Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial (FUMS-EDJS2024)

  • STATUS
    Recruiting
  • End date
    Mar 30, 2029
  • participants needed
    58
  • sponsor
    Fudan University
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Updated on 14 June 2025

Summary

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. Post surgery, receive toripalimab every 2 weeks + Endostar (72-hour continuous infusion every 4 weeks) for up to 6 cycles (Endostar) or 11 cycles (toripalimab).
  4. Be monitored for tumor recurrence, side effects, and survival for up to 2 years after treatment.

This is a single-arm, multicenter study involving 58 patients across several hospitals in China. Results will help determine if this combination could become a new standard adjuvant therapy for stage II melanoma.

Details
Condition Melanoma of Skin, Acral Melanoma, Stage II Melanoma
Age 18years or above
Clinical Study IdentifierNCT06965231
SponsorFudan University
Last Modified on14 June 2025

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