Surgery Following Immune Checkpoint Inhibitions for Controlled Disease in Recurrent or Metastatic dMMR/MSI-H Colorectal Cancer

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT06717763
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Surgical resection for residual lesions could significantly improve the prognosis in metastatic colorectal cancers (CRCs) after systemic treatments, yet the necessity of resecting residual lesions after immune checkpoint inhibitions (ICIs) remains controversial in mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) diseases. We retrospectively enrolled recurrent or metastatic dMMR/MSI-H CRCs who received surgerys from Sun Yat-sen University Cancer Center. Patients without disease progression after at least 2 cycles of ICIs were included. Demographic and clinicopathological data were collected and analyzed. Relapse-free survival (RFS) after surgery were analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2023-07-01
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-01
• Last Update Submitted: 2024-12-01
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. pathologically confirmed CRC with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)20;
2. definite pathological or radiological evidence of recurrent or distant metastasis;
3. received at least 2 courses of ICIs;
4. confirmed as dMMR by immunohistochemical method or MSI-H by polymerase chain reaction or next-generation sequencing;
5. receiving therapeutic surgical treatment for residual lesions or tumor sites and achieving no evidence of disease (NED) ;
6. no progression within the duration of preoperative ICIs

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	up to 5 years	defined as the time from randomization to the first appearance of one of the following: primary tumor recurrence, or death without cancer event; or censored at date of last follow-up
Overall Survival	up to 5 years	defined as the time from randomization to death from any cause. Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive

Trial Locations

Locations (1)

Sun Yat-sen University, Cancer Center; 🇨🇳 Guangzhou, Guangdong, China