Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
Qualifiers
Patients must have histologically or cytologically confirmed adenocarcinoma of the colon (high rectal cancer is eligible if resected and no radiation needed). Other histologies which are treated per NCCN guidelines for adjuvant colon cancer are eligible.
Must have Stage II, Stage III, or Stage IV colorectal cancer after curative intent resection eligible for adjuvant doublet chemotherapy for at least 3 months.
Must have ctDNA positive assay (tested by Signatera MRD assay) after at least 3 months of perioperative chemotherapy
Age ≥ 18 years
Disqualifiers
Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1
All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline
Patients may not be receiving any other investigational agents.
Patients with known metastases.
Trial design
Treatments tested in this trial
- TAS-102
- Irinotecan
- Standard Treatment
- Signatera MRD ctDNA Assay
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, Irvine
Lead sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborator
Natera, Inc.
Collaborator
Source ClinicalTrials.gov