Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:20 PM
Study NCT ID:
NCT07400302
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery
Sponsor:
The First Hospital of Jilin University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: