Phase 4 Colorectal Cancer Trial, Recruiting NCT06090994 Sponsor: Fudan University Condition: Colorectal Cancer
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Phase 4 Colorectal Cancer Trial, Recruiting

NCT06090994
Recruiting Phase 4

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 aged 18 or older, of any gender
  • People who have been diagnosed with colorectal cancer confirmed by laboratory tissue testing, at stage II (TNM classification)
  • People who had surgery to fully remove the colorectal cancer (called R0 resection) within the 12 weeks before enrolling in the trial
  • People who did not receive any treatment before or after their surgery prior to joining the trial
  • People with a general health and activity level rated at 0–2 on the ECOG scale (a medical scoring system for physical functioning — confirm with trial site)
  • People whose situation meets the Chinese clinical guidelines (CSCO 2022) for receiving a single-drug after-surgery treatment called capecitabine
  • People who are alert, able to communicate clearly, and able to read and complete questionnaires
  • People who agree to take part voluntarily and sign a consent form

Who may not be able to join:

  • People whose cancer is located in the lower part of the rectum, within 12 centimetres of the anal opening
  • People who have a history of any other type of cancer
  • People with a known allergy to Huaier granules, or for whom this product is advised to be avoided or used with caution (this applies to the experimental group only)
  • People who are unable to swallow or take oral (by mouth) medications
  • People who are pregnant, breastfeeding, or planning to become pregnant
  • People who have taken Huaier granules, or traditional Chinese medicines with similar uses, in the month before joining the trial (examples listed in the trial documents include compound cantharides capsules, cinobufacin capsules, Kangai injection, and Pingxiao tablets — confirm with trial site for a full list)
  • People who are unwilling to attend follow-up appointments
  • People whom the trial researchers consider unsuitable for other 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 16 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Sanjun Cai, PhD, Fudan University

Phone: +8618121299134

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
18 October 2024
Est. completion
1 July 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

3-year disease-free survival rate (DFS)

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: 16 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