Perioperative Toripalimab and Endostatin for Stage II Melanoma: A Phase II Trial
Status:
RECRUITING
Trial end date:
2029-03-30
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Fudan University
Collaborators:
Shanghai 411 hospital Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine