[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-ii-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-ii-melanoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100590270","phase-2-perioperative-toripalimab-and-endostatin-for-stage-ii-melanoma-a-phase-ii-trial-100590270",false,"NCT06965231","Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial","Efficacy and Safety of Perioperative Toripalimab Combined With Recombinant Human Endostatin as Postoperative Adjuvant Therapy for Clinical Stage II Malignant Melanoma: A Multicenter, Single-Arm, Phase II Clinical Study","FUMS-EDJS2024","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender;\n2. ECOG performance status: 0-1;\n3. Patients with histologically or cytologically confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma;\n4. Patients with BRAF, CKIT, and NRAS gene test results;\n5. Treatment-naïve patients who have not received prior anti-tumor therapy;\n6. Clinical stage II (AJCC 8th edition, 2017);\n7. Laboratory tests must meet the following criteria:\n\n   1. Hematology: Hemoglobin (Hb) ≥90 g\u002FL (no transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; platelet count (PLT) ≥100×10\\^9\u002FL;\n   2. Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance \\>50 μmol\u002FL;\n   3. Coagulation: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤1.5×ULN;\n   4. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%;\n8. Female patients must agree to use contraception (e.g., intrauterine device \\[IUD\\], oral contraceptives, or condoms) during the study and for 6 months after study completion. A negative serum or urine pregnancy test within 7 days before enrollment is required, and patients must be non-lactating. Male patients must agree to use contraception during the study and for 6 months after study completion;\n9. Patients must voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.\n\nExclusion Criteria:\n\n1. History of allergic reactions to biological products;\n2. Patients with prior or concurrent malignancies within 5 years (except cured basal cell carcinoma of skin or carcinoma in situ of cervix);\n3. Any active autoimmune disease or history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring bronchodilators for medical intervention). Exceptions include: vitiligo, psoriasis, alopecia not requiring systemic therapy, well-controlled type I diabetes, or hypothyroidism with normal thyroid function on replacement therapy;\n4. Requirement for immunosuppressive therapy using systemic or absorbable topical corticosteroids (equivalent to prednisone \\>10mg\u002Fday) within 2 weeks prior to first dose;\n5. Any history or evidence of bleeding diathesis regardless of severity; grade ≥3 bleeding events per CTCAE v5.0 within 4 weeks prior to first dose; or presence of unhealed wounds, fractures, active gastrointestinal ulcers, ulcerative colitis, tumors with active bleeding, or other conditions deemed by investigators to potentially cause gastrointestinal hemorrhage or perforation;\n6. Patients with severe and\u002For uncontrolled comorbidities including:\n\n   1. Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥90 mmHg);\n   2. Unstable angina, myocardial infarction, ≥grade 2 congestive heart failure, or arrhythmias requiring treatment (including QTc ≥480ms) within 6 months prior to first dose;\n   3. Active or uncontrolled severe infections (≥grade 2 per CTCAE);\n   4. Clinically significant liver disease including viral hepatitis (active HBV infection with HBV DNA \\>1×10³ copies\u002FmL or \\>500 IU\u002FmL; HCV infection with HCV RNA \\>1×10³ copies\u002FmL or \\>100 IU\u002FmL), decompensated liver disease, or chronic hepatitis requiring antiviral therapy;\n   5. HIV-positive status;\n   6. Poorly controlled diabetes (fasting glucose ≥grade 2 per CTCAE);\n   7. Urinalysis showing proteinuria ≥++ with 24-hour urinary protein \\>1.0 g;\n7. Administration of live vaccines within 4 weeks prior to treatment or anticipated need during study;\n8. Other conditions deemed by investigators to potentially lead to premature study termination, including: severe comorbidities (including psychiatric disorders) requiring concomitant therapy, significant laboratory abnormalities, or social\u002Ffamily factors that may compromise patient safety or data\u002Fsample collection.","ALL","18 Years",{"count":20,"type":21},58,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II clinical trial to evaluate the efficacy and safety of perioperative toripalimab (anti-PD-1) combined with recombinant human endostatin (Endostar) as postoperative adjuvant therapy in patients with clinical stage II cutaneous or acral malignant melanoma. The study aims to answer:\n\n1. Does this combination improve the 2-year recurrence-free survival (2y-RFS) compared to historical data?\n2. Is the treatment safe and tolerable for patients?\n\nParticipants will:\n\n1. Receive 2 cycles of toripalimab before surgery (neoadjuvant therapy).\n2. Undergo surgical removal of the tumor.\n3. Post surgery, receive toripalimab every 2 weeks + Endostar (72-hour continuous infusion every 4 weeks) for up to 6 cycles (Endostar) or 11 cycles (toripalimab).\n4. Be monitored for tumor recurrence, side effects, and survival for up to 2 years after treatment.\n\nThis is a single-arm, multicenter study involving 58 patients across several hospitals in China. Results will help determine if this combination could become a new standard adjuvant therapy for stage II melanoma.",[27,28,29],"Melanoma of Skin","Acral Melanoma","Stage II Melanoma",[31,32,33,34,35,36,37,38,39],"Melanoma of skin","Acral melanoma","Stage II melanoma","Toripalimab","Recombinant human endostatin (Endostar)","Perioperative immunotherapy","PD-1 inhibitor","Anti-angiogenic therapy","Phase II study","RECRUITING","2025-05-07",{"date":43,"type":44},"2025-05-11","ACTUAL",{"date":46,"type":44},"2025-01-01",{"date":48,"type":21},"2029-03-30",{"name":50,"class":51},"Fudan University","OTHER",4]