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NCT06717763Completed

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

Source: ClinicalTrials.gov · Last updated 5 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
40 (actual)
First submitted
1 Dec 2024
Start date
1 Jan 2017
Primary completion date
1 Jul 2023
Lead sponsor
Sun Yat-sen University
NCT number
NCT06717763

What you commit to

  • Study type: Observational
  • Participants enrolled: 40
  • From 1 Jan 2017 to the primary completion date, 1 Jul 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \-

Who the study is looking for

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

Age in the registry: 16 years to 74 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.