Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06965231

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

Led by Fudan University · Updated on 2025-05-11

58

Participants Needed

4

Research Sites

221 weeks

Total Duration

On this page

Sponsors

F

Fudan University

Lead Sponsor

S

Shanghai Tong Ren Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • ECOG performance status 0-1
  • Confirmed cutaneous or acral malignant melanoma, excluding mucosal and uveal melanoma
  • Available BRAF, CKIT, and NRAS gene test results
  • No prior anti-tumor therapy (treatment-naive patients)
  • Clinical stage II melanoma by AJCC 8th edition (2017)
  • Laboratory values meeting specified hematology, biochemistry, and coagulation criteria
  • Left ventricular ejection fraction of 50% or higher by Doppler ultrasound
  • Female patients must agree to use contraception during study and for 6 months after, with negative pregnancy test before enrollment; must not be lactating
  • Male patients must agree to use contraception during study and for 6 months after
  • Voluntary participation with signed informed consent and good compliance
Not Eligible

You will not qualify if you...

  • History of allergic reactions to biological products
  • Prior or concurrent malignancies within 5 years except cured basal cell carcinoma or carcinoma in situ of cervix
  • Active autoimmune diseases or history of autoimmune disorders except certain controlled conditions
  • Need for immunosuppressive therapy with corticosteroids equivalent to prednisone over 10 mg/day within 2 weeks before first dose
  • History or evidence of bleeding disorders or recent significant bleeding events
  • Presence of unhealed wounds, fractures, active gastrointestinal ulcers, or tumors with active bleeding
  • Severe or uncontrolled medical conditions including poorly controlled hypertension, unstable heart conditions, severe infections, significant liver disease, HIV infection, poorly controlled diabetes, or significant proteinuria
  • Receipt of live vaccines within 4 weeks prior to treatment or expected need during study
  • Other conditions that may endanger patient safety or affect study participation as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

2

Cancer center, Shanghai 411 hospital, China RongTong Medical Healthcare Group Co.Ltd./411 Hospital, Shanghai University

Shanghai, Shanghai Municipality, China, 200081

Actively Recruiting

3

Department of Surgical Oncology, Fudan University Shanghai Cancer Center Minhang Branch Hospital

Shanghai, Shanghai Municipality, China, 200240

Actively Recruiting

4

Department of Oncology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200336

Actively Recruiting

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Research Team

C

Chunmeng Wang, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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