Phase 3 Colorectal Cancer Trial, Recruiting NCT05194878 Sponsor: Sun Yat-sen University Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT05194878
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with cancer or high-grade pre-cancerous changes in the colon (located higher up in the large bowel, not the lower rectum), confirmed by a tissue sample and/or clear imaging scans.
  • People whose tumour has a specific genetic profile — tested through a laboratory process on tumour tissue — showing it does not have a feature called "mismatch repair deficiency" or a related marker called "MSI-H" (confirm with trial site for exact test result requirements).
  • People whose scans show the cancer has grown significantly into or beyond the bowel wall, or into nearby tissues or organs, based on a CT scan taken before surgery.
  • People who had a bowel blockage caused by the tumour, but only after the blockage has been successfully relieved by a temporary bowel diversion procedure, and once they have recovered sufficiently.
  • People with blood test results showing adequate white blood cell and platelet counts. Low red blood cell levels are not automatically disqualifying, but the trial site would look to correct this before treatment begins.
  • People whose kidney function blood tests are within an acceptable range (below 1.5 times the upper limit of normal).
  • People whose liver function blood tests — specifically bilirubin and ALT — are within an acceptable range (below 1.5 times the upper limit of normal).
  • People with a good general level of fitness and ability to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1, meaning fully active or restricted only in strenuous activity).

Who may not be able to join:

  • People for whom the treating medical team recommends radiotherapy as part of their care.
  • People with clear evidence that the cancer has spread to distant parts of the body or to the lining of the abdominal cavity.
  • People whose tumour tissue testing shows a genetic profile described as "mismatch repair deficient" or "MSI-Low/MS-Stable" (confirm with trial site).
  • People who have peritonitis — a serious infection or inflammation of the abdominal lining — caused by a tumour that has perforated (made a hole in) the bowel.
  • People who still have an unrelieved bowel blockage caused by the tumour.
  • People with serious ongoing health conditions that are not well controlled, such as inflammatory bowel disease, severe heart-related chest pain, or a heart attack within the past six months.
  • People with any other serious medical condition that the medical team believes would make it unsafe to undergo pre-surgery treatment or surgery itself.
  • People who have had another cancer diagnosed within the past five years, with the exception of certain low-risk skin cancers, very early-stage cancers confined to one spot, or cancers with a very low chance of returning (less than 5% recurrence risk).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 December 2021
Est. completion
1 December 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Disease-free survival

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov