Phase 3 Colorectal Cancer Trial, Recruiting NCT05984485 Sponsor: Sun Yat-sen University Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT05984485
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 aged 18 to 75 years who have been newly diagnosed
  • People whose rectal cancer has been confirmed by a pathology test (tissue sample analysis) as a type called adenocarcinoma
  • People whose tumor is located within 15cm of the anal opening
  • People whose MRI scan shows a specific category of locally advanced rectal cancer (classified as T1-3bN1-2, T3aN0, or T3bN0), with no spread to the anal sphincter muscle, clear margins around the rectum, no signs of cancer spreading into nearby blood vessels, and no cancer nodules (confirm with trial site)
  • People who have no signs of the cancer returning elsewhere in the body or spreading to distant organs
  • People who have only one rectal tumor, with no additional colorectal cancers present at the same time
  • People who are in sufficient overall health to safely undergo surgery and pre-surgery chemotherapy, including having adequately functioning heart, lungs, liver, and kidneys
  • People for whom the treating surgeon has assessed that sphincter-preserving surgery (surgery that keeps the anal muscle intact) is possible
  • People who are willing to take part and provide written consent, along with their family

Who may not be able to join:

  • People who currently have, or have previously had, another type of cancer
  • People who need emergency surgery due to a blocked, perforated, or bleeding bowel
  • People whose tumor has grown into the external sphincter muscle, the pelvic floor muscles, or surrounding organs in a way that would require removal of those organs
  • People who had poor bowel control or fecal incontinence before surgery
  • People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or a condition called familial adenomatous polyposis
  • People who have recently been diagnosed with another cancer (confirm with trial site for timeframe)
  • People whose general health is rated at a certain low level using standard medical scoring tools (ASA grade IV or above, or ECOG score above 2) (confirm with trial site)
  • People with serious liver or kidney problems, significant heart or lung conditions, blood clotting disorders, or other serious health conditions that make surgery unsafe
  • People with a history of severe mental illness
  • Women who are pregnant or breastfeeding
  • People with an infection that is not under control before surgery
  • People who, in the treating doctor's judgment, have other medical or test-related reasons that make participation unsuitable

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 27 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.

Contact this trial

Principal Investigator: Liang Kang, PhD,MD, Sun yat-sen University, sixth affiliated hospital

Phone: +8613560309975

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 3
Registry
ClinicalTrials.gov
Start date
5 July 2022
Est. completion
1 July 2028

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: 27 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