Intrahepatic Cholangiocarcinoma by AJCC V8 Stage Clinical Trial
Official title:
Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma: A Exploratory Clinical Trial
This study is designed to observe and evaluate the safety and the efficacy of the anti-programmed-death-1 antibody (anti-PD-1) Triprilumab in combination with chemotherapy of Gemcitabine PLUS Cisplatin in patients who were advanced intrahepatic cholangiocarcinoma with no chance for primary surgery.
Intrahepatic cholangiocarcinoma, also known as intrahepatic cholangiocarcinoma, is derived
from intrahepatic bile duct epithelial cells, the second most common primary liver malignant
tumor in china. but most (60% -70%) patients is diagnosed at the advanced stage . Gemcitabine
plus cisplatin is the standard first-line advanced treatment recommended in international and
domestic guidelines, but the treatment effect remains to be improved.
The clinical benefits of immune therapies for HCC are emerging. Early clinical data already
show the safety of immune checkpoint inhibition. This study is to analyze the safety and
efficacy of immunotherapy Triprilumab Injection combined with Gemcitabine Injection plus
Cisplatin Injection in patients with advanced intrahepatic cholangiocarcinoma.
Patients who were aged 18 to 80 years with a histological or cytological diagnosis of
intrahepatic cholangiocarcinoma，locally advanced or multiple liver metastases, including
postoperative occurrence, will be enrolled in this trial.
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