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Study of TAS-102 and Irinotecan for Colon Adenocarcinoma

This study is looking at a new way to treat colon adenocarcinoma (a type of colon cancer) when standard treatments haven't fully cleared up all cancer cells. It's testing a combination of two drugs, TAS-102 and irinotecan, in patients whose cancer has been surgically removed but still show signs of minimal residual disease (MRD) through a special blood test called a ctDNA assay. The goal is to see how many patients become ctDNA negative after 6 cycles or at least 3 months of treatment. You might be able to join if you are 18 or older, have Stage II, III, or IV colon cancer, and have had surgery to remove it. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all 22 participants will receive the same treatment. It is an open-label study, so both you and your doctors will know what treatment you are receiving.
What's involved
You would receive treatment in 14-day cycles. You will have a Signatera MRD ctDNA Assay performed within 6-8 weeks of starting treatment, again mid-treatment, and within four weeks after completing study treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 months after starting treatment.

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NCT04920032

Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, Irvine
~22 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:TAS-102IrinotecanStandard TreatmentSignatera MRD ctDNA Assay

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of ctDNA positivity in treatment cohort after 6 cycles or at least 3 months of adjuvant treatment
Measured over 6 months

Conditions

Colon Adenocarcinoma
Colorectal Cancer

Explore related trials

Colon AdenocarcinomaColorectal CarcinomaCirculating Tumor-Derived DNA Negative

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Farshid Dayyani, MD, PhD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-7883
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 9. Ability to swallow tablets 10. Ability to understand and the willingness to sign a written informed consent.

What this trial measures

  • Percentage of ctDNA positivity in treatment cohort after 6 cycles or at least 3 months of adjuvant treatment6 months

    Percent of patients positive for ctDNA after 6 cycles or at least 3 months months after starting adjuvant treatment will be used to estimate the efficacy of adjuvant trifluridine and tipiracil (TAS102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma. The Signatera MRD ctDNA Assay will be used to measure ctDNA positivity.