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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

irinotecan hydrochloride. The hydrochloride salt of a semisynthetic derivative of camptothecin, a cytotoxic, quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata. Irinotecan, a prodrug, is converted to a biologically active metabolite 7-ethyl-10-hydroxy-camptothecin (SN-38) by a carboxylesterase-converting enzyme. One thousand-fold more potent than its parent compound irinotecan, SN-38 inhibits topoisomerase I activity by stabilizing the cleavable complex between topoisomerase I and DNA, resulting in DNA breaks that inhibit DNA replication and trigger apoptotic cell death. Because ongoing DNA synthesis is necessary for irinotecan to exert its cytotoxic effects, it is classified as an S-phase-specific agent. NCI Drug Dictionary

trifluridine and tipiracil hydrochloride. An orally bioavailable combination agent composed of the cytotoxic pyrimidine analog trifluridine (5-trifluoro-2'-deoxythymidine or TFT) and a thymidine phosphorylase inhibitor (TPI) tipiracil hydrochloride, in a molar ratio of 1.0:0.5 (TFT:TPI), with potential antineoplastic activity. After oral administration of TAS-102, TFT is phosphorylated to the active monophosphate form TF-TMP, which binds covalently to the active site of thymidylate synthase, thereby reducing the nucleotide pool levels required for DNA replication. Furthermore, the triphosphate form TF-TTP can be incorporated into DNA, which induces DNA fragmentation and leads to the inhibition of tumor growth. TPI exhibits a dual effect: 1) an anti-angiogenic effect mediated through the inhibition of thymidine phosphorylase, which plays important role in nucleotide metabolism and a variety of development processes, including angiogenesis, 2) increased bioavailability of the normally short-lived antimetabolite TFT by preventing its degradation into the inactive form trifluorothymine (TF-Thy). The synergistic effect of the components in TAS-10 may demonstrate antitumor activity in 5-FU-resistant cancer cells. NCI Drug Dictionary

bevacizumab. A recombinant humanized monoclonal antibody directed against the vascular endothelial growth factor (VEGF), a pro-angiogenic cytokine. Bevacizumab binds to VEGF and inhibits VEGF receptor binding, thereby preventing the growth and maintenance of tumor blood vessels. NCI Drug Dictionary

Treatments listed in the registry

• Liposomal irinotecan (Drug): 50mg/m2 IV on days 1 and 15
• TAS102 (Drug): 35mg/m2 PO BID on days 1-5 and 15-19
• Bevacizumab (Drug): 5mg/kg IV on days 1 and 15

Na · Single Group · masking: None

Main goals

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

Other goals

• Objective Response Rate (ORR)
• Number of Participants Experiencing Grade 3 and 4 Toxicities
• Summary of Grade 3 and 4 Toxicities by Count of participants
• Efficacy of irinotecan measured by PFS for patients with and without irinotecan containing regimens

Planned enrollment: 50 (estimated).

• University of Wisconsin Carbone Cancer Center, Madison, Wisconsin

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05854498
• NCI Drug Dictionary: C1381
• NCI Drug Dictionary: C102554
• NCI Drug Dictionary: C2039

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 14, 2026. Public record; not medical advice.