Phase 2 Colorectal Cancer Trial, Recruiting NCT06202001 Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06202001
Recruiting Phase 2

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 confirmed by tissue testing to have a type of bowel cancer called colorectal adenocarcinoma.
  • People whose colorectal cancer has spread to other parts of the body, as confirmed by CT scan and MRI.
  • People who have already received a first round of chemotherapy that included a drug called oxaliplatin, with or without other cancer treatments such as targeted therapy, immunotherapy, or radiotherapy.
  • People aged 18 to 70 years old.
  • People who are in good enough general health to carry out daily activities with little or no limitation (as measured by a standard health scoring tool), and whose health has not noticeably declined in the two weeks before starting the trial.
  • People whose blood and organ function results fall within acceptable ranges, including healthy enough levels of red blood cells, white blood cells, platelets, and normal or near-normal kidney and liver function (confirm with trial site for exact values).
  • People who have read and signed a consent form agreeing to take part.

Who may not be able to join:

  • People whose bowel cancer is a type other than adenocarcinoma, such as squamous carcinoma, neuroendocrine carcinoma, or adenosquamous carcinoma.
  • People who have had a serious allergic reaction to the study drugs irinotecan or trifluridine/tipiracil (TAS-102), or to any of their ingredients — or people whose cancer got worse while they were being treated with irinotecan (note: people whose cancer progressed only during a maintenance phase of treatment may still be considered eligible — confirm with trial site).
  • People who have had a serious allergic reaction to the drug bevacizumab or any of its ingredients.
  • People who are unable to swallow tablets or who have conditions that prevent proper absorption of oral medication.
  • People who have had repeated episodes of bleeding or who needed a blood transfusion in the two weeks before starting the trial.
  • People who have had major surgery within the four weeks before joining the trial (routine tissue biopsies are not included in this restriction).
  • People who have been diagnosed with another cancer within the past five years, with some exceptions for certain low-risk or fully treated cancers such as early cervical cancer, certain skin cancers, early bladder cancer, or well-treated thyroid cancer (confirm with trial site).
  • People who have had serious bowel or digestive problems in the six months before starting the trial, such as a hole in the bowel, bowel blockage, a fistula (an abnormal internal tunnel), ongoing diarrhoea, Crohn's disease, or ulcerative colitis.
  • People with serious heart problems, such as poor heart pumping function, heart failure, severe chest pain, or a history of stroke or heart attack in the past six months.
  • People with blood pressure that remains very high despite treatment, or blood sugar levels that are not well controlled.
  • People with a history of certain serious heart rhythm problems (confirm with trial site for specific conditions).
  • People with active hepatitis B, hepatitis C, syphilis, or HIV infection.
  • People who have had a blood clot in a vein or artery, such as a deep vein thrombosis or a clot in the lungs, within three months before starting the trial (clots related to medical catheters may be exempt — confirm with trial site).
  • People who are currently being treated for tuberculosis, or who have been treated for it within the past 12 months.
  • People with serious lung disease or a history of lung inflammation (pneumonitis).
  • People who have an active infection requiring treatment in the two weeks before starting the trial.
  • People with a history of psychiatric illness related to substance abuse, or a history of drug misuse.
  • People who are pregnant or breastfeeding.
  • People who are able to have children but are unwilling to use contraception during the trial.
  • People with any other serious health condition, abnormal test result, or other concern that the trial doctor considers would make participation unsafe or affect the reliability of the results.

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 22 July 2026
Phase 2: approximately ~30% 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: Yongkun Sun, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phone: +8613141276041

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 2
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Registry
ClinicalTrials.gov
Start date
1 October 2022
Est. completion
30 September 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR)

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: 22 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