Columbia University
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.
The purpose of this study is to combine chemotherapy that has previously been shown to have activity in patients with biliary tract cancer with a drug that stimulates the body's immune system against cancer cells (immunotherapy). Previously, the combination of gemcitabine and cisplatin with immunotherapy has been shown to prolong life in patients with advanced biliary tract cancer. Adding nab-paclitaxel, another chemotherapy, to gemcitabine and cisplatin, has also been shown to prolong life in some patients with advanced biliary tract cancer. However, all four of these drugs have not before be…
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 lob…
intravenous 300mg
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