Trials / Recruiting
RecruitingNCT04920032
Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas
Proof of Concept Study of ctDNA Guided Change in Treatment for Refractory Minimal Residual Disease in Colon Adenocarcinomas
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Treatment on study will be administered in 14 day cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAS-102 | Given PO |
| DRUG | Irinotecan | Given IV |
| COMBINATION_PRODUCT | Standard Treatment | 6 cycles for a 2-week regimen (infusional 5FU based) and up to 4 cycles for a 3-week regimen (oral capecitabine based) after randomization |
| DIAGNOSTIC_TEST | Signatera MRD ctDNA Assay | To be performed within 6-8 weeks of Cycle 1 Day 1. A Mid-treatment ctDNA is to be completed within 6 - 8 weeks of starting treatment. ctDNA is to also be completed within four weeks after completion of study treatment (+/- two weeks) |
Timeline
- Start date
- 2021-08-26
- Primary completion
- 2027-01-21
- Completion
- 2028-01-21
- First posted
- 2021-06-09
- Last updated
- 2026-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04920032. Inclusion in this directory is not an endorsement.