Phase 3 Colorectal Cancer Trial, Recruiting NCT05954078 Sponsor: Fudan University Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT05954078
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 colorectal adenocarcinoma (a type of bowel cancer) confirmed through laboratory testing of tissue samples
  • People who have had surgery to fully remove their primary bowel cancer tumour
  • People whose cancer is classified as high-risk Stage II or Stage III colorectal cancer based on established international staging guidelines
  • People whose blood test showed a positive result for a specific cancer marker called ctDNA methylation, taken 5–7 days after surgery and before joining the trial
  • People who have no signs of cancer returning, as confirmed by CT scans of the chest, abdomen, and pelvis
  • People aged 18 to 80 years old, of any gender
  • People who are expected to live for more than 12 months
  • People who are generally well enough to carry out light activity and care for themselves (confirm with trial site for exact fitness level required)
  • People whose bone marrow, heart, lungs, liver, and kidneys are working well enough to meet specific blood test results, including acceptable levels of blood cell counts, liver function, and kidney function (confirm with trial site for exact values)
  • People who do not have significant diarrhoea or mouth sores at the time of joining
  • People who have given written, informed consent to participate after being fully informed about the trial

Who may not be able to join:

  • People who received cancer treatment (such as chemotherapy or radiation) before their surgery
  • People who received a blood transfusion during surgery or within 2 weeks before surgery
  • People for whom required blood samples taken before surgery and 5–7 days after surgery are missing or incomplete
  • Women who are pregnant, breastfeeding, or capable of becoming pregnant and not using adequate contraception
  • People who have had another type of cancer within the past 5 years, with the exception of certain fully treated cancers such as early-stage cervical cancer or certain types of skin cancer
  • People with a brain tumour or cancer that has spread to the brain and is not well controlled, especially if it is causing increased pressure in the skull or neurological symptoms
  • People with serious or uncontrolled health conditions, including unstable heart disease, heart failure, or heart attack within the past 6 months; confirmed nerve or psychiatric conditions such as dementia or seizures; severe or uncontrolled infections; or significant bleeding disorders
  • People with seriously reduced function in major organs
  • People who the trial doctor believes should not participate for other medical reasons (confirm with trial site)

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 28 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 August 2023
Est. completion
1 June 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

ctDNA clearance rate

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: 28 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