Recruiting
Phase 2

Liposomal Irinotecan, TAS102, Bevacizumab

Sponsor:

University of Wisconsin, Madison

Code:

NCT05854498

Conditions

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liposomal irinotecan

TAS102

Bevacizumab

Study Details

Brief summary:

This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Study ID

NCT05854498

Start date

Oct 13, 2023

Status verified date

Mar, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Metastatic or Unresectable Colorectal Cancer

Male and females aged 18 years and older with histologically confirmed metastatic or unresectable (not amenable to curative therapy) colorectal cancer.

Interventions

Liposomal irinotecan

50mg/m2 IV on days 1 and 15

TAS102

35mg/m2 PO BID on days 1-5 and 15-19

Bevacizumab

5mg/kg IV on days 1 and 15

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

Locations

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 52792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-04-02.