Gemcitabine + Oxaliplatin +Nab-paclitaxel in Subjects With Advanced Biliary Tract Cancer
Status:
Recruiting
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
Summary
The objective of the study is to determine a new combination of drug that improves the
outcome in patients with advanced (unresectable or metastatic) BTC. The primary objective of
the phase I part of the study is to determine the maximum tolerated dose (MTD) of the
combination gemcitabine plus oxaliplatin plus nab-paclitaxel, established in the first cycle
of therapy, in order to determine the recommended phase II dose (RP2D).
The primary objective of the phase II is to determine activity of GEMOX plus nab-paclitaxel.
The secondary objectives of the study consist in to better define the safety profile and the
outcome of the study treated population.