[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"molecular-targeted-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:molecular-targeted-therapy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100581294","phase-2-benmelstobart-anlotinib-chemo-for-neoadjuvant-oral-cancer-100581294",false,"NCT06848439","Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer","A Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients With Locally Advanced Oral Cancer","Inclusion Criteria:\n\n* Potential subjects must meet all of the following criteria to be eligible for inclusion in this study:\n* Age 18-75 years;\n* ECOG PS score of 0-1;\n* Pathologically confirmed untreated oral squamous cell carcinoma patients, classified as stage III-IVb according to the AJCC (8th edition) staging system;\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 be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized;\n\nSigned informed consent form by the participant, with good compliance.\n\nExclusion Criteria:\n\nPotential subjects must be excluded from the study if they meet any of the following criteria:\n\n* Prior treatment with PD-1\u002FPD-L1\u002FCTLA-4 antibodies.\n* Tumor invasion of major blood vessels.\n* Requirement for systemic corticosteroid therapy (\\>10 mg prednisone equivalent per day) or other immunosuppressive treatment within 14 days before administration or during treatment. Inhaled or topical steroids and adrenal corticosteroid replacement therapy at ≤10 mg\u002Fday prednisone equivalent are allowed in the absence of active autoimmune disease.\n* History of any active immune-related or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Active or uncontrolled severe infection (≥ Grade 2 NCI CTCAE v5.0 infection) within 4 weeks prior to enrollment.\n* Coagulation disorders (INR \\>1.5, prothrombin time (PT) \\> ULN + 4 sec, or APTT \\>1.5 × ULN), a tendency for bleeding, or undergoing thrombolytic or anticoagulant therapy. Note: The use of low-dose heparin (adult daily dose of 6,000-12,000 U) or low-dose aspirin (daily dose ≤100 mg) for prophylactic purposes is allowed if INR ≤1.5.\n* Imaging evidence of tumor invasion of major blood vessels or tumors highly likely to invade major blood vessels and cause fatal hemorrhage during the study, as assessed by the investigator.\n* Any signs or history of a bleeding tendency, regardless of severity. Patients with bleeding or hemorrhagic events (≥CTCAE Grade 2) within 4 weeks prior to randomization, or those with unhealed wounds, ulcers, or fractures.\n* Major organ dysfunction:\n\nHematological abnormalities (without correction via blood transfusion, blood products, G-CSF, or other hematopoietic stimulants within 14 days):\n\n1. Hemoglobin (HB) \\\u003C90 g\u002FL.\n2. Absolute neutrophil count (ANC) \\\u003C1.5 × 10⁹\u002FL.\n3. Platelets (PLT) \\\u003C100 × 10⁹\u002FL.\n\nBiochemical abnormalities:\n\n1. Total bilirubin (TBIL) \\>1.5 × ULN.\n2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\>2.5 × ULN.\n3. Serum creatinine (Cr) \\>1.5 × ULN or creatinine clearance rate (CCr) \\\u003C60 mL\u002Fmin. Doppler ultrasound abnormalities: Left ventricular ejection fraction (LVEF) \\\u003C60%.\n\nThyroid function abnormalities: TSH \\> ULN with abnormal T3 and T4 levels. Renal dysfunction: Urine protein ≥++ on urinalysis or confirmed 24-hour urine protein level ≥1.0 g.\n\n* History of myocardial ischemia (≥Grade I), myocardial infarction, arrhythmia (QTc ≥480 ms), or ≥Grade 2 congestive heart failure (NYHA classification) within 6 months before enrollment.\n* Diagnosis of another malignancy within 3 years prior to enrollment.\n* Any severe and\u002For uncontrolled disease, including:\n\n  1. Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg), history of myocardial ischemia (≥Grade I), myocardial infarction, arrhythmia (QT interval ≥430 ms), or heart failure (NYHA Grade I).\n  2. Active or uncontrolled severe infection.\n  3. Liver cirrhosis, decompensated liver disease, or active hepatitis (HBV or HCV).\n  4. Poorly controlled diabetes (fasting blood glucose (FBG) \\>10 mmol\u002FL).\n  5. Urine protein ≥2+ and confirmed 24-hour urine protein \\>1.0 g.\n* Presence of long-term unhealed wounds or fractures.\n* Lung hemorrhage (\\>Grade 1 NCI CTC AE v4.0) within 4 weeks before enrollment or hemorrhage in other areas (\\>Grade 2 NCI CTC AE v4.0) within 4 weeks before enrollment. Patients with a tendency to bleed (e.g., active gastrointestinal ulcers) or those receiving thrombolytic or anticoagulant therapy (e.g., warfarin, heparin, or similar agents).\n* History of gastrointestinal perforation and\u002For fistula within 6 months before treatment initiation; or history of arterial\u002Fvenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism.\n* Imaging evidence of tumor invasion of major blood vessels or tumors highly likely to invade major blood vessels and cause fatal hemorrhage, as assessed by the investigator.\n* Clinically significant ascites, including any detectable ascites on physical examination or ascites requiring treatment. Patients with only mild asymptomatic ascites detected by imaging may be enrolled.\n* Uncontrolled metabolic disorders or other non-malignant systemic diseases or conditions secondary to cancer that may pose a high medical risk and\u002For create uncertainty in survival assessment.\n* Participation in other anti-tumor clinical trials within 4 weeks prior to enrollment.\n* History of substance abuse that cannot be discontinued or the presence of psychiatric disorders.\n* Any other conditions determined by the investigator that may pose serious risks to patient safety, confound study results, or affect the patient's ability to complete the study.","ALL","18 Years","75 Years",{"count":20,"type":21},26,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer\n\nThis is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:\n\nGroup A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy\u002F5 weeks.\n\nGroup B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy\u002F5 weeks.\n\nGroup C (Partial Pathological Response\u002FNo Pathological Response):\n\nLow-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy\u002F6 weeks.\n\nHigh-risk patients (extracapsular nodal extension and\u002For positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy\u002F6-6.6 weeks + Cisplatin: 60mg\u002Fm² every 3 weeks, 2-3 cycles.\n\nAdditionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).",[27,28,29,30],"Mouth Neoplasms","Neoadjuvant Therapy","Immunotherapy","Molecular Targeted Therapy",[27,32,29,30],"Neoadjuvant therapy","NOT_YET_RECRUITING","2025-05-27",{"date":36,"type":37},"2025-05-31","ACTUAL",{"date":39,"type":21},"2025-06-15",{"date":41,"type":21},"2028-12-31",{"name":43,"class":44},"Jiangsu Cancer Institute & Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100556280","phase-2-vorolanib-plus-sintilimab-for-advanced-renal-cell-carcinoma-after-failure-of-prior-immune-checkpoint-inhibitors-based-combination-therapy-100556280","NCT06523049","Vorolanib Plus Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy","A Prospective, Multicenter, Phase II Clinical Trial of Vorolanib in Combination With Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years, any gender.\n2. Histologically confirmed diagnosis of renal cell carcinoma.\n3. Diagnosis of metastatic renal cell carcinoma or TNM stage IV (according to the 2017 TNM staging system). Evidence of distant metastasis by imaging or pathology.\n4. Prior immune checkpoint inhibitors based combination therapy, dual immune combination, or immune monotherapy with disease progression, or who have received second\u002Fthird line targeted monotherapy, immune monotherapy, or a change in immune-based combination therapy after failure of one of the above therapies for no more than 1 month and have completed the washout period. ECOG performance status ≤2.\n5. Life expectancy of at least 3 months.\n6. Signed informed consent and ability to comply with the protocol-specified visits and procedures.\n7. Agreement to provide tumor tissue and blood specimens required for the study.\n8. Adequate organ and bone marrow function as follows: absolute neutrophil count (ANC) ≥1×10\\^9\u002FL, platelets (PLT) ≥50×10\\^9\u002FL, hemoglobin (HGB) ≥80g\u002FL; liver function: serum total bilirubin (TBIL) ≤3 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤5 times ULN, serum albumin (ALB) ≥20 g\u002FL; renal function: serum creatinine (Cr) ≤3×ULN.\n\nExclusion Criteria:\n\n1. Pathologically diagnosed with non-renal cell carcinoma, collecting duct carcinoma.\n2. First-line treatment with targeted monotherapy, or progression after first-line immune checkpoint inhibitors based combination therapy, followed by more than 1 month of treatment with targeted therapies, anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies specifically targeting T cell co-stimulation or checkpoint pathways and\u002For incomplete washout period.\n3. Active brain metastases.\n4. Personal history of other malignant tumors within 3 years with a different primary site or histology than that being evaluated in this study, excluding patients with well-controlled basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia.\n5. Major surgery or severe trauma within 4 weeks prior to enrollment.\n6. Subjects with conditions requiring systemic corticosteroids (\\>10mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days prior to initial study drug administration. Subjects with inactive autoimmune disease are allowed to receive local, ophthalmic, intra-articular, intranasal, inhaled corticosteroids, or adrenal replacement steroids (\\>10mg\u002Fday prednisone dose or equivalent).\n7. Known or suspected active autoimmune disease (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. Subjects with type 1 diabetes, thyroid dysfunction requiring only hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment, or conditions expected not to recur in the absence of external triggering factors are allowed to participate in this study. Known allogeneic organ transplant (excluding corneal transplant) or allogeneic hematopoietic stem cell transplant.\n8. Allergy to any component of monoclonal antibodies.\n9. Uncontrolled other severe diseases, including but not limited to:\n\n   1. Severe infection in the active or poorly controlled clinical phase;\n   2. HIV infection (HIV antibody positive);\n   3. Acute or chronic active hepatitis B (HBsAg positive and HBV DNA \\>1\\*103\u002Fml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA \\>15IU\u002Fml);\n   4. Active pulmonary tuberculosis, etc.\n10. NYHA class III-IV congestive heart failure, persistent symptomatic arrhythmia, uncontrolled atrial fibrillation; multiple echocardiographic assessments of left ventricular ejection fraction (LVEF) lower than the lower limit of normal.\n11. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg);\n12. Any arterial thrombosis, embolism, or ischemia in the past 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.;\n13. Diseases requiring warfarin (coumarin) anticoagulant therapy;\n14. Uncontrolled hypercalcemia (calcium ion \\>1.5 mmol\u002FL or calcium \\>12 mg\u002FdL or corrected serum calcium \\>ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy;\n15. Uncontrolled adrenal insufficiency;\n16. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months;\n17. Severe, non-healing wounds or ulcers;\n18. Gastrointestinal diseases with impaired gastrointestinal function (such as malabsorption, ulcerative disease, uncontrollable nausea, vomiting, diarrhea, or small bowel resection);\n19. Other acute or chronic diseases, mental illnesses, or laboratory abnormalities that may lead to the following outcomes: increased risk associated with study participation or drug administration, or interference with interpretation of study results, and deemed ineligible for study participation at the discretion of the investigator;\n20. Pregnant or lactating women.",{"count":54,"type":21},67,[24],"This Phase II trial assesses Vorolanib and Sintilimab for advanced renal cell carcinoma after previous therapy failure. Participants receive the treatment until disease progression, intolerable side effects, death, or withdrawal. The primary endpoint is progression-free survival (PFS).",[58,29,30],"Renal Cell Carcinoma",[60,61],"Vorolanib","Sintilimab","2024-07-25",{"date":64,"type":37},"2024-07-26",{"date":66,"type":21},"2024-08",{"date":68,"type":21},"2026-09",{"name":70,"class":44},"Hao Zeng"]