Study of ctDNA Guided Change in Tx 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.

Trial Details

NCT ID
NCT04920032
Phase
PHASE1
Sponsor
University of California, Irvine
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • TAS-102
  • Irinotecan
  • Standard Treatment
  • Signatera MRD ctDNA Assay
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Patients must have histologically or cytologically confirmed adenocarcinoma of the colon (high rectal cancer is eligible if resected and no radiati…
  • Must have Stage II, Stage III, or Stage IV colorectal cancer after curative intent resection eligible for adjuvant doublet chemotherapy for at leas…
  • Must have ctDNA positive assay (tested by Signatera MRD assay) after at least 3 months of perioperative chemotherapy
  • Age ≥ 18 years

For full eligibility, visit ClinicalTrials.gov.

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