Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether adding trifluridine/tipiracil (TAS-102), which interferes with tumour-cell DNA production, to irinotecan, a drug that damages tumour-cell DNA, can clear minimal residual disease in people whose blood still contains ctDNA—short fragments of tumour DNA—after treatment. The trial uses changes in ctDNA to guide a treatment change in colon cancer that is not yet visible on scans.
The idea is that removing ctDNA-positive disease could reduce the chance that the cancer later becomes detectable or returns, compared with continuing standard treatment without this change. The trial is actually measuring the percentage of patients who remain ctDNA-positive after six cycles or at least three months, rather than whether they live longer.
Worth knowing: This is a small, phase 1b, single-arm trial with no comparison group, and ctDNA clearance is a marker of residual disease rather than proof of longer survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT04920032 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 22 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | University of California, Irvine |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug TAS-102
- Drug Irinotecan
- Combination product Standard Treatment
- Test Signatera MRD ctDNA Assay
What it is measuring
Percentage of ctDNA positivity in treatment cohort after 6 cycles or at least 3 months of adjuvant treatment
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. 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.
2. 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.
3. Must have ctDNA positive assay (tested by Signatera MRD assay) after at least 3 months of perioperative chemotherapy
4. Age ≥ 18 years
5. Performance status: ECOG performance status ≤2
6. Life expectancy of greater than 3 months
7. Adequate organ and marrow function as defined below:
1. leukocytesL ≥ 3,000/mcL
2. absolute neutrophil count: ≥ 1,500/mcL
3. platelets: ≥ 80,000/mcl
4. total bilirubin: within normal institutional limits
5. AST(SGOT)/ALT(SPGT): ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present
6. creatinine: <1.5 X ULN
8. The effects of TAS-102 on the developing human fetus at the recommended therapeutic dose are unknown.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT04920032, registered by University of California, Irvine on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.