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PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment

Cholangiocarcinoma, Intrahepatic Clinical Trial

Official title:
PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment: a Single-arm, Phase II Clinical Study

Clinical Trial Summary

The study aims to evaluate the efficacy and safety of PD-L1 antibody combined with the CTLA-4 antibody in patients with advanced ICC who progressed after standard treatment.

Clinical Trial Description

The prognosis of unresectable and metastatic intrahepatic biliary tract cancer (ICC) is extremely poor. The median overall survival of first-line gemcitabine and cisplatin for advanced biliary tumors (including ICC) is only 11.7 months. Currently, there is no standard second-line or third-line treatment for advanced ICC, and there is an urgent need to develop new treatment methods to improve patient survival. Chronic inflammation caused by viral infections and bile duct stones is the most common potential risk factor for ICC. The abnormal immune system plays a key role in the occurrence and development of ICC. The immune checkpoint molecules PD-L1 and CTLA-4 are overexpressed in ICC, and they are obviously heterogeneous, so immunotherapy has potential value. Immune checkpoint inhibitors against PD-1/PD-L1 show a good objective remission rate in advanced biliary tumors (including ICC). CTLA-4 inhibitors combined with PD-1/PD-L1 inhibitors show significant clinical enhancement Role, CTLA-4 inhibitors combined with PD-1/PD-L1 inhibitors have been clinically studied in a number of solid tumors. In this phase II clinical study, we will evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with CTLA-4 monoclonal antibody in patients with advanced ICC who progressed after standard treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04634058
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact shi Guo-ming, MD
Phone +8613916969578
Email shi.guoming@zs-hospital.sh.cn
Status Recruiting
Phase Phase 2
Start date November 1, 2020
Completion date September 2024
View Details
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