RecruitingPhase 2NCT07400302

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


Sponsor

The First Hospital of Jilin University

Enrollment

220 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding sintilimab — an immunotherapy drug that helps the immune system fight cancer — to chemotherapy as an adjuvant (post-surgery) treatment can prevent mucosal melanoma from coming back. Mucosal melanoma is a rare and aggressive cancer that arises in mucous membranes (such as the mouth, sinuses, or digestive tract), and it has fewer treatment options than skin melanoma. **You may be eligible if...** - You are 18 or older - You have confirmed mucosal melanoma that was completely surgically removed (negative margins) - Your tumor is PD-L1 positive (a marker showing the immune system may respond to immunotherapy) - You have not received any prior immunotherapy, interferon, or chemotherapy for this cancer - Your cancer has not come back based on recent imaging **You may NOT be eligible if...** - You have previously taken any anti-PD-1 or anti-PD-L1 immunotherapy drug - You have active autoimmune disease requiring treatment - You have active hepatitis B, C, HIV, or tuberculosis - You have serious heart conditions or uncontrolled high blood pressure - 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

DRUGSintilimab

Sintilimab 200 mg IV Q3W for 6 cycles. Followed by maintenance therapy with sintilimab 200 mg IV Q3W for 1 year.

DRUGDacarbazine or Temozolomide

Dacarbazine 250 mg/m² or Temozolomide 200 mg/m² QD D1-5 Q3W for 6 cycles.

DRUGCisplatin

Cisplatin 75 mg/m² IV D1-3 Q3W, administered in combination for 6 cycles.


Locations(1)

The first hospital of Jilin University

Changchun, Jilin, China

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NCT07400302


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