RecruitingPhase 2NCT06965231

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

Efficacy and Safety of Perioperative Toripalimab Combined With Recombinant Human Endostatin as Postoperative Adjuvant Therapy for Clinical Stage II Malignant Melanoma: A Multicenter, Single-Arm, Phase II Clinical Study

Sponsor

Fudan University

Enrollment

58 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Acral Melanoma Melanoma of Skin Stage II Melanoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — toripalimab (an immunotherapy) and endostatin (an anti-tumor blood vessel drug) — given before and after surgery for people with stage II skin or acral (hand/foot) melanoma, to see if this combination reduces the risk of the cancer coming back. **You may be eligible if...** - You are 18 or older - You have confirmed melanoma of the skin or acral type (not mucosal or eye-related) - You have not yet received any anti-cancer treatment for this cancer - Your melanoma is stage II (based on the AJCC 8th edition staging system) - Your blood counts and organ function meet required thresholds - You have results for BRAF, CKIT, and NRAS gene tests **You may NOT be eligible if...** - You have previously received any anti-tumor therapy for this melanoma - You have active autoimmune disease requiring treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab 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).

Locations(4)

Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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

Shanghai, Shanghai Municipality, China

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

Shanghai, Shanghai Municipality, China

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

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06965231

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