Blood test could help pick the right drug for tough colorectal cancers
NCT ID NCT03844620
First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 5 times
Summary
This phase II trial is testing whether a blood test that looks for tumor DNA (ctDNA) can help doctors choose between two standard drugs—regorafenib or TAS-102—for people with advanced colorectal cancer that has stopped responding to other treatments. The study will enroll 100 participants and compare how well the blood test predicts tumor growth and side effects compared to usual care. The goal is to see if this personalized approach leads to better outcomes and fewer unnecessary side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- regorafenib or trifluridine/tipiracil hydrochloride (TAS-102)
- What this could lead to
- If successful, this could show that using a simple blood test to monitor tumor DNA helps doctors choose the right drug at the right time, potentially improving survival and quality of life for people with advanced colorectal cancer.
- What could go wrong
- This is a small, early-phase trial (100 participants) that is not yet recruiting. The approach may not prove better than standard care, and the drugs themselves can cause serious side effects like fatigue, hand-foot skin reactions, and low blood counts.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
100 people
The number who actually took part.
- Started
-
Jan 2019
- Expected to finish
-
Aug 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically or cytologically confirmed colorectal cancer. * Patients must have advanced or metastatic disease with no curative options. * Patients must have radiographically evaluable disease. * Patients must have had at least 2 prior therapies for mCRC (including fluorouracil \[5-FU\], oxaliplatin, irinotecan, bevacizumab; cetuximab/panitumumab \[for RAS wild type (WT) patients\]) and have either progressed on or intolerant to these agents or use of these agents is contraindicated. * Patients must be clinically eligible for either regorafenib or TAS-102 as per their treating physician. * Patients must have a negative serum pregnancy test done less than are equal to 14 days prior to randomization for women of childbearing potential only. Women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation. * Patients must have ability to complete questionnaire(s) by themselves or with assistance. * Patients must have ability to provide informed written consent. * Patients must be willing to return to enrolling institution for follow-up as per study schedule. * Patients must be willing to provide blood samples for correlative studies. * Any of the following: Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception. * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Exclusion Criteria: * Patient who have received prior TAS-102 are eligible to enroll on the study if they can receive regorafenib and vice-versa. Otherwise these patients will be excluded from the study. * Congestive heart failure \> New York Heart Association (NYHA) class 2, unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction less than 3 months prior to randomization. * Ongoing infection \> grade 2 CTCAE version 4.0. * Symptomatic metastatic brain or meningeal tumors unless the patient is \> 3 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to brain lesions at the time of randomization (Note: patient must not be undergoing acute steroid therapy or taper \[chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies\]). * Renal failure requiring hematological or peritoneal dialysis. * Patients unable to swallow oral medications.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Refractory colorectal carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a vaccine stop GI cancers from returning?
- Can we predict and treat cancer wasting better? a new study investigates
- Can a new blood test spot colorectal cancer return earlier?
- Can a Two-Drug combo outsmart resistant colorectal cancer?
- Experimental drug combo targets Hard-to-Treat GI cancers
- Wheat germ supplement studied for immune boost in advanced cancer