Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04920032

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

Led by University of California, Irvine · Updated on 2026-05-11

22

Participants Needed

1

Research Sites

334 weeks

Total Duration

On this page

Sponsors

U

University of California, Irvine

Lead Sponsor

T

Taiho Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed adenocarcinoma of the colon, including high rectal cancer if resected without radiation needed
  • Stage II, III, or IV colorectal cancer after curative intent surgery, eligible for at least 3 months of adjuvant doublet chemotherapy
  • Positive ctDNA assay after at least 3 months of perioperative chemotherapy
  • Age 18 years or older
  • ECOG performance status of 2 or less
  • Life expectancy greater than 3 months
  • Adequate organ and marrow function including leukocytes 2,000/mcL, absolute neutrophil count 1,500/mcL, platelets 80,000/mcL, normal bilirubin, AST/ALT within specified limits, and creatinine less than 1.5 times upper limit
  • Agreement to use adequate contraception for women of child-bearing potential and men during and for 90 days after therapy
  • Ability to swallow tablets
  • Willingness and ability to sign informed consent
Not Eligible

You will not qualify if you...

  • Major surgery within 4 weeks, or chemotherapy/radiotherapy within 2 weeks before starting treatment
  • Ongoing toxicities from previous cancer therapy other than alopecia not resolved to grade 1 or baseline
  • Receiving other investigational agents
  • Known metastases
  • Allergic reactions to TAS-102, irinotecan, or similar agents
  • Uncontrolled illnesses including active infections, heart conditions, arrhythmias, psychiatric illness, or social situations limiting compliance
  • Prior treatment with TAS-102 or irinotecan within 90 days
  • Other primary cancers within 3 years except certain skin, prostate, or cervical cancers
  • Inability to comply with study and follow-up procedures
  • Pregnancy or nursing due to potential harm to fetus or infant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States, 92868

Actively Recruiting

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Research Team

C

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

U

University of California Irvine Medical

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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