Colorectal Cancer Trial, Recruiting NCT04643041 Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT04643041
Recruiting Not Applicable

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:

  • You have been diagnosed with rectal cancer (a specific type called adenocarcinoma), confirmed by a tissue sample test
  • Your tumour has a specific genetic feature called "dMMR" or "MSI-H," identified through laboratory testing of your tumour tissue
  • Scans show your tumour is located in the lower part of the rectum (below a certain internal boundary called the peritoneal reflection)
  • Your cancer has not spread to distant parts of the body, based on CT and MRI scans
  • You have no blockage in your bowel, or any blockage has already been relieved by a temporary colostomy (a surgical opening in the abdomen to redirect the bowel)
  • You have never had surgery on your rectum before
  • You have never had chemotherapy or radiation therapy before
  • You have never received immunotherapy (such as anti-PD-1 or similar drugs) or other biological treatments (such as monoclonal antibodies) before
  • After initial treatment within the trial, scans and tests show your tumour has completely responded (disappeared) — confirmed by imaging and tissue biopsy
  • You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • You have a serious heart condition, such as an irregular heartbeat requiring certain medications, significant coronary heart disease, a heart attack within the last 6 months, or moderate-to-severe heart failure
  • You have high blood pressure that cannot be controlled with medication
  • You have HIV, or currently have active hepatitis B or C infection
  • You have active tuberculosis (TB), are currently being treated for TB, or were treated for TB within the past year
  • You have another serious active infection
  • Your cancer has spread to areas outside the pelvis
  • You have significant blood disorders or major organ problems (confirm with trial site)
  • You have previously had radiation therapy to the pelvis or abdomen
  • You have more than one colorectal cancer or more than one primary cancer at the same time
  • You have epilepsy that requires treatment with steroids or anti-epilepsy medication
  • You have had another type of cancer within the past 5 years
  • You have a history of serious drug misuse, or psychological or social conditions that could affect your participation or the study results
  • You have an active autoimmune disease (such as lung inflammation, eye inflammation, bowel inflammation, liver inflammation, kidney inflammation, thyroid problems, or asthma requiring an inhaler) or a history of such conditions
  • You have received any vaccine in the 4 weeks before joining the trial
  • You regularly take immune-suppressing drugs or corticosteroids (steroid tablets) above a low dose threshold
  • You are known or suspected to be allergic to any of the drugs used in this trial
  • You have any unstable health condition that could put your safety at risk during the trial
  • You are pregnant, breastfeeding, or able to have children but not using contraception
  • You do not wish to sign the consent form

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 9 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Jianping Wang, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Phone: +8613926451242

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
Not Applicable
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Registry
ClinicalTrials.gov
Start date
1 January 2021
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

1 year DFS 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: 9 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