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

NCT06717763•Sun Yat-sen University

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.

Eligibility

Age

16 - 74 years

Sex

ALL

Healthy Volunteers

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

•\-

Locations (1)

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

January 1, 2017

Primary Completion Date

July 1, 2023

Completion Date

September 30, 2024

Last Updated

December 5, 2024

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

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RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease