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)