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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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

\-

Minimum Eligible Age

16 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pei-Rong Ding

MD, Ph D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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B2020-064-Y01

Identifier Type: -

Identifier Source: org_study_id