Phase 2 Colorectal Cancer Trial, Recruiting NCT05343013 Sponsor: M.D. Anderson Cancer Center Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT05343013
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:

  • You have been diagnosed with colorectal cancer that was confirmed through a tissue sample (biopsy)
  • You have had surgery to remove your colorectal cancer (with no cancer left behind) at stage II, III, or IV, and have finished all planned treatments aimed at curing the cancer, including at least 3 months of chemotherapy containing a drug called oxaliplatin
  • You have no clear signs of cancer showing up on scans or imaging taken within about 4 weeks of a positive ctDNA blood test
  • A special blood test (called a ctDNA or "liquid biopsy" test) has detected tiny traces of cancer DNA in your blood, suggesting a small amount of cancer may remain even though scans appear clear
  • Your blood test results show your organs (including kidneys, liver, and bone marrow) are working well enough to safely take part in the trial
  • You are generally well enough to carry out everyday activities with little or no limitation (confirmed by your doctor using a standard health scale)
  • You are 18 years of age or older
  • You are able to understand and are willing to sign a consent form agreeing to take part
  • You are willing to use effective contraception during the study and for 7 months after the last dose of the study drug (this applies to both women who could become pregnant and men whose partners could become pregnant)

Who may not be able to join:

  • You currently have another active cancer (besides colorectal cancer) that could interfere with the blood test results
  • You have significantly abnormal levels of certain minerals in your blood (such as potassium, calcium, or magnesium), as judged by the study doctor
  • You have serious ongoing health conditions, such as severe autoimmune disease or major heart or blood vessel problems, that could affect your ability to safely take part
  • You are still experiencing significant side effects (grade 2 or higher) from previous treatments, apart from hair loss or nerve-related symptoms (tingling/numbness)
  • You have any other medical condition, abnormal test result, or health issue that the study doctor believes could make the trial unsafe for you, affect the results, or interfere with the study drug
  • You have a known allergy or sensitivity to the study drugs or their ingredients, or your doctor believes you may be at risk of a serious allergic reaction
  • You are currently pregnant or breastfeeding
  • You are unable to swallow tablets or pills, or have a condition that may prevent your body from properly absorbing the study medication
  • You are currently taking part in another clinical trial involving an experimental treatment

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 15 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: Alisha Bent, MD, M.D. Anderson Cancer Center

Phone: (713) 745-2744

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
Registry
ClinicalTrials.gov
Start date
6 June 2022
Est. completion
15 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy.

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: 15 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