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

NCT06965231 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-05-11

No results posted yet for this study

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.

Conditions

  • Melanoma of Skin
  • Acral Melanoma
  • Stage II Melanoma

Interventions

DRUG

Toripalimab combined with Endostar

1. Neoadjuvant Phase: 2 doses of toripalimab (240 mg IV, Q2W) before surgery. 2. Surgery: Tumor resection within 2 weeks after the last neoadjuvant dose. 3. Adjuvant Phase: 1) Toripalimab: 240 mg IV every 2 weeks (up to 11 cycles); 2) Endostar: 210 mg (72-hour continuous IV infusion) every 4 weeks (up to 6 cycles).

Sponsors & Collaborators

  • Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator UNKNOWN

  • Shanghai 411 hospital

    collaborator UNKNOWN

  • Fudan University

    lead OTHER

Principal Investigators

  • Chunmeng Wang, Dr. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-12-30
Completion
2029-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965231 on ClinicalTrials.gov