Liposomal Irinotecan, TAS102, and Bevacizumab for Metastatic Colorectal Cancer

This study is testing a combination of three drugs: liposomal irinotecan, TAS102, and bevacizumab, for patients with metastatic colorectal cancer that has continued to grow despite previous treatments. The goal is to see if this combination can help control the cancer and improve how long patients live without their cancer getting worse (Progression Free Survival or PFS). You may be able to join if you are at least 18 years old, have metastatic or unresectable colorectal cancer that is mismatch repair proficient, and have a good general health status (ECOG performance 0 or 1). The study is looking for 50 participants, but the current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It aims to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Progression Free Survival, will be measured for up to 2 years.

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NCT05854498

Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Wisconsin, Madison
~50 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:Liposomal irinotecanTAS102Bevacizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over up to 2 years
Metastatic Colorectal Cancer
1 sites across 1 states
Wisconsin1
  • Dustin Deming, MD · PRINCIPAL_INVESTIGATOR · UW Carbone Cancer Center

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Eligibility criteria

Inclusion

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

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.
  • Progression Free Survival (PFS)up to 2 years

    PFS is defined as the time from D1 of treatment with the study combination until the criteria for disease progression is met as defined by RECIST 1.1 criteria or death as a result of any cause.