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Blood test could help pick the right drug for tough colorectal cancers

NCT ID NCT03844620

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.