Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer

Phase 2 Completed 28 enrolled Mayo Clinic National Comprehensive Cancer Network · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well trifluridine/tipiracil and irinotecan work in treating patients with biliary tract cancer that has spread to other places in the body (advanced) and has not responded to treatment (refractory). Trifluridine/tipiracil and irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Timeline

Start: 2019-10-18
Primary completion: 2021-08-13
Completion: 2021-08-13

Outcome

Met primary endpoint

paper PFS16 rate was 37% (10/27; 95% CI: 19%-58%), thereby meeting the criteria for success for the primary endpoint. PMID 37339254 ↗

Publications

Tella SH, Foster N, Qian S, Nguyen T, Borad MJ, McWilliams RR, Alberts SR, Wee Ma W, Chakrabarti S, Fruth B, Wessling J, Hartgers M, Washburn L, Fernandez-Zapico ME, Hogenson TL, Pitot H, Jin Z, Mahipal A. Phase II Trial of Trifluridine/Tipiracil Plus Irinotecan in Patients with Advanced, Refractory Biliary Tract Carcinoma. Oncologist. 2023 Oct 3;28(10):917-e966. doi: 10.1093/oncolo/oyad144.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	180 mg/m2	Intravenous
Subject	Trifluridine/Tipiracil	Unknown	25 mg/m2	Oral