Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Trial Parameters
Brief Summary
This study is being conducted to find out if treatment with gemcitabine, cisplatin, nab-paclitaxel, and cemiplimab can shrink previously inoperable tumors enough for surgery.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of biliary tract adenocarcinoma (intra- or extra-hepatic, and gallbladder) * Locally advanced, unresectable BTC without evidence of distant metastatic disease. Patients with surgically unresectable BTC on diagnostic abdominal CT scan or MRI are eligible to participate in the study. Unresectable, locally advanced, but non-metastatic BTC must be confirmed with the designated site radiologist and surgeon at the treating institution (Appendix 2) and must meet at least one of the following criteria: * Tumor involvement of both hepatic lobes and/or vessels * Vascular invasion of the portal vein or main hepatic artery * For perihilar tumors: bilateral hepatic duct involvement up to secondary radicles * Atrophy of one liver lobe with invasion of contralateral vessel and/or bile duct * Extrahepatic organ tumor invasion, except contiguous involvement of the diaphragm * Inadequate estimated liver remnant after surgery If resectability canno