Clinical trials /

TASIRI for Refractory MRD in Colon Adenocarcinomas

RecruitingPhase 1InterventionalNCT04920032 ↗

This is a Phase Ib, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.

Sponsor
University of California, Irvine
Planned enrollment
22 participants
Start date
August 26, 2021
Primary completion
January 21, 2027 (est.)
Minimum age
18 Years
Interventions
TAS-102, Irinotecan, Standard Treatment, Signatera MRD ctDNA Assay

Official title: Proof of Concept Study of ctDNA Guided Change in Treatment for Refractory Minimal Residual Disease in Colon Adenocarcinomas

This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.

Primary Objective:

  1. 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

Key Eligibility Criteria

  • Patients with confirmed Stage II-IV colon adenocarcinoma
  • Patients must:
    • be eligible for adjuvant doublet chemotherapy for at least 3 months
    • have ctDNA positive assay after at least 3 months of perioperative chemotherapy

Drug: TAS-102

Drug: Irinotecan

See ClinicalTrials.gov for more details:

Study Record

Where this trial is offered

  • Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, California
    Recruiting

Status, sites, and study facts from ClinicalTrials.gov, last posted May 11, 2026 and refreshed here September 5, 2026.View the full record for NCT04920032.