NCT07400302

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

A Randomized, Controlled, Multicenter Phase II Clinical Study Evaluating the Adjuvant Treatment of PD-L1-Positive, Resectable Mucosal Melanoma With Sintilimab Plus Chemotherapy Versus Chemotherapy Alone

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucosal Melanoma
• PD-L1 Positive

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200 mg IV Q3W for 6 cycles. Followed by maintenance therapy with sintilimab 200 mg IV Q3W for 1 year.
DRUG	Dacarbazine or Temozolomide	Dacarbazine 250 mg/m² or Temozolomide 200 mg/m² QD D1-5 Q3W for 6 cycles.
DRUG	Cisplatin	Cisplatin 75 mg/m² IV D1-3 Q3W, administered in combination for 6 cycles.

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-09-30
• Completion: 2029-09-30
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: China