Phase 3 Colorectal Cancer Trial, Recruiting NCT05201430 Sponsor: Fudan University Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT05201430
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:

  • Your rectal cancer has been assessed by MRI scan and is at a stage where it has grown into or through the rectal wall, or has spread to nearby lymph nodes
  • Your cancer has been confirmed by a tissue sample (biopsy) to be a specific type of rectal cancer called adenocarcinoma
  • You are between 18 and 75 years old
  • Your tumor is close enough to the opening of the bowel that surgeons believe they can remove it while preserving the anus
  • Your tumor appears to be fully removable by surgery
  • You have not previously had chemotherapy, radiotherapy, or local surgical removal to treat your rectal cancer
  • Your recent blood test results (taken within 7 days of starting treatment) meet certain minimum levels for white blood cells, platelets, hemoglobin, liver function, and kidney function (confirm with trial site for exact values)
  • You are considered well enough to undergo surgery
  • You have not had another cancer in the past 5 years, except for certain common skin cancers or very early-stage cancers that have not spread
  • You are expected to live for more than 3 months
  • You are not currently pregnant or breastfeeding, and if you could become pregnant, you are using reliable contraception
  • You are generally able to carry out everyday activities with little or no restriction (confirm with trial site)
  • You are willing and able to understand the study and sign a consent form

Who may not be able to join:

  • You are in the final stages of illness with severe weight loss and physical decline
  • You have significant heart or lung problems, or liver or kidney problems that mean you could not safely have chemotherapy or surgery
  • Your cancer has spread to other parts of the body (metastatic cancer)
  • You have a blockage in your bowel, whether partial or complete
  • You have a known allergy to any of the chemotherapy drugs used in this trial (capecitabine, 5-FU, oxaliplatin, or irinotecan)
  • You are pregnant, breastfeeding, or able to have children but not using adequate contraception
  • You have had a serious heart condition, including a heart attack, within the past 12 months, or have severe nerve, psychiatric, infectious, blood clotting, liver, or other serious conditions (confirm with trial site for full details)
  • You have had another type of cancer in the past 5 years, except for certain common skin cancers or very early-stage cancers
  • You have serious disease affecting major organs such as the heart, kidneys, brain, or lungs

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 2 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
27 August 2021
Est. completion
1 June 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

3-year 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: 2 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