Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma

Summary

This is a prospective, single arm, open label, non-randomized, exploratory, multi-centre pilot study with median progression free survival as primary outcome. In total 28 patients (including 3 calculated drop outs and invalid cases) with advanced cholangiocellular carcinoma after failure of a gemcitabine based first-line therapy will be enrolled at 5 centres. To examine the efficacy of a combination therapy of Trifluridine/Tipiracil and Irinotecan in patients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine treatment. The study will be accompanied by a translational research program: Before treatment and after each radiological tumor assessment (Q6W) blood and stool will be collected and extensive panels of biomarkers will be accessed.

Timeline

Start

2021-10-28

Primary completion

2024-01-08

Completion

2024-01-08

Publications

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• Kehmann L, Berres ML, Gonzalez-Carmona M, Modest DP, Mohr R, Wree A, Venerito M, Strassburg C, Keitel V, Trautwein C, Luedde T, Roderburg C. Study protocol of an open-label, single arm phase II trial investigating the efficacy and safety of Trifluridine/Tipiracil combined with irinotecan as a second line therapy in patients with cholangiocarcinoma (TRITICC). BMC Cancer. 2023 May 22;23(1):470. doi: 10.1186/s12885-023-10972-6.

Drugs

Indications