[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pd-l1-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pd-l1-positive":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,70,91,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100623720","phase-2-sintilimab-combined-with-chemotherapy-for-adjuvant-treatment-of-mucosal-melanoma-after-surgery-100623720",false,"NCT07400302","Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery","A Randomized, Controlled, Multicenter Phase II Clinical Study Evaluating the Adjuvant Treatment of PD-L1-Positive, Resectable Mucosal Melanoma With Sintilimab Plus Chemotherapy Versus Chemotherapy Alone","Inclusion Criteria:\n\n1. Sign a written informed consent form (Informed Consent, ICF) and be able to comply with the visit schedule and related procedures outlined in the protocol.\n2. Histologically\u002Fcytologically confirmed mucosal melanoma, with primary and\u002For metastatic lesions completely resected, with negative surgical margins.\n3. Tissue specimen: PD-L1 positive (CPS ≥ 1).\n4. The first dose of the study drug must be administered only after the melanoma resection wound has fully healed, and the injection time must not exceed 13 weeks post-surgery (if the time limit is exceeded by no more than 7 days due to unforeseen circumstances, the decision to enroll may be discussed with the medical monitor).\n5. Confirmed R0 complete resection by physical examination and imaging within 4 weeks prior to randomization.\n6. For central nervous system (CNS) metastasis, post-surgical resection may receive adjuvant radiotherapy as needed. MRI of the brain must show no recurrence for at least 4 weeks after surgery or surgery combined with radiotherapy. Note: if immunosuppressants (e.g., prednisone) are required, they must be discontinued at least 14 days before the study drug administration.\n7. If lymph node dissection combined with local radiotherapy is required after melanoma resection, radiotherapy must be completed within 13 weeks of lymph node dissection and before the start of adjuvant treatment. Note: If delayed wound healing occurs due to radiotherapy, the subject will not meet the eligibility criteria.\n8. Age ≥ 18 years.\n9. Expected survival ≥ 12 weeks.\n10. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n11. Sufficient organ and bone marrow function, with laboratory values meeting the following criteria within 7 days before enrollment (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous corrective drugs should be given within 14 days prior to laboratory tests):\n\n(1) Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet Count (PLT) ≥ 90 × 10⁹\u002FL; Hemoglobin (HGB) ≥ 9.0 g\u002FdL (90 g\u002FL).\n\n(2) Liver Function: Total Bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN) (for patients suspected of or diagnosed with Gilbert's syndrome, TBIL ≤ 3 × ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN.\n\n(3) Renal Function: Serum Creatinine (Scr) ≤ 1.5 × ULN, or Creatinine Clearance Rate (Ccr) ≥ 50 ml\u002Fmin (calculated using the Cockcroft\u002FGault formula), and urinalysis showing urinary protein (UPRO) \\\u003C 2+ or 24-hour urinary protein \\\u003C 1g.(Cockcroft-Gault Formula) (4) Coagulation Function: International Normalized Ratio (INR) and Prothrombin Time (PT) ≤ 1.5 × ULN.\n\n12\\. Female subjects of childbearing potential, or male subjects whose partners are women of childbearing potential, must use effective contraception throughout the treatment period and for 6 months after treatment.\n\nExclusion Criteria:\n\n1. Previous exposure to any anti-PD-1 or anti-PD-L1\u002F2 antibody.\n2. Previous use of interferon.\n3. Hyperthyroidism or hypothyroidism. Note: Hypothyroid patients whose condition is stable after hormone replacement therapy may be included.\n4. Concurrent participation in another clinical trial.\n5. Receipt of any investigational drug within 4 weeks before the first dose of the study drug.\n6. Use of immunosuppressive drugs within 4 weeks prior to the first dose of the study drug, excluding nasal, inhaled, or other topical corticosteroids or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids).\n7. Receipt of live attenuated vaccines within 4 weeks before the first dose of the study drug or planned use during the study.\n8. Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) or any unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of the study drug.\n9. History of gastrointestinal perforation and\u002For fistulas within 6 months prior to the first dose of the study drug.\n10. Previous systemic anticancer treatment (e.g., chemotherapy, targeted therapy, or biologics). Chinese herbal medicine with anticancer indications or immunomodulatory drugs (e.g., thymosin, interleukins) are allowed after a 2-week washout period.\n11. Active, known, or suspected autoimmune diseases, or a history of autoimmune disease within the last 2 years (subjects with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy may be included).\n12. Known history of primary immunodeficiency.\n13. Known history of organ transplantation (except corneal transplant) or hematopoietic stem cell transplant.\n14. History of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or any pulmonary diseases with severe impairment of lung function.\n15. Known history of severe allergic reactions to other monoclonal antibodies or interferons, or to any ingredient in the study drug (e.g., sintilimab or interferon).\n16. Clinically uncontrolled third-space fluid accumulation, such as pleural effusion or ascites that cannot be controlled by drainage or other methods before enrollment.\n17. HIV infection (HIV antibody positive).\n18. Acute or chronic active hepatitis B (HBV DNA copy number ≥ 1 × 10³ copies\u002Fml or ≥ 200 IU\u002Fml) or acute or chronic active hepatitis C (HCV antibody positive); patients with HCV antibody positive but RNA negative are eligible for inclusion.\n19. Active pulmonary tuberculosis.\n20. Active or clinically uncontrolled severe infections.\n21. Symptomatic congestive heart failure (NYHA Class III-IV) or symptomatic or uncontrolled arrhythmia.\n22. Uncontrolled hypertension despite appropriate treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n23. Any arterial thromboembolic event (e.g., myocardial infarction, unstable angina, pulmonary embolism, cerebral embolism) within 6 months before enrollment.\n24. History of deep vein thrombosis or any other severe thromboembolic event within 3 months before enrollment (implanted venous infusion ports or catheter-related thrombosis or superficial vein thrombosis are not considered \"severe\" thromboembolic events).\n25. Uncontrolled metabolic disorders or other non-malignant organ\u002Fsystemic diseases or cancer sequelae that would increase medical risks and\u002For create uncertainties in survival prognosis, and the investigator judges that the patient is unsuitable for enrollment.\n26. Hepatic encephalopathy, hepatorenal syndrome, or decompensated cirrhosis (Child-Pugh Class B or C).\n27. History of gastrointestinal perforation and\u002For fistulae, bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), extensive bowel resection (e.g., partial colon or extensive small bowel resection resulting in chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within 6 months prior to enrollment.\n28. Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory test results that may:\n\n(1) Increase the risk related to participation in the study or study drug administration.\n\n(2) Interfere with the interpretation of study results and lead the investigator to determine that the patient is ineligible for participation.\n\n29\\. History of other primary malignancies, excluding:\n\n1. Malignancies that have been cured with no evidence of active disease for at least 5 years prior to enrollment, with a very low risk of recurrence.\n2. Non-melanoma skin cancer or malignant lentigo maligna with no evidence of disease recurrence after sufficient treatment.\n3. In situ carcinoma that has been treated sufficiently with no evidence of recurrence.\n\n30\\. Pregnant or breastfeeding female patients. 31. Other conditions that, according to the investigator's judgment, make the patient unsuitable for participation in the study.","ALL","18 Years",{"count":19,"type":20},220,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Melanoma has emerged as the fastest-growing malignancy in recent years, with incidence and mortality rates among both men and women in East Asian countries exceeding the Asian average. China ranks fifth among East Asian nations in melanoma incidence. Currently, immune checkpoint inhibitors are achieving significant breakthroughs in adjuvant melanoma therapy. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy alone in patients with PD-L1-positive, completely resectable mucosal melanoma, thereby providing additional clinical evidence for treatment decisions.",[26,27],"Mucosal Melanoma","PD-L1 Positive",[29,30,31,32],"Adjuvant Treatment","PD-L1-Positive","Resectable Mucosal Melanoma","immunotherapy","RECRUITING","2026-02-03",{"date":36,"type":37},"2026-02-10","ACTUAL",{"date":39,"type":20},"2026-02-01",{"date":41,"type":20},"2029-09-30",{"name":43,"class":44},"The First Hospital of Jilin University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100611768","phase-2-sac-tmt-combined-with-toripalimab-for-first-line-treatment-of-pd-l1-positive-amtnbc-100611768","NCT07244874","Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a\u002FmTNBC","A Single Arm, Phase II Study of Sacituzumab Tirumotecan（Sac-TMT） Combined With Toripalimab for First-line Treatment of PD-L1 Positive Unresectable Locally Advanced\u002FMetastatic Triple Negative Breast Cancer (a\u002FmTNBC)","Inclusion Criteria:\n\n1. Female patients with breast cancer aged \\>= 18 years.\n2. Based on the pathological report of the latest biopsy or other pathological specimens, the histology and\u002For cytology are confirmed as invasive breast cancer, and the following conditions are met: a) Pathological classification: ER \\\u003C= 10%, PR \\\u003C= 10%; HER2 negative (IHC 0, 1+, 2+and FISH negative); Note: Subjects with initial histopathological diagnosis of HR\\>10% or HER2+breast cancer and recent pathological findings of metastatic lesions meeting the above conditions are allowed to be included in the study. b) Tumor staging: locally advanced, recurrent, or metastatic tumors that cannot be surgically removed; Note: Patients who have received perioperative treatment in the past are required to have a disease-free survival period of \\>= 6 months;\n3. ECOG overall state is 0-1.\n4. Have not received systematic treatment for advanced diseases.\n5. There are tissue samples available for PD-L1 testing, and the test results show PD-L1 positive: CPS \\>= 1.\n6. The expected survival period is not less than 3 months.\n7. According to the RECIST v1.1 standard, there must be at least one measurable lesion present.\n8. Having sufficient organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to the first administration), defined as follows: a) Blood routine: neutrophil count (NEUT #) \\>= 1.5 × 10\\^9\u002FL; platelet count (PLT) \\>= 100 × 10\\^9\u002FL; hemoglobin \\>= 90g\u002FdL; b) Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) \\\u003C= 2.5 x upper limit of normal (ULN); Total bilirubin (TBIL) \\\u003C= 1.5 × ULN; For patients with liver metastases, ALT and AST should be \\\u003C= 5 × ULN, and TBIL should be \\\u003C= 2 × ULN; For patients with liver or bone metastases, ALP \\\u003C= 5 × ULN; c) Renal function: creatinine clearance rate (Ccr) \\>= 60ml\u002Fmin; d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) \\\u003C= 1.5 × ULN; e) Cardiac function: Echocardiography (ECHO) or multi circuit controlled acquisition (MUGA) scan shows left ventricular ejection fraction (LVEF) \\>= 50%;\n9. Patients must recover from all toxicity caused by previous treatment (to \\\u003C= grade 1, evaluated based on CTCAE 5.0, or meet the inclusion criteria of the protocol), except for hair loss and vitiligo.\n10. Patients with negative serum pregnancy test results and those with fertility potential must agree to use effective non hormonal contraceptive methods during treatment and for at least 6 months after the last use of the test drug.\n11. Voluntarily joining this study, signing informed consent, having good compliance, and willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients with central nervous system metastases.\n2. Received radiotherapy, endocrine therapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted therapy during the recurrence\u002Fmetastasis stage.\n3. Participated in clinical trials of other drugs within 4 weeks prior to enrollment.\n4. Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2, or anti-CTLA-4 antibodies, or any other antibodies or drugs that specifically target T cell co stimulatory or checkpoint pathways.\n5. Previously used treatment targeting TROP2 and\u002For topoisomerase I inhibitors.\n6. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cutaneous carcinoma, or squamous cell carcinoma of the skin.\n7. Known history of allergies to the drugs and their components in this protocol.\n8. Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.\n9. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n10. Vaccination with live vaccine within 30 days prior to the first study administration.\n11. History of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment, current ILD or non infectious pneumonia, or suspected ILD or non infectious pneumonia that cannot be excluded by imaging examination during screening; Clinical severe lung damage caused by concurrent lung diseases, including but not limited to any underlying lung disease (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc. within 3 months prior to administration) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (i.e. rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy.\n12. Patients with active autoimmune diseases that need systematic treatment in the past two years (hormone replacement therapy is not considered as systematic treatment, such as type I diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiological dose of glucocorticoid hormone replacement therapy).\n13. Active infections requiring systemic treatment within 2 weeks prior to the first administration.\n14. ccording to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to high blood pressure beyond the control of drugs, serious diabetes, active infection, etc.\n15. There is a recorded history of severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal diseases that hinder delayed corneal healing.\n16. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, and female patients of childbearing age who are unwilling to take effective contraceptive measures during the trial drug treatment period and the last 6 months of medication..\n17. The researchers believe that the patient is not suitable to participate in any other circumstances of this study.","FEMALE",{"count":55,"type":20},41,[23],"This study is aimed to evaluate the efficacy and safety of Sacituzumab Tirumotecan combined with Toripalimab for first-line treatment of PD-L1 positive unresectable Locally Advanced\u002Fmetastatic triple negative breast cancer (a\u002FmTNBC).",[59,27],"TNBC - Triple-Negative Breast Cancer","NOT_YET_RECRUITING","2025-11-17",{"date":63,"type":37},"2025-11-24",{"date":65,"type":20},"2025-12-01",{"date":67,"type":20},"2029-07-30",{"name":69,"class":44},"Tianjin Medical University Cancer Institute and Hospital",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":45},"100604780","phase-2-sacituzumab-tirumotecan-plus-tagitanlimab-in-previously-treated-locally-advanced-or-metastatic-triple-negative-breast-cancer-100604780","NCT07153965","Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer","An Open-label, Single-arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Tagitanlimab in Previously Treated PD-L1-positive Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)","Key inclusion criteria include but are not limited to:\n\n* Age ≥ 18 years at the time of signing informed consent.\n* Histologically and\u002For cytologically confirmed triple-negative breast cancer (TNBC) based on the most recent biopsy or other pathological specimens, including:\n\n  1. Definition of human epidermal growth factor receptor 2 (HER2) negative: immunohistochemistry (IHC) of 0 or 1+; if HER2 is 2+ by IHC, negative HER2 expression must be confirmed by fluorescencein situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC.\n  2. Tumor stage: locally advanced, recurrent, or metastatic TNBC; locally advanced cases must be confirmed by the investigator as unsuitable for curative surgical resection.\n* Patients with unresectable locally advanced or metastatic triple-negative breast cancer:\n\n  1. Those who have received chemotherapy combined with a PD-(L)1 inhibitor as first-line treatment for locally advanced or metastatic disease and experienced progression ≥ 3 months later.\n  2. Those who received chemotherapy combined with a PD-(L)1 inhibitor in the neoadjuvant and\u002For adjuvant setting and experienced recurrence or disease progression to unresectable locally advanced or metastatic disease ≥ 3 months later but within 12 months.\n  3. Those who received chemotherapy combined with a PD-(L)1 inhibitor in the neoadjuvant and\u002For adjuvant setting and experienced recurrence or disease progression to unresectable locally advanced or metastatic disease after ≥ 12 months, and have subsequently progressed on first-line treatment for locally advanced or metastatic disease.\n* Newly diagnosed brain metastases at screening must be stable for ≥ 4weeks after local treatment (e.g., radiotherapy) with imaging confirmation.\n* The most recent tumor tissue sample from the primary and\u002For metastatic lesion must show a PD-L1 combined positive score (CPS) ≥ 1.\n* Patients must have at least one measurable lesion per RECIST v1.1 criteria; those with only skin or bone lesions cannot be included.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to1.\n* Patients must have adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony stimulating factor therapy has been received within 2 weeks prior to the treatment)\n* Patients of childbearing potential (male or female) must use effective medical contraception from consent until 6 months after the end of the dosing period.\n\nKey exclusion criteria include but are not limited to:\n\n* Previously received any of the following treatments (including in the adjuvant or neoadjuvant setting):\n\n  1. Targeted TROP2 therapy.\n  2. Any drug treatment targeting topoisomerase I, including antibody drug conjugates (ADC) therapy.\n* Known to have meningeal metastasis, brainstem metastasis, spinalcord metastasis, and\u002For compression, active central nervous system(CNS) metastasis. Patients with previously treated brain metastases canparticipate if clinically stable for at least 4 weeks before dosing and do not require corticosteroids or anticonvulsants for at least 14 days. Patients with untreated asymptomatic brain metastases must require investigator approval.\n* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or corneal disease that prevents\u002Fdelays corneal healing.\n* Within 3 years before administration having other malignancies (except forthose cured by local treatment, such as basal cell carcinoma of the skin,squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.).\n* Has uncontrolled, significant cardiovascular disease or risk factors, uncontrollable systemic diseases.\n* Presence of steroid-requiring (non-infectious) interstitial lung disease (ILD)or a history of non-infectious pneumonia, currently having ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging at screening.\n* Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0) or the level specified in the inclusion and exclusion criteria.\n* Patients with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding.\n* Having an active autoimmune disease requiring systemic treatment inthe past two years.\n* Known active tuberculosis, hepatitis B or hepatitis C.\n* Human Immunodeficiency Virus (HIV) test positive or history of Acquired Immunodeficiency Syndrome (AIDS); known active syphilis infection.\n* Known allergy to the study drug or any of its components, known history of severe hypersensitivity to other biological products\n* Pregnant or breastfeeding women.",{"count":78,"type":20},47,[23],"This is an open-label, single-arm, multicenter phase II study to evaluate the safety and efficacy of sac-TMT plus Tagitanlimab in patients with PD-L1-positive locally advanced or metastatic TNBC.",[82,27],"Triple Negative Breast Cancer (TNBC)","2025-08-31",{"date":85,"type":37},"2025-09-04",{"date":87,"type":20},"2025-09-01",{"date":89,"type":20},"2027-09-01",{"name":69,"class":44},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100591630","phase-2-a-clinical-study-on-the-efficacy-and-safety-of-the-combination-of-limertinib-and-bevacizumab-versus-limertinib-as-first-line-treatment-for-nsclc-100591630","NCT06982924","A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC.","A Prospective, Controlled Phase II Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib Monotherapy as First - Line Treatment for Locally Advanced or Recurrent Metastatic Non - Squamous NSCLC With EGFR Mutations and High PD-L1 Expression.","LIBRA","Inclusion Criteria:\n\n1. Signed written informed consent prior to any study - related procedures.\n2. Age ≥ 18 years.\n3. Histologically or cytologically confirmed non - squamous non - small cell lung cancer (NSCLC).\n4. Patients with locally advanced (IIIB - IIIC), metastatic, or recurrent (Stage IV) disease, as staged according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer (AJCC) 9th edition TNM staging for lung cancer, who are not candidates for surgical or radiation therapy.\n5. Confirmed EGFR - sensitive mutations (Ex19del, L858R) in tumor histology or cytology or in hematology.\n6. PD - L1 expression with a Combined Positive Score (CPS) ≥ 25%.\n7. ECOG performance status score of 0 - 1.\n8. No prior treatment with anti - angiogenic inhibitors or EGFR - TKIs.\n9. At least one radiologically measurable lesion, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions within a previously irradiated field may be considered measurable if progression has been confirmed.\n10. Asymptomatic or symptomatic - stable brain metastases after local treatment are allowed, provided that the following conditions are met: - Measurable disease outside the central nervous system (CNS). - No CNS symptoms or worsening of symptoms within the past 2 weeks. - No need for glucocorticoid treatment, or glucocorticoid treatment discontinued within 7 days prior to the first dose, or stable and reduced glucocorticoid dose to ≤ 10 mg\u002Fday prednisone (or equivalent) within 7 days prior to the first dose.\n11. Expected survival time \\> 3 months.\n12. Adequate organ function, with the following laboratory values met by subjects: - Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL without the use of granulocyte - colony stimulating factor (G - CSF) within the past 14 days. - Platelets ≥ 100×10⁹\u002FL without blood transfusion within the past 14 days. - Hemoglobin \\> 9 g\u002FdL without blood transfusion or use of erythropoiesis - stimulating agents within the past 14 days. - Total bilirubin ≤ 1.5× the upper limit of normal (ULN). - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (for subjects with liver metastases, ALT or AST ≤ 5×ULN is allowed). - Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated using the Cockcroft - Gault formula) ≥ 60 ml\u002Fmin. - Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN. - Normal thyroid function, defined as thyroid - stimulating hormone (TSH) within the normal range. Subjects may also be included if their baseline TSH is outside the normal range but their total T3 (or free T3) and free T4 are within the normal range. - Cardiac enzyme profile within the normal range (isolated laboratory abnormalities deemed not clinically significant by the investigator are also allowed).\n13. For women of childbearing age, a negative urine or serum pregnancy test must be conducted within 3 days prior to the first dose of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is inconclusive, a blood pregnancy test is required. Non - childbearing - age women are defined as those who have been post - menopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy.\n14. All subjects (regardless of gender) with the potential for conception must use contraceptive measures with a failure rate of less than 1% throughout the entire treatment period and until 120 days (or 180 days) after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Pathologically diagnosed with small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and NSCLC.\n2. Patients who have received any EGFR - TKI treatment or anti - angiogenic therapy.\n3. Received the following treatments: - Systemic anti - tumor treatment such as chemotherapy, targeted therapy, or immunotherapy (including traditional Chinese medicine for anti - tumor purposes) within 3 weeks prior to treatment. - Any investigational drug treatment within 4 weeks prior to treatment. - High - dose immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg\u002Fday prednisone or equivalent doses) within 4 weeks prior to treatment. - Attenuated live vaccines within 4 weeks prior to treatment (or planned to receive attenuated live vaccines during the study period). - Major surgery (such as open - cavity, open - chest, or laparotomy) within 4 weeks prior to treatment, or unresolved surgical wounds, ulcers, or fractures.\n4. Clinically uncontrollable pleural effusion\u002Fperitoneal effusion (subjects who do not require drainage of effusion or whose effusion does not significantly increase after stopping drainage for 3 days are eligible for inclusion).\n5. Subjects who received chest radiotherapy with a dose greater than 30Gy within 6 months prior to treatment, or palliative radiotherapy with a dose of 30Gy or less within 7 days prior to treatment (palliative radiotherapy for bone lesions or intracranial lesions is allowed).\n6. Active autoimmune diseases that required systemic treatment (such as disease - modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose of study drug. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.\n7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n8. Known allergy to the active ingredients or excipients of the study drugs bevacizumab and lerotinib.\n9. Not fully recovered from the toxicity and\u002For complications caused by any intervention prior to the start of treatment (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or hair loss).\n10. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1\u002F2 antibodies).\n11. Untreated active hepatitis B (defined as positive for HBsAg and HBV - DNA copies greater than the upper limit of normal in the laboratory of the research center). Note: Subjects with hepatitis B who meet the following criteria are also eligible for inclusion: - HBV viral load \\\u003C 1000 copies\u002Fml (200 IU\u002Fml) prior to the first dose of study drug, and subjects should receive anti - HBV treatment throughout the study drug treatment period to prevent viral reactivation. - For subjects with positive anti - HBc, negative HBsAg, negative anti - HBs, and negative HBV viral load, preventive anti - HBV treatment is not required, but close monitoring for viral reactivation is necessary.\n12. Subjects with active HCV infection (positive for HCV antibodies and HCV - RNA levels above the lower limit of detection).\n13. Received live vaccines within 30 days prior to the first dose of study drug (Day 1 of Cycle 1). Note: It is allowed to receive injectable inactivated virus vaccines for seasonal influenza within 30 days prior to the first dose of study drug 2: however, intranasal attenuated live influenza vaccines are not allowed. 14. Pregnant or lactating women.\n\n15\\. Any severe or uncontrolled systemic disease, such as: - Significant and symptomatic abnormalities in rhythm, conduction, or morphology on resting electrocardiogram that are difficult to control, such as complete left bundle branch block, second - degree or higher cardiac conduction block, ventricular arrhythmias, or atrial fibrillation. - Unstable angina, congestive heart failure, chronic heart failure with a New York Heart Association (NYHA) classification of ≥ Grade 2. - Myocardial infarction within 6 months prior to enrollment. - Poorly controlled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg). - History of non - infectious pneumonia that required glucocorticoid treatment within 1 year prior to the first dose of study drug, or current clinically active interstitial lung disease. - Active pulmonary tuberculosis. - Active or uncontrolled infections that require systemic treatment. - Clinically active diverticulitis, intra - abdominal abscess, or gastrointestinal obstruction. - Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis. - Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL). - Urine routine test indicating proteinuria ≥ ++, and confirmed 24 - hour urine protein quantification \\> 1.0 g. - Subjects with mental disorders who are unable to cooperate with treatment.\n\n16\\. Any medical history or evidence of disease, treatment, or laboratory test abnormalities that may interfere with the study results or prevent the subject from fully participating in the study, or other situations deemed by the investigator as unsuitable for inclusion. The investigator considers there are other potential risks that make the subject unsuitable for participation in this study.",{"count":100,"type":20},136,[23],"A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.",[104,27],"EGFR Mutation Positive Advanced Non Small Cell Lung Cancer","2025-05-13",{"date":107,"type":37},"2025-05-21",{"date":109,"type":20},"2025-06-30",{"date":111,"type":20},"2028-12-30",{"name":113,"class":44},"Shanghai Chest Hospital",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100583798","phase-2-establishment-of-precision-targeted-therapy-strategies-for-advanced-gastric-cancer-based-on-novel-molecular-subtyping-100583798","NCT06881017","Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping","Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Histologically or pathologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction;\n3. Advanced or metastatic disease with no prior systemic therapy for advanced-stage disease (Patients who relapsed \\>6 months after completing neoadjuvant\u002Fadjuvant therapy are eligible, with prior neoadjuvant\u002Fadjuvant regimens not counted as prior lines of therapy);\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1);\n5. Archival or fresh tumor tissue sample available for biomarker testing (HER2, CLDN18.2, and PD-L1 expression);\n6. ECOG performance status: 0-1;\n7. Life expectancy ≥12 weeks;\n8. Adequate organ and bone marrow function meeting the following criteria:\n\n   1. Hemoglobin ≥90 g\u002FL (no blood transfusion within 14 days);\n   2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL;\n   3. Platelet count ≥90×10⁹\u002FL;\n   4. Total bilirubin ≤1.5×upper limit of normal (ULN);\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver metastases are present);\n   6. Serum creatinine ≤1.5×ULN;\n   7. Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; QTc interval \\\u003C450 ms for males and \\\u003C470 ms for females;\n9. Coagulation parameters:\n10. For patients not on anticoagulation therapy: INR ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n11. For patients receiving full-dose or parenteral anticoagulation: Stable anticoagulant dose for ≥2 weeks prior to enrollment, with coagulation tests within the therapeutic range;\n12. Contraception requirements:\n13. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and agree to use effective contraception during the study and for 3 months after the last dose;\n14. Men must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose;\n15. Recovery from prior therapy-related toxicities to ≤Grade 1 (surgical wounds must be fully healed if applicable);\n16. Voluntary participation with signed informed consent form and anticipated adherence to protocol requirements.\n\nExclusion Criteria:\n\n1. History of gastrointestinal perforation and\u002For fistula within 6 months prior to treatment, or active gastrointestinal bleeding within 3 months;\n2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage;\n3. Known history of hypersensitivity to any component of the investigational drug(s) or excipients;\n4. Prior treatments meeting any of the following:\n\n   1. Received any investigational drug within 4 weeks prior to the first dose of the study drug or within 5 half-lives of the last investigational agent (whichever is shorter);\n   2. Concurrent enrollment in another interventional clinical study (observational or follow-up studies are permitted);\n   3. Received antitumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologics, or tumor embolization) within 2 weeks prior to the first dose of the study drug;\n5. History of leptomeningeal metastasis or current active brain metastases;\n6. Severe infection (CTCAE v5.0 Grade \\>2) within 4 weeks prior to the first dose of the study drug (e.g., pneumonia requiring hospitalization, bacteremia, or septic complications); active pulmonary inflammation on baseline chest imaging, or signs\u002Fsymptoms of infection requiring oral\u002FIV antibiotics within 2 weeks prior to the first dose (prophylactic antibiotics excluded);\n7. History of interstitial lung disease (except radiation pneumonitis without steroid treatment or non-infectious pneumonitis);\n8. Active tuberculosis (TB) infection confirmed by medical history or CT scan, history of active TB within 1 year prior to enrollment, or untreated active TB diagnosed \\>1 year prior to enrollment;\n9. Diagnosis of another malignancy within 5 years prior to the first dose of the study drug, except malignancies with low metastatic\u002Flethal risk (5-year survival rate \\>90%), such as adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;\n10. Pregnant or lactating women;\n11. Other conditions deemed by the investigator to jeopardize subject safety or trial integrity, including severe comorbidities (e.g., psychiatric disorders), clinically significant laboratory abnormalities, or social\u002Ffamily factors that may compromise protocol adherence or data collection.",{"count":122,"type":20},140,[23],"This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.",[126,127,128,27],"Gastric Cancer","HER2 + Gastric Cancer","CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction",[130,131,132,133],"gastric cancer","HER2","CLDN18.2","PD-L1","2025-03-17",{"date":136,"type":37},"2025-03-18",{"date":138,"type":20},"2025-05-01",{"date":140,"type":20},"2029-11-01",{"name":142,"class":44},"China Medical University, China"]