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

NCT07400302 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-02-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400302 on ClinicalTrials.gov