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)

Trial Details

NCT ID
NCT07644897
Phase
PHASE2
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

  • Aged 60 years or older;
  • Diagnosis of malignant melanoma confirmed by pathological histology or cytology examination.
  • According to the 8th edition of AJCC staging, patients with unresectable stage III or IV melanoma;
  • One or more lesions evaluable by RECIST1.1 standards.

For full eligibility, visit ClinicalTrials.gov.

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