treatment period and for 90 days after the last use of the investigational drug.\n21. The investigator believes that the participant may be unable to complete the study or comply with the study requirements.\n22. The investigator believes that there are other potential risks making the participant unsuitable for this study.",{"count":236,"type":19},21,[80],"The goal of this Phase II, multicenter, open-label, single-arm clinical trial is to evaluate the intracranial efficacy and safety of lorlatinib in adults with TKI-naïve, advanced ROS1-positive non-small cell lung cancer (NSCLC) and untreated brain metastases. The main questions it aims to answer are:\n\nWhat is the intracranial efficacy (eg., objective response rate\u002FPFS) assessed by revised RECIST v1.1?\n\nHow do exploratory biomarkers (e.g., ctDNA dynamics in plasma\u002FCSF) correlate with lorlatinib resistance?\n\nParticipants will:\n\nReceive lorlatinib 100 mg orally once daily until disease progression or unacceptable toxicity.\n\nUndergo brain MRI\u002FCT scans every 8 weeks (first 12 cycles) and every 16 weeks thereafter.\n\nProvide blood samples for safety\u002Fbiomarker analysis and optional CSF samples via lumbar puncture during scheduled visits.",[240],"Lung Cancer (NSCLC)",[111,242,243],"ROS1","lorlatinib","2025-07-16",{"date":221,"type":32},{"date":247,"type":19},"2025-08-15",{"date":249,"type":19},"2028-12-01",{"name":38,"class":39},{"id":252,"slug":4,"hasResults":10,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":260,"conditions":261,"keywords":268,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":40},"100598612","NCT07073755","Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4\u002F6i, PIK3CA Inhibitors, or T-DXd","A Real-World Observational Study on Post-Resistance Treatment Outcomes in Advanced Breast Cancer Patients After CDK4\u002F6 Inhibitors, PIK3CA Inhibitors, or Trastuzumab Deruxtecan Therapy","Inclusion Criteria:\n\n1. Adults (≥18 years old) with histologically or cytologically confirmed advanced or metastatic breast cancer\n2. Received prior treatment with at least one of the following: CDK4\u002F6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted therapies\n3. Documented disease progression following prior targeted therapy\n4. Initiated a subsequent line of systemic therapy (chemotherapy, endocrine therapy, targeted therapy, or combination) after resistance\n5. Available clinical data including baseline characteristics and treatment details\n6. At least one follow-up evaluation after initiation of post-resistance therapy\n\nExclusion Criteria:\n\n1. Incomplete medical records or missing key clinical follow-up data\n2. Concurrent diagnosis of other active malignancies (except non-melanoma skin cancer or in situ cervical cancer)\n3. Known central nervous system disease requiring immediate local treatment (unless clinically stable)\n4. Poor general condition with an Eastern Cooperative Oncology Group (ECOG) performance status ≥2\n5. Life expectancy estimated to be less than 6 months based on clinical judgment",{"count":258,"type":19},200,"OBSERVATIONAL","This is a real-world observational study aiming to evaluate the effectiveness of post-progression treatment strategies in patients with advanced breast cancer who have developed resistance to prior targeted therapies, including CDK4\u002F6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted agents commonly used in clinical practice. As resistance to these therapies becomes increasingly common, optimal sequencing strategies for subsequent treatment remain unclear.\n\nThis study will collect clinical information on post-resistance systemic treatments and their outcomes, including progression-free survival, overall survival, and response rate. Baseline patient and tumor characteristics will also be collected to explore potential prognostic and predictive factors and to develop outcome prediction models that may help guide future clinical decision-making.\n\nThis is a non-interventional study based on retrospective and prospective data from routine medical care. The results are expected to provide real-world evidence to inform personalized treatment strategies for patients with advanced breast cancer following resistance to targeted therapies.",[262,263,264,265,266,267],"Metastatic Breast Cancer","Drug Resistance","Hormone Receptor-Positive Breast Cancer","HER2-positive Breast Cancer","Triple-Negative Breast Cancer (TNBC)","Treatment Decisions",[269,270,271,262,272],"Real-World Study","Treatment Resistance","Post-Progression Therapy","Predictive Factors","2025-07-09",{"date":275,"type":32},"2025-07-18",{"date":277,"type":32},"2023-01-01",{"date":279,"type":19},"2026-06-01",{"name":38,"class":39},{"id":282,"slug":4,"hasResults":10,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":298,"leadSponsor":300,"locationsCount":40},"100518649","NCT06033287","Real-World Study on CDK4\u002F6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+\u002FHER2- MBC.","Observational Real-World Study on the Efficacy, Safety, and Biomarker Exploration of CDK4\u002F6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+\u002FHER2- Metastatic Breast Cancer.","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  * Age ≥ 18 years, postmenopausal or pre\u002Fperimenopausal females, or male patients. Female patients must meet one of the following criteria:\n\n    1. Prior bilateral oophorectomy or age ≥ 60 years.\n    2. Age \\\u003C 60 with natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without any other pathological or physiological reasons), and estradiol (E2) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal range.\n    3. Pre\u002Fperimenopausal females may also be eligible but must be willing to receive LHRH agonist during the study.\n  * Pathologically confirmed HR-positive male\u002Ffemale breast cancer patients with evidence of localized recurrence or metastasis, who are not suitable for curative surgery or radiation therapy:\n\nER-positive and\u002For PR-positive defined as the proportion of positively stained tumor cells ≥ 1% of all tumor cells (as confirmed by the investigators at the participating center).\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* No prior systemic treatment or currently receiving CDK4\u002F6 inhibitors as first-line treatment for advanced disease.\n* Reproductive-age females must have a negative serum pregnancy test within 28 days before enrollment and male\u002Ffemale patients must be willing to use a medically approved highly effective contraceptive measure during the study period and up to 1 year after the last dose of investigational drug.\n* Non-pregnant or non-lactating females.\n* Not concurrently participating in any other ongoing study.\n* Patient or legally authorized representative has provided informed consent and is willing and able to comply with the planned visits, study treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n* 1\\. Any evidence of severe or uncontrolled systemic illnesses, including uncontrolled hypertension, active bleeding disorders, active infections including hepatitis B, hepatitis C, and human immunodeficiency virus, or severely impaired bone marrow reserve or organ function, including liver and kidney impairment, which, in the investigator's opinion, would greatly alter the risk\u002Fbenefit balance.\n* Patient has not yet recovered from any CTCAE grade ≥ 3 toxicity related to prior treatment at the start of CDK4\u002F6 inhibitor therapy.\n* Known history of allergy to CDK4\u002F6 inhibitors, excipients, or drugs with a similar chemical structure or class as CDK4\u002F6 inhibitors.\n* Patients deemed unsuitable for enrollment by the investigator.",{"count":288,"type":19},300,"Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4\u002F6i Progression in the Real World has significant implications. This study is an observational, real-world study. It plans to include over 300 eligible HR+\u002FHER2- metastatic breast cancer patients who are currently receiving or planning to receive endocrine therapy regimens containing CDK4\u002F6 inhibitors. This study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4\u002F6 inhibitors combined with endocrine therapy, based on clinical guideline consensus. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4\u002F6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be chosen by the physician, and the efficacy and safety of subsequent treatment will be evaluated. Additionally, peripheral blood ctDNA testing will be used to assess changes in baseline and progression-related biomarkers, including ESR1, PI3KCA, FGFR1, PTEN, among some patients.",[58,291,292,293],"Endocrine Therapy","CDK4\u002F6 Inhibitors","Subsequent Treatment","2025-07-08",{"date":296,"type":32},"2025-07-11",{"date":277,"type":32},{"date":299,"type":19},"2025-12-31",{"name":38,"class":39},{"id":302,"slug":4,"hasResults":10,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":10,"sex":75,"minAge":16,"maxAge":133,"enrollmentInfo":307,"targetDuration":4,"studyType":20,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":320,"leadSponsor":322,"locationsCount":40},"100480394","NCT05535413","UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases","A Single-arm, Multicenter, Open-labeled Clinical Study of UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n* Patients aged 18 to 70 years\n* With histologically confirmed HER2 negative recurrent and metastatic breast cancer\n* have at least one measurable lesion in the central nervous system (the longest diameter ≥ 10mm)\n* ECOG score (PS) of 0-2\n* According to screening brain MRI, patients with CNS must meet the following conditions:\n\n  1. untreated brain metastases of breast cancer;\n  2. do not need immediate local treatment;\n  3. brain metastases of breast cancer which was treated in the past:\n\n     1. There are no clinical manifestations that have progressed after the previous local treatment of the central nervous system and require immediate local treatment.\n     2. All records related to the treatment of the central nervous system must be provided.\n     3. All toxicities related to the previous anti-tumor treatment of patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy and immunotherapy within 4 weeks before enrollment must be restored to ≤ level 1 (CTCAE v50). However, patients with hair loss of any grade are allowed to be recruited.\n* Blood routine examination was basically normal within 1 week before enrollment.\n* White blood cell count (WBC) ≥ 30 × 109 \u002FL\n* Neutrophil counts (ANC) ≥ 15 × 109\u002FL\n* Platelet count (PLT) ≥ 100 × 109 \u002FL\n* Hemoglobin ≥ 90g\u002Fdl. Patients can receive blood transfusion or erythropoietin treatment to meet this standard.\n* Within 1 week before enrollment, the liver and kidney function tests were basically normal (based on the normal value of the laboratory of each research center).\n* Total bilirubin ≤ 15 × Upper limit of normal value (ULN)\n* Alanine aminotransferase (SGPT \u002F ALT) ≤ 25 x ULN (patients with liver metastasis ≤ 5 × ULN)\n* Glutamic oxaloacetic transaminase (SGOT\u002FAST) ≤ 25 × ULN (patients with liver metastasis ≤ 5 × ULN)\n* Creatinine clearance rate (Ccr) ≥ 60ml\u002Fmin patients\n* With fertility must agree to use effective contraceptive methods during the study period and within 90 days of the last study medication. Before enrollment, the blood or urine pregnancy test must be negative and the\n* Life expectancy \\> 12 weeks.\n* The patient must be able to participate in and follow the treatment and follow-up.\n\nExclusion Criteria:\n\n* Primary or metastatic lesions were HER2 positive (HER2 IHC or FISH positive)\n* Other malignant carcinomas (including primary brain or leptomeningeal related tumors) in the past 5 years, except for the cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* Anti tumor treatment, including chemotherapeutic radical radiotherapy, hormone therapy, biological therapy Immunotherapy or anti-tumor traditional Chinese medicine.\n* Patients who have received surgical operation on major organs (excluding puncture biopsy) or have suffered significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial.\n* Patients with symptomatic peripheral neuropathy with grade evaluation ≥ 2 (CTCAE 5.0), who have previously used anti-microtubule drugs and have serious adverse reactions related to the nervous system of grade 3 or above.\n* Use capecitabine within 6 months before enrollment; No response to capecitabine in the past (including progression during capecitabine treatment, or duration of clinical response after treatment \\\u003C 3 months) or unable to tolerate to capecitabine.\n* For any brain lesions requiring immediate local treatment, such as increased lesion size or treatment-related edema at intracranial (but not limited to) anatomical sites may pose risks to patients (e.g., brainstem lesions)\n* Known or suspected leptomeningeal disease (LMD)\n* Other non malignant systemic diseases (cardiovascular, renal, liver, etc.) that are excluded from any treatment regimen or interfere with follow-up in pregnant or lactating women.\n* Known or suspected allergy to any study drug or accessories.\n* Brain MRI can not be performed for any other reason.\n* The investigator considers it inappropriate to participate in.\n* Other situations where corticosteroids are prohibited.",{"count":308,"type":19},30,[189,80],"This study is a single-arm, multicenter, open-labeled clinical study of UTD1 combined with Capecitabine in metastatic HER2-negative breast cancaner patients with brain metastases. This study aims to evaluate the efficacy and safety of UDT1 combined with capecitabine in metastatic HER2-negative breast cancer patients with brain metastases.",[312,313,314,315],"Metastatic HER2 Negative Breast Carcinoma","Brain Metastases","Capecitabine","UDT1","2025-04-23",{"date":318,"type":32},"2025-04-25",{"date":277,"type":32},{"date":321,"type":19},"2025-07",{"name":38,"class":39},{"id":324,"slug":4,"hasResults":10,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":133,"enrollmentInfo":330,"targetDuration":4,"studyType":20,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":40},"100573939","NCT06752798","Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC","Bone Marrow Protective Effect of Trilaciclib in Postoperative Concurrent Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: An Open-Label, Single-Arm, Phase 2 Clinical Study","CCRT，LA-HNSCC","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to be enrolled in this study:\n\n  * Pathologically or histologically confirmed locally advanced squamous cell carcinoma of the head and neck (this study includes cancers of the oral cavity, oropharynx, hypopharynx, and larynx, excluding cancers of the lip and nasopharynx).\n  * Indications for surgery and postoperative chemotherapy plus radiotherapy, and meeting the following conditions:\n* (1) Staging of T1-4N0-3M0, having undergone radical surgery;\n* (2) At least one of the following factors: positive surgical margin, tumor close to the surgical margin, postoperative pathological staging pT3-4 or pN2-3, positive lymph nodes in neck level IV or V, tumor invasion of nerves\u002Fblood vessels\u002Flymphatic vessels.\n\n  * ECOG performance status score of 0-1.\n  * Normal major organ function, meeting the following criteria:\n* (1) Hematology standards (no blood transfusion or blood products within 14 days): a. HB ≥ 90 g\u002FL; b. Neu ≥ 1.5×10\\^9\u002FL; c. PLT ≥ 100×10\\^9\u002FL;\n* (2) Biochemical criteria: a. TBIL \\\u003C 1.5× upper limit of normal (ULN); b. ALT and AST \\\u003C 2.5× ULN; c. Serum Cr ≤ 1.0× ULN or creatinine clearance rate \\> 60 ml\u002Fmin.\n\n  * Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use reliable contraception during the study and for a specified period after the last dose of the study drug.\n  * Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of the study drug. For male participants, they must agree to use appropriate contraceptive methods during the study and for 8 weeks after the last dose of the study drug or have undergone surgical sterilization.\n  * The subjects voluntarily join this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Pathologically confirmed non-squamous cell carcinoma.\n* Patients with recurrence or distant metastasis (M1).\n* Previous chemotherapy for any reason, or prior surgery, radiotherapy, molecular targeted therapy, or immune checkpoint inhibitor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, etc.) in the head and neck region.\n* Pregnant or breastfeeding women.\n* Previous or concurrent other malignancies.\n* Patients with other uncontrolled serious diseases.\n* Abnormal function of vital organs such as the heart, brain, or lungs: Hypertension that cannot be controlled to normal range with antihypertensive drugs (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90mmHg); Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia, and Grade II heart failure; stroke or cardiovascular events within 6 months prior to enrollment; abnormal coagulation function (INR \\> 1.5 or prothrombin time (PT) \\> ULN + 4 seconds or APTT \\> 1.5 ULN), with a tendency to bleed or receiving thrombolytic or anticoagulant therapy; clear tendency to bleed; patients with positive proteinuria (urine protein test 2+ or above, or 24-hour urine protein quantification \\> 1.0 g).\n* Active infections requiring systemic treatment, such as tuberculosis.\n* Previous hematopoietic stem cell or bone marrow transplant.\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive).\n* Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria are eligible: HBV viral load must be \\\u003C 1000 copies\u002Fml (200 IU\u002Fml) before the first dose, and subjects should receive anti-HBV therapy throughout the study chemotherapy to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary; active HCV infection subjects (HCV antibody positive and HCV-RNA levels above the detection limit).\n* History of substance abuse that cannot be abstained from or mental disorders.\n* Allergy to the study drug or its components.\n* Any other conditions that the investigator judges may affect the conduct of the clinical study and the determination of the study results.\n* Concurrent participation in another therapeutic clinical study.",{"count":308,"type":19},[80],"To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery",[334],"Head and Neck Cancer Squamous Cell Carcinoma",[336,337,338,339],"Trilaciclib","Head and neck cancer","Adjuvant treatment","chemoradiotherapy","2024-12-29",{"date":342,"type":32},"2024-12-31",{"date":344,"type":19},"2024-12-30",{"date":346,"type":19},"2025-12-30",{"name":38,"class":39},{"id":349,"slug":4,"hasResults":10,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":10,"sex":75,"minAge":16,"maxAge":76,"enrollmentInfo":354,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":365,"locationsCount":40},"100572535","NCT06734533","Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .","A New Option for Post-CDK4\u002F6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4\u002F6is.","Inclusion Criteria:\n\n* Female patients aged 18 to 75 years, with an ECOG score of 0-1, and an expected survival of at least 3 months;\n* Presence of measurable lesions as defined by RECIST 1.1 criteria;\n* Histopathologically confirmed HR-positive\u002FHER2-negative breast cancer. HER2 negativity is determined by an immunohistochemistry (IHC) result of HER2 (0\u002F1+). If the result is HER2 (++), a FISH or CISH test is required to confirm the absence of HER2 amplification;\n* Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options;\n* Prior treatment with at least one line of CDK4\u002F6 inhibitors and endocrine therapy;\n* Disease progression following aromatase inhibitor (AI) or fulvestrant combined with CDK4\u002F6 inhibitors, either as adjuvant therapy or as systemic treatment for advanced disease.\n\nExclusion Criteria:\n\n* Patients with HER2-positive breast cancer confirmed by histology or cytology;\n* Patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors;\n* Detection of a second primary malignant tumor at the time of enrollment;\n* Failure to complete CDK4\u002F6 inhibitor therapy;\n* Pregnant or breastfeeding patients;\n* Presence of third-space fluid accumulation (e.g., pleural effusion, ascites, pericardial effusion) that cannot be managed through drainage or other methods;\n* Patients previously treated with anti-angiogenic agents, including small molecules such as anlotinib or apatinib, and large molecules such as bevacizumab;\n* Patients currently receiving any other anti-tumor treatment for any other malignancies.",{"count":355,"type":19},80,"Cyclin-dependent kinases 4 and 6 (CDK4\u002F6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4\u002F6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4\u002F6 inhibitor.",[358],"HR+ Breast Cancer","2024-12-13",{"date":361,"type":32},"2024-12-16",{"date":363,"type":19},"2024-12-05",{"date":346,"type":19},{"name":38,"class":39},{"id":367,"slug":4,"hasResults":10,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":372,"targetDuration":4,"studyType":20,"phases":374,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":4},"100553473","NCT06486545","Liposomal Irinotecan Combination Regimen for Second-line Treatment of Advanced Gastric Cancer","Liposomal Irinotecan Combined With Albumin-bound Paclitaxel for Second-line Treatment of Advanced Gastric Cancer: a Single-arm, Single-center Clinical Study","Inclusion Criteria:\n\n* Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF)\n* Age ≥18 years\n* The expected survival time is ≥3 months\n* Patients with histologically or pathologically confirmed unresectable or locally advanced gastric cancer and gastro-oesophageal junction adenocarcinoma\n* Patients who have progressed after previous first-line treatment based on fluorouracil\n* HER-2+ is known to have been previously trastuzumab or HER-2 negative\n* According to RECIST1.1 criteria, the patient had at least one measurable target lesion\n* Eastern Cooperative Oncology Group（ECOG）Physical status score: 0-2\n* Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, and hemoglobin ≥90 g\u002FL\n* Serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal (≤3 times the upper limit of normal for patients with liver invasion)\n* There are no contraindications for the use of liposomal irinotecan and albumin paclitaxel\n* Women of childbearing age must have had a pregnancy test (serological) negative within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial\n* Agree to provide histological samples\n\nExclusion Criteria:\n\n* Allergic reaction to any investigational drug or its ingredients\n* Patients with relapse within 6 months after previous first-line treatment with paclitaxel\n* The investigational agent was a CYP3A4 strong inducer within 2 weeks prior to initial administration, or a CYP3A4 strong depressant or UGT1A1 strong depressant within 1 week\n* Uncontrolled systemic diseases (e.g. advanced infections, uncontrolled hypertension, diabetes, etc.)\n* Imaging confirmed intestinal obstruction\n* It has uncontrollable ascites, abdominal infection and pyloric obstruction\n* Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x103 copies \u002FmL; more than 1x103 copies \u002FmL of HCV RNA)\n* Human immunodeficiency virus (HIV) infection (HIV antibody positive)\n* Previous or current co-occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast\u002Fcervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years)\n* Pregnant and lactating women and patients of childbearing age who do not want to use contraception\n* The investigators determined that patients were not suitable to participate in this study",{"count":373,"type":19},18,[53],"Liposomal irinotecan, intravenous infusion 90min, d1:\n\nGrade 1:50mg\u002Fm2 Grade 2:60mg\u002Fm2 Grade 3:70mg\u002Fm2 Albumin-paclitaxel, 150mg\u002Fm2, intravenous infusion, d1 DLT was observed for 2 weeks (the first cycle). The same subject received only one dose of liposomal irinotecan during the study. All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy. If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks, the subject may continue to receive treatment for metastatic disease. The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed. Until there is a possibility of surgery, disease progression, intolerable toxicity or the patient withdraws informed consent (whichever comes first).",[377],"Advanced Gastric Cancer",[379,380,381,382,383],"Gastric cancer and gastroesophageal junction adenocarcinoma","Liposomal irinotecan","Albumin-paclitaxel","Second-line treatment","Dose escalation","2024-08-23",{"date":386,"type":32},"2024-08-26",{"date":388,"type":19},"2024-08-25",{"date":390,"type":19},"2026-01-30",{"name":38,"class":39},{"id":393,"slug":4,"hasResults":10,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":47,"sex":15,"minAge":16,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":411,"locationsCount":40},"100558935","NCT06557590","18F-FAPI-04 PET\u002FCT and PET\u002FMR in Patients With Various Types of Malignant Tumors","Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET\u002FCT and PET\u002FMR in Patients With Various Types of Malignant Tumors","Inclusion Criteria:\n\npatients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\npatients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.","90 Years",{"count":400,"type":19},500,"To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and positron emission tomography\u002Fmagnetic resonance imaging （PET\u002FMR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.",[403,404],"Cancer","FAP","2024-08-14",{"date":407,"type":32},"2024-08-16",{"date":409,"type":32},"2024-01-01",{"date":227,"type":19},{"name":38,"class":39},{"id":413,"slug":4,"hasResults":10,"nctId":414,"briefTitle":415,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":398,"enrollmentInfo":417,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":425,"leadSponsor":426,"locationsCount":40},"100557822","NCT06543108","Preliminary Study on the Diagnostic Value Comparison of 18F-FAPI-04 PET\u002FCT and PET\u002FMR in Gastric Cancer","Inclusion Criteria:\n\n1. Age over 18 years old;\n2. Diagnosed as a patient with gastric cancer;\n3. Receive FAPI PET\u002FCT and FDG PET\u002FCT imaging within one week;\n4. Perform serum tumor marker testing one week before and after scanning\n\nExclusion Criteria:\n\n1. History of other malignant tumors;\n2. Patients with severe infections, severe underlying diseases such as heart, kidney, and liver;\n3. Patients with contraindications for PET-CT examination, poor physical condition, and inability to tolerate the examination;\n4. Patients with unorganized pathology or incomplete clinical data",{"count":308,"type":19},"This project aims to comprehensively analyze the diagnostic efficacy of SUVmax, SUVean, TLG, MTV, etc. in gastric cancer through 18F-FAPI-04 PET\u002FCT imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; Next, analyze the diagnostic efficacy of 18F-FAPI-04 PET\u002FCT and PET\u002FMR multimodal imaging in evaluating SUVmax, PET\u002FCT-PCI, and PET\u002FMR-PCI for gastric cancer peritoneal metastasis, and construct a molecular imaging diagnostic model for gastric cancer peritoneal metastasis; Exploring the clinical value of 18F-FAPI-04 PET\u002FCT and PET\u002FMR imaging in the diagnosis and staging of gastric cancer.",[420],"Gastric Cancer","2024-08-03",{"date":423,"type":32},"2024-08-07",{"date":409,"type":32},{"date":227,"type":19},{"name":38,"class":39},{"id":428,"slug":4,"hasResults":10,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":432,"targetDuration":4,"studyType":20,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":40},"100547335","NCT06406634","Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. The written informed consent form should be signed before a subject participates in the trial；\n2. Histologically\u002Fcytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by the American Association for the Study of Liver Diseases (AASLD)；\n3. According to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 edition), eligible for China liver cancer staging (CNLC) Stage IIIa and is not suitable for radical treatment, such as resection, ablation, or liver transplantation. Suitable for HAIC surgery and chemotherapy drugs prescribed in advance by the research center, without any contraindications to HAIC surgery and chemotherapy drugs；\n4. Child-Pugh A or B；\n5. at least 1 measurable lesion according to RECIST v1.1；\n6. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1；\n7. Adequate organ and marrow function, as defined below； 1) Absolute neutrophil count (ANC) ≥1.5x109\u002FL without granulocyte colony-stimulating factor in the last 14 days； 2) Platelets ≥75×109\u002FL without transfusion in the last 14 days； 3) Hemoglobin ≥8.5 g\u002FdL without transfusion or erythropoietin use in the last 14 days； 4) Serum total bilirubin (TBL) ≤2 × ULN； 5) AST and ALT ≤5× ULN； 6) Serum creatinine ≤1.5 × upper limit of normal (ULN)； Urine protein ≤(++) , or 24-hour urine protein quantification less than 1 g； 7) Good coagulation, defined as the international normalized ratio (INR) ≤ 2， or activated partial prothrombin time (PT) ≤ 1.5 times ULN；\n8. a woman of childbearing potential (WOCBP) who is sexually active with a nonsterilized male partner must have a negative pregnancy test at the Screening visit (within 3 days before the first dose of the investigational product \\[Cycle 1 Day 1\\]). If a negative urine pregnancy test result cannot be confirmed, a blood pregnancy test will be requested. Females not of childbearing age were defined as being at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy；\n9. If there is a risk of conception, all subjects (male or female) will be required to use contraception with an annual failure rate of less than 1% for the entire treatment period up to 120 days after administration of the study drug at the end of treatment；\n\nExclusion Criteria:\n\n1. Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology\u002Fcytology;\n2. Recurrence of previous hepatocellular carcinoma；\n3. Autoimmune hepatitis (requires liver puncture)\n4. Have a history of hepatic encephalopathy or liver transplantation;\n5. Diffuse liver cancer;\n6. Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage;\n7. History of kidney disease or nephrotic syndrome;\n8. Presence of bleeding events from esophageal or gastric varices caused by portal hypertension within the past 6 months. Presence of known severe (G3) varicose veins in endoscopy within 3 months before the first dose. Evidence of portal hypertension (including the finding of splenomegaly in imaging studies) with a high risk of bleeding assessed by the investigator;\n9. Any arterial\u002Fvenous thromboembolic events within 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis, or any other history of serious thromboembolism. Presence of implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, barring stable thrombosis following the conventional anticoagulation treatment. Prophylactic use of low-dose low-molecular-weight heparin is permitted;\n10. Presence of any life-threatening bleeding events;\n11. consecutive dosing of aspirin or other drugs, e.g., dipyridamole and clopidogrel, known to inhibit the platelet function before the first dose;\n12. Uncontrolled hypertension (systolic greater than 140 mmHg or diastolic greater than 90 mmHg) after the optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.\n13. Symptomatic congestive cardiac failure (NYHA Class II-IV). Symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected Qtc \\> 500 ms (calculated using Fridericia formula) during screening.\n14. History of gastrointestinal perforation and\u002For fistula, history of bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection accompanied with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within the past 6 months.\n15. Receipt of major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose or having unhealed wounds, ulcers, or fractures. Receipt of tissue biopsy or other minor surgeries within 7 days before the first dose, barring venipuncture and catheterization for intravenous infusion.\n16. History or current experience of pulmonary fibrosis and such lung diseases as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severely impaired lung function.\n17. Acute or chronic active hepatitis B or C infection\n18. Active tuberculosis (TB), currently receiving anti-tuberculosis treatment or received such therapy within 1 year before the first dose.\n19. Human immunodeficiency virus (HIV) infected (HIV 1\u002F2 antibody positive) and known syphilis infection requiring treatment.\n20. Active or poorly clinically controlled serious infections. Severe infections within 4 weeks before the first dose, including but not limited to hospitalization caused by infection, bacteremia, or severe pneumonia complication.\n21. Receipt of immunosuppressants within 4 weeks before the first dose;\n22. Receipt of a live attenuated vaccine within 4 weeks before the first dose or planned to receive a live attenuated vaccine during the study;\n23. Receipt of systemic treatment with traditional Chinese medicines with cancer indications or immunomodulators (including thymosin, interferon, and interleukin, barring local use for controlling pleural fluid or ascites) within 2 weeks before the first dose;\n24. Prior exposure to any agent targeting T cell costimulation or immune checkpoint pathways (e.g., anti-PD 1, anti-PD L1, anti-PD L2, anti-CTLA 4, anti CD137 or anti-OX40 antibody, etc).\n25. Known allergy or reaction to any component of the Cadonilimab formulation;\n26. Receipt of treatment in other clinical trials within 4 weeks before the first dose;\n27. Pregnant or breastfeeding female patients;\n28. Considered ineligible for participating in the trial by the investigator.",{"count":308,"type":19},[80],"This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma",[436],"Hepatocellular Carcinoma",[438,439,440,441],"Cadonilimab","Lenvatinib","Hepatic Arterial Infusion Chemotherapy (HAIC)","Unresectable Hepatocellular Carcinoma","2024-05-07",{"date":444,"type":32},"2024-05-09",{"date":446,"type":19},"2024-05-15",{"date":448,"type":19},"2027-04-20",{"name":38,"class":39},{"id":451,"slug":4,"hasResults":10,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":10,"sex":75,"minAge":16,"maxAge":133,"enrollmentInfo":456,"targetDuration":4,"studyType":20,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":40},"100545752","NCT06385990","Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy","Clinical Study of the Efficacy and Safety of Utidelone (UTD1) Combined With Capecitabine as Adjuvant Therapy in Non-pCR Triple-negative Breast Cancer Patients After Neoadjuvant Therapy","Inclusion Criteria:\n\n* Signed informed consent;\n* 18 Years and older;\n* Female;\n* Breast cancer confirmed by pathological histology, ER-negative (\\\u003C1% positive), PR-negative (\\\u003C1% positive), and HER2-negative (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification;\n* Patients must receive full course of neoadjuvant chemotherapy before surgery and did not achieve pathological complete response (i. e., pathologically confirmed residual lesion, maximum diameter of 1cm) or \u002F lymph node positive (ypN+);\n* Previous neoadjuvant chemotherapy regimen included anthracycline, taxane, or a combination of both.\n* Patients who clinically require radiotherapy of the affected breast or chest wall and regional lymph node area should receive radiotherapy before or after study medication;\n* All toxicities related to previous antitumor therapy must return to Grade 1 (CTCAE v5.0), except alopecia;\n* Within 1 week before enrollment, the blood routine examination was basically normal (taking the normal value of each study center as the standard): 1) Blood routine: hemoglobin (Hb) \\> 90g \u002F L, White blood cell count (WBC) \\> 3.5\\*10\\^9 \u002F L, Number of neutrophils (ANC) \\* 1.5\\*10\\^9 \u002F L, Platelet count (PLT)\\* 100\\*10\\^9 \u002F L; 2) Renal function: upper limit of normal serum creatinine value; 3) Liver function: for patients without liver metastasis: glutamulate aminotransferase (AST), glutamate aminotransferase (ALT), alkaline phosphatase (ALP) are less than 2.5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value; for patients with liver metastasis, AST, ALT, ALP, ALT, ALP, are less than 5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value;\n* The ECOG physical status score for patients must be 0 or 1;\n\nExclusion Criteria:\n\n* Metastatic breast cancer at diagnosis;\n* Breast cancer patients who did not completed surgery;\n* History of other malignancies within 5 years prior to randomization, but patients with the following tumors may participate in the study: carcinoma of the cervix in situ, colon in situ, melanoma in situ and basal cell carcinoma of the skin and squamous cell carcinoma;\n* Any other non-malignant systemic disease (cardiovascular, renal, liver, etc.) that hinders the implementation or follow-up of the treatment program;\n* Symptomatic congestive heart failure (New York Heart Association Grade II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or corrected QTc\\> 500ms at screening, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy;\n* History of interstitial pneumonia, Need for steroids or evidence of active pneumonia;\n* Suffering from an active autoimmune disease, and required systemic treatment in the past 2 years (i. e., use of disease regulators, corticosteroids, or immunosuppressive drugs);\n* Patients with a known infection with human immunodeficiency virus (HIV);\n* Patients with active infections requiring systemic treatment;\n* Any hormonal medication (such as raloxifene, tamoxifen, or other selective oestrogen receptor modulators) for osteoporosis or breast cancer prophylaxis (only patients who have discontinued these drugs before randomization may participate in the study);\n* The patient received either capecitabine or utiderone before surgery;\n* Pregnant or lactating women;\n* Known or suspected allergy to any study drug or excipients;\n* Prohibition of corticosteroids;\n* Any other condition the investigator considers inappropriate to participate in the trial.",{"count":457,"type":19},53,[80],"This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.\n\nSolution: UTD1 30mg \u002F m², once a day on days 1-5; capecitabine: 1000mg \u002F m², days 1-14, oral, twice \u002F day; 21 days a treatment cycle of 6-8 cycles.",[461],"Triple Negative Breast Neoplasms",[463,464],"adjuvant chemotherapy","non-pCR","2024-04-23",{"date":467,"type":32},"2024-04-26",{"date":469,"type":32},"2024-03-29",{"date":471,"type":19},"2027-03-29",{"name":38,"class":39},{"id":474,"slug":4,"hasResults":10,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":479,"targetDuration":4,"studyType":20,"phases":480,"briefSummary":481,"conditions":482,"keywords":484,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":493,"leadSponsor":495,"locationsCount":4},"100541272","NCT06327698","Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure","Efficacy and Safety of Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure: A Single-arm, Open-label, Multicenter Phase II Clinical Study","Inclusion Criteria:\n\n1. Age \\>18 years and ≤ 75 years\n2. Has a histologically confrmed diagnosis of malignant melanoma\n3. Previously received failed first-line treatment for melanoma\n4. Patients may have a history of liver metastases, but the metastases should be less than 3\n5. Patients with treatment-asymptomatic brain metastases may be included, must be free of disease progression on computed tomography (CT) or magnetic resonance imaging (MRI), stable for at least 3 months, and free of steroid medication for at least 4 weeks\n6. Those with at least 1 measurable lesion (RECIST version 1.1)\n7. ECOG 0-1\n8. Non-lactating patients\n9. Good organ function\n\nExclusion Criteria:\n\n1. Previous (within 5 years) or concurrent other malignant tumors, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer without recurrence \\> 3 years after radical resection\n2. Has an active or potentially recurrent autoimmune disease\n3. History of severe allergic reaction to any monoclonal antibody and\u002For component of the study drug\n4. Known presence of active tuberculosis TB\n5. Currently receiving cancer treatment (chemotherapy, radiotherapy, immunotherapy, or biologic therapy)\n6. Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study\n7. Known history of psychiatric illness, substance abuse, alcoholism, or drug abuse",{"count":308,"type":19},[80],"This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.",[483],"Melanoma",[485,486,487,488],"locally advanced or metastatic melanoma","cadonilimab","anlotinib","First-Line Therapy Failure","2024-03-18",{"date":491,"type":32},"2024-03-25",{"date":446,"type":19},{"date":494,"type":19},"2027-05-31",{"name":38,"class":39},{"id":497,"slug":4,"hasResults":10,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":40},"100540830","NCT06321939","Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Newly diagnosed, pathologically proven World Health Organization (WHO) type II\u002FIII untreated NPC;\n2. Non-metastatic NPC (I-IVA, according to the 8th edition of the AJCC\u002FUICC clinical staging system);\n3. Age at diagnosis: over 18 years old;\n4. Eastern Cooperative Oncology Group (ECOG) score: 0-1\n5. Receiving recommended curative intention treatments：definitive radiotherapy w\u002Fwo three cycles of induction chemotherapy (IC) (gemcitabine-cisplatin \\[GP\\] or paclitaxel-cisplatin \\[TP\\] regimen);\n6. Pre-treatment and post-IC1 cell-free Epstein-Barr virus (cfEBV) DNA \\> 0 copy\u002FmL; systemic cfEBV DNA monitoring during IC phase for risk stratification;\n7. Normal hematic, liver, and kidney function: hemoglobin (HG) \\> 90 g\u002FL; neutrophil \\> 1.5 × 109\u002FL; platelet \\> 100 × 109\u002FL; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance (Ccr) ≥ 60 mL\u002Fmin;\n8. Female subjects capable of becoming pregnant agree to use reliable contraceptive measures from screening to 1 year after treatment;\n9. Patients will be required to sign informed consent forms and be willing and able to comply with the requirements for visits, treatment, laboratory tests, and other research requirements stipulated in the research schedule.\n\nExclusion Criteria:\n\n1. Receiving surgery, target therapy, and\u002For immunotherapy during or before induction phase;\n2. Other previous or concurrent malignant tumors, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary cancer;\n3. Pregnant or lactating women (a pregnancy test should be considered for fertile women with an active sex life);\n4. Previously treated with radical radiotherapy (RT), except non-melanoma skin cancers outside intended RT treatment volume;\n5. Uncontrolled heart disease, e.g.: 1) Heart failure, New York Heart Association (NYHA) level ≥ 2; 2) unstable angina; 3) myocardial infarction in the past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.",{"count":502,"type":19},50,"The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.",[505,506],"Nasopharyngeal Carcinoma","Herpesvirus 4, Human","2024-03-14",{"date":509,"type":32},"2024-03-20",{"date":511,"type":32},"2024-01-11",{"date":227,"type":19},{"name":38,"class":39},{"id":515,"slug":4,"hasResults":10,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":520,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":522,"conditions":523,"keywords":525,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":4},"100514569","NCT05980208","A Real-world Study of Inetetamab for First-line Treatment of MBC","A Real-world Study of Inetetamab for First-line Treatment of HER2-positive Inoperable Locally Advanced or Relapsed Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients aged ≥18 years and ≤75 years;Patients aged ≥18 years and ≤75 years;\n* Her2-positive invasive breast cancer confirmed by pathological examination met the following conditions:\n\nPositive HER2 expression: Immunohistochemical staining (IHC) showed positive HER2 3+ and\u002For fluorescence in situ hybridization (FISH); Tumor staging: inoperable locally advanced or recurrent metastatic breast cancer; Patients with local recurrence must be confirmed by the investigator to be unable to undergo radical surgical excision.\n\n* At least one measurable lesion was present according to RECIST1.1 criteria;\n* The ECOG score is 0 to 1;\n* No systematic antitumor therapy (except first-line endocrine therapy) has been received at the locally advanced stage (clinically inoperable) or at the stage of recurrence and metastasis;\n* The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocyte enhancing and platelet enhancing drugs) :\n\n  1. Blood routine: neutrophils (ANC) ≥1.5×109\u002FL; Platelet count (PLT) ≥90×109\u002FL; Hemoglobin (Hb) ≥90 g\u002FL;\n  2. Blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal value (ULN), known patients with Gilbert syndrome, TBIL≤2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN, patients with liver metastasis required ALT and AST≤5×ULN; Alkaline phosphatase ≤2.5×ULN; Urea\u002Furea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;\n  3. Cardiac ultrasound: left ventricular ejection fraction (LVEF) ≥50%;\n  4. 12-lead electrocardiogram: Fridericia corrected QT interval (QTcF) \\\u003C470 msec;\n* Expected survival ≥3 months;\n* Participate in this study voluntarily, sign informed consent, have good compliance and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Known allergic history of drug components of the program;\n* Patients judged unsuitable for systematic chemotherapy by researchers;\n* Use of endocrine therapy drugs within 14 days before baseline;\n* Patients with only bone or skin as target lesions;\n* Other malignancies, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, within the previous 5 years;\n* Peripheral neuropathy ≥ grade 3 according to CTCAE 5.0 criteria;\n* Had received major surgical procedures or significant trauma within 4 weeks prior to randomization, or was expected to receive major surgical treatment;\n* Serious heart disease or discomfort, including but not limited to:\n\nheart failure or contraction dysfunction (LVEF \\\u003C50%) past medical history high risk or the need for treatment of angina or arrhythmia (such as second degree atrioventricular block type 2 or 3 degree atrioventricular block, ventricular tachycardia) clinical significance of heart valve disease ECG showed wall permeability myocardial infarction poorly controlled hypertension, systolic blood pressure\\>150 mmHg and\u002For diastolic blood pressure\\>100 mmHg\n\n* Dysphagia, chronic diarrhea, intestinal obstruction and other factors affecting drug delivery and absorption;\n* A history of immunodeficiency, including HIV infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;\n* Participated in other drug clinical studies within 4 weeks prior to screening;\n* There is a third interstitial effusion (such as pleural fluid and ascites) that cannot be controlled by drainage or other methods;\n* Pregnant or lactating women, women of childbearing age who are unable to take effective contraceptive measures throughout the trial period;\n* Have a serious concomitant disease or other co-medical condition that interferes with planned treatment or any other condition that is not suitable for participation in the study, such as active hepatitis B, lung infection requiring treatment, etc.",{"count":521,"type":19},150,"This is a prospective, multicenter, real-world study aimed at evaluating the efficacy and safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally advanced or recurrent metastatic breast cancer. The research results will provide new targeted treatment strategies for HER2 positive breast cancer patients.",[58,524],"Real-world Study",[526,527,528,529],"breast cancer","real-world study","HER2-postive","inetetamab","2023-08-06",{"date":532,"type":32},"2023-08-08",{"date":534,"type":19},"2023-09-01",{"date":536,"type":19},"2026-12-31",{"name":38,"class":39},{"id":539,"slug":4,"hasResults":10,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":544,"targetDuration":4,"studyType":20,"phases":546,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":558,"locationsCount":40},"100511522","NCT05940532","A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC","A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1.18 to 75 years old, both male and female;\n\n2.ECOG score: 0-1;\n\n3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;\n\n4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;\n\n5.Measurable lesions available;\n\n6.Major organ function is basically normal;\n\n7.Estimated survival time is at least 6 months;\n\n8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed SCLC and NSCLC;\n2. Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);\n3. Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;\n4. Previous thoracic radiotherapy;\n5. Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;\n6. Systemic immunostimulant therapy before the first dose;\n7. Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;\n8. Subjects with autoimmune diseases;\n9. Other malignant tumors other than non-small cell lung cancer within 5 years before screening;\n10. Known or suspected interstitial pneumonia;\n11. Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;\n12. Severe cardiovascular and cerebrovascular diseases;\n13. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;\n14. Arteriovenous thrombotic events within 3 months before the first dose;\n15. Positive HIV test;\n16. Active hepatitis B or C;\n17. Evidence of active tuberculosis infection within 1 year before the first dose;\n18. Serious infection within 4 weeks before the first dose;\n19. History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;\n20. Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;\n21. Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;\n22. History of severe allergic reactions to other monoclonal antibodies\u002Ffusion proteins;\n23. Allergic to any component of the randomized treatment regimen;\n24. Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;\n25. Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;\n26. Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.",{"count":545,"type":19},41,[80],"The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.",[549],"Carcinoma, Non-Small-Cell Lung",[145,144,115,551,111],"surgery","2023-07-07",{"date":554,"type":32},"2023-07-11",{"date":556,"type":32},"2023-06-14",{"date":202,"type":19},{"name":38,"class":39},{"id":560,"slug":4,"hasResults":10,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":10,"sex":75,"minAge":16,"maxAge":76,"enrollmentInfo":565,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":40},"100464330","NCT05326295","Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients","Surveillance of Circulating Tumor Cell Phenotype in Early Stage Breast Cancer Patients With Neoadjuvant Chemotherapy or Adjuvant Chemotherapy","Inclusion Criteria\n\n* The age is more than 18 years old;\n* Pathology confirmed malignant breast tumor;\n* No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection;\n* Life expectancy is greater than 6 month;\n* The main organ function is normal;\n* The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance.\n\nExclusion Criteria\n\n* Patients who had suffered from other malignant tumors;\n* With uncontrolled bacterial, viral or fungal infections;\n* With physical or mental disorders\n* Without or limited civil capacity;\n* Infected with human immunodeficiency virus (HIV)；\n* Circumstances in which the investigator considers it inappropriate to participate in this study.",{"count":566,"type":19},1000,"The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with\u002Fwithout adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.",[195,569,570],"Neoplastic Cells, Circulating","Chemotherapy Effect","2022-04-05",{"date":573,"type":32},"2022-04-13",{"date":575,"type":32},"2019-03-01",{"date":577,"type":19},"2029-03-01",{"name":38,"class":39},""]