melanoma
Conditions
Interventions
Experimental group:QL1706 (5 mg/kg, IV, Q3W) administered in 3-week treatment cycles. Two cycles are given preoperatively, followed by curative surgery scheduled within 6 weeks after completion of neo
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. ECOG PS score 0–1; 3. Patients with histologically or cytologically confirmed acral or mucosal melanoma, radiographically confirmed stage III or IV disease expected to be completely resectable (M1a); or patients with locally recurrent disease after initial treatment or adjuvant therapy for more than 12 weeks following curative surgery. 4. Subjects must have at least one unresectable non-bone lesion measurable radiologically (based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and consent to PD-L1 and other biomarker testing; 5. Life expectancy of at least 3 months; 6. Adequate function of other major organs (liver, kidneys, hematologic system, etc.): - Hemoglobin >= 9.0 g/dL (may be maintained or exceeded via transfusion); - Red blood cell count >= 2.0 × 10?/L - White blood cell count >= 2.0 × 10?/L - Absolute neutrophil count (ANC) >= 1.5 × 10?/L; - Platelet count >= 100×10?/L; - Total bilirubin within normal limits; - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase = 50 mL/min; - For patients not receiving anticoagulant therapy: Prothrombin time International Normalized Ratio (INR) <= 1.5, Activated Partial Thromboplastin Time (APTT) <= 1.5 times ULN. Patients receiving full-dose or parenteral anticoagulants may be enrolled provided the anticoagulant dose has been stable for at least 2 weeks prior to study entry and coagulation test results fall within locally therapeutic ranges. 7. No immunosuppressive medication use within 6 months prior to study entry. 8. Adequate pulmonary function to tolerate surgical intervention. 9. Women of childbearing potential (WOCBP) must use effective contraception. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of hCG) within 7 days prior to study entry and must agree to continue contraception for 120 days after the last study drug dose; 10. Males who engage in sexual intercourse with WOCBP during treatment and for 120 days after the last dose of study drug must use any contraceptive method with an annual failure rate below 1%; 11. Patients are able to understand and comply with protocol requirements and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received any systemic anticancer therapy for melanoma within the past 12 weeks, including radical resection, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, or experimental treatment; 2. Presence of systemic metastases; 3. History of other malignancies, except for: adequately treated localized basal cell carcinoma; cervical carcinoma in situ; adequately treated, papillary, non-invasive bladder cancer; other adequately treated Stage I-II cancers currently in complete remission; or any other cancer in complete remission for at least 2 years; 4. Currently participating in an interventional clinical trial, or having received another investigational drug or device within 4 weeks prior to the first dose; 5. Major surgery (craniotomy, thoracotomy, or laparotomy) within 8 weeks prior to first dose, or presence of unhealed wounds, ulcers, or fractures; 6. Clinically uncontrolled pleural effusion/ascites (patients requiring no drainage or with no significant increase in effusion volume within 3 days after drainage cessation may be eligible); 7. Symptomatic central nervous system metastases; 8. Concurrent unstable systemic diseases, such as uncontrolled hypertension or severe arrhythmias; 9. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying antirheumatic drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first study dose; 10. Receiving systemic glucocorticoid therapy (excluding intranasal, inhaled, or other topical glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks prior to the first study dose; 11. Receiving a live attenuated vaccine within 4 weeks prior to the first study dose; 12. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 13. Allergy to the study drug; 14. History or current presence of interstitial lung disease; 15. Known history of human immunodeficiency virus (HIV) infection; 16. Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy number > ULN) and active HCV infection (HCV antibody positive with HCV-RNA level > ULN); 17. Pregnant or lactating women; 18. Individuals with neurological or psychiatric disorders rendering them unable to cooperate; 19. History or evidence of disease, treatment, or laboratory abnormalities that may interfere with study results or prevent full participation, or other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Response Rate;Objective response rate;Radical surgical resection rate;Event-free survival;Recurrence-free survival time;Adverse events; | — |
Countries
China
Contacts
Public ContactYu Chen
Fujian Cancer Hospital
Outcome results
None listed