Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07400302

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

Led by The First Hospital of Jilin University · Updated on 2026-02-10

220

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent and follow study procedures
  • Mucosal melanoma confirmed by tissue tests with complete surgical removal and negative margins
  • PD-L1 positive tissue sample with CPS ≥ 1
  • First dose given only after surgical wound has fully healed, within 13 weeks after surgery
  • Confirmed complete tumor removal by physical exam and imaging within 4 weeks before study start
  • For brain metastases, no recurrence on MRI at least 4 weeks after surgery or surgery plus radiotherapy
  • If lymph node removal and radiotherapy done, radiotherapy completed within 13 weeks before treatment
  • Age 18 years or older
  • Expected survival of at least 12 weeks
  • ECOG performance status score of 0 or 1
  • Adequate organ and bone marrow function based on lab tests within 7 days before enrollment
  • Effective contraception use during treatment and for 6 months after (for women of childbearing potential and male partners)
Not Eligible

You will not qualify if you...

  • Previous treatment with anti-PD-1 or anti-PD-L1/2 antibodies
  • Previous interferon treatment
  • Unstable thyroid conditions (hyperthyroidism or hypothyroidism not controlled by hormone therapy)
  • Currently enrolled in another clinical trial
  • Use of investigational drugs within 4 weeks before study start
  • Use of immunosuppressive drugs within 4 weeks before study start, except certain corticosteroids
  • Live attenuated vaccines within 4 weeks before or planned during study
  • Major surgery or unhealed wounds within 4 weeks before study start
  • History of gastrointestinal perforation or fistulas within 6 months before study start
  • Prior systemic anticancer treatments (except some Chinese herbal or immunomodulatory drugs)
  • Active or recent autoimmune diseases except certain controlled conditions
  • Known primary immunodeficiency or organ transplant history (except corneal transplant)
  • Serious lung diseases or impaired lung function
  • Severe allergic reactions to monoclonal antibodies or study drug ingredients
  • Uncontrollable fluid accumulation like pleural effusion or ascites
  • HIV infection
  • Active hepatitis B or C (with some exceptions)
  • Active tuberculosis or severe infections
  • Symptomatic heart failure or uncontrolled arrhythmia
  • Uncontrolled high blood pressure
  • Recent arterial or severe venous thromboembolic events
  • Uncontrolled metabolic or non-cancer diseases increasing medical risk
  • Severe liver disease such as decompensated cirrhosis
  • Recent serious gastrointestinal diseases or surgeries
  • Other diseases or conditions affecting safety or study interpretation
  • History of other cancers unless cured or low risk of recurrence
  • Pregnant or breastfeeding women
  • Other conditions judged unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The first hospital of Jilin University

Changchun, Jilin, China, 130000

Actively Recruiting

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Research Team

D

Di Wu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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