Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma

Primary Objective: To evaluate the effectiveness of Thymosin Alpha-1 combined with PD-1 monoclonal antibody in elderly patients with advanced melanoma . Secondary Objective: To evaluate the safety and tolerability of adenpeptide-α1 combined with PD-1 antibody in elderly patients with advanced melanoma . Study Design：Open-label, single-arm, non-controlled clinical trial. Primary Inclusion Criteria: 1. Age ≥60 years old; 2. Pathologically confirmed as inoperable or metastatic melanoma; 3. one or more lesions evaluable by RECIST1.1 standards. 4. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2; Main exclusion criteria: 1. Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months; 2. Received thymosin class drug treatment within 3 months before signing the informed consent. 3. Symptomatic, untreated central nervous system metastases. Treatment： Thymosin Alpha 1 1.6mg, sc，QD，d1-7;1.6mg, sc， three times per week, d8-21. Each 21 days is considered one cycle, for a total of 12 weeks. Anti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip，Q3W，4 cycles. Primary study endpoints: Objective Response Rate (ORR: CR+PR) Secondary study endpoints: Progression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS) Adverse Events (AEs)

Inclusion Criteria: 1. Aged 60 years or older; 2. Diagnosis of malignant melanoma confirmed by pathological histology or cytology examination. 3. According to the 8th edition of AJCC staging, patients with unresectable stage III or IV melanoma; 4. One or more lesions evaluable by RECIST1.1 standards. 5. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States has a score range of 0-2. 6. Total bilirubin ≤1.5× upper limit of normal (ULN); AST and AST \