drugset / Trial / NCT07400302

Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery

NCT07400302

Phase 2 Recruiting 220 enrolled The First Hospital of Jilin University
RandomizedParallel-groupSingle-blindTreatment

Summary

Melanoma has emerged as the fastest-growing malignancy in recent years, with incidence and mortality rates among both men and women in East Asian countries exceeding the Asian average. China ranks fifth among East Asian nations in melanoma incidence. Currently, immune checkpoint inhibitors are achieving significant breakthroughs in adjuvant melanoma therapy. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy alone in patients with PD-L1-positive, completely resectable mucosal melanoma, thereby providing additional clinical evidence for treatment decisions.

Timeline

Start
2026-02-01
Primary completion
2029-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Dacarbazine Small molecule 250 mg/m2
Background Temozolomide Small molecule 200 mg/m2

Indications