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
Colon Cancer 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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