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New drug cocktail shows promise for Tough-to-Treat colon cancer

NCT ID NCT05854498

Disease control Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 4 times

Summary

This study is testing whether a combination of three drugs—liposomal irinotecan, TAS102, and bevacizumab—can help people with metastatic colorectal cancer that has not responded to prior treatments. About 50 adults with mismatch repair proficient tumors will receive the drugs in cycles. The main goal is to see how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
liposomal irinotecan, TAS102, and bevacizumab
What this could lead to
If successful, this combination could offer a new treatment option for patients with metastatic colorectal cancer who have not responded to standard therapies.
What could go wrong
This is a small, early-phase trial with only 50 participants, so results may not apply broadly. The combination may cause serious side effects, and it is not yet known if it improves survival.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 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 be ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1. * Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable. * The cancer must be mismatch repair proficient. * Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior anti-EGFR therapy with either cetuximab or panitumumab. If RAS wild-type and HER2 positive then must have had a prior HER2 targeted therapy. Exclusion Criteria: * Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy. * Patients whose cancers possess BRAF V600 mutations are excluded. * Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy. * Patients must not have mismatch repair deficient or microsatellite instability high cancers. * Patients must not have received prior TAS102.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 52792, United States

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