Condition: Melanoma of Skin · Acral Melanoma · Stage II Melanoma · Sponsor: Fudan University
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.
This description comes directly from the study's public registry record.
Chunmeng Wang, Dr. · +86 13671976170 · cmwang1975@163.com
Always discuss trial participation with your own doctor first.
| Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center | Shanghai, Shanghai Municipality, China | Recruiting |
| Cancer center, Shanghai 411 hospital, China RongTong Medical Healthcare Group Co.Ltd./411 Hospital, Shanghai University | Shanghai, Shanghai Municipality, China | Recruiting |
| Department of Surgical Oncology, Fudan University Shanghai Cancer Center Minhang Branch Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
| Department of Oncology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06965231