Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial

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: 1. Does this combination improve the 2-year recurrence-free survival (2y-RFS) compared to historical data? 2. Is the treatment safe and tolerable for patients? Participants will: 1. Receive 2 cycles of toripalimab before surgery (neoadjuvant therapy). 2. Undergo surgical removal of the tumor. 3. P

Trial Details

NCT ID
NCT06965231
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Toripalimab combined with Endostar
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Age ≥ 18 years, regardless of gender;
  • ECOG performance status: 0-1;
  • Patients with histologically or cytologically confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma;
  • Patients with BRAF, CKIT, and NRAS gene test results;

For full eligibility, visit ClinicalTrials.gov.

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