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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06717763

Enrollment

Registered

2024-12-05

Start date

2017-01-01

Completion date

2024-09-30

Last updated

2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

16 Years to 74 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results