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TIPS Plus Cadonilimab in Advanced HCC With Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study

Hepatocellular Carcinoma Clinical Trial

Official title:
TIPS Plus Cadonilimab (a PD-1/CTLA-4 Bispecific Antibody) in Advanced Hepatocellular Carcinoma With Tumor Thrombosis-associated Portal Hypertension: a Prospective, Single-arm, Phase II Study

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.

Clinical Trial Description

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension. Subjects who meet the admission criteria will be treated with Cadonilimab after TIPS until disease progression, intolerable toxicity, death, withdrawal of the patient, or the researchers determined that the drug must be discontinued. The primary outcome measure is to evaluate the objective response rate (ORR). The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS). This study also aims to assess the safety and adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05882370
Study type Interventional
Source Sun Yat-sen University
Contact Fei Gao, M.D.,Ph.D.
Phone 86-13760869828
Email gaof@sysucc.org.cn
Status Not yet recruiting
Phase Phase 2
Start date July 1, 2023
Completion date August 31, 2025
View Details
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