RecruitingPhase 2NCT05882370

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

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


Sponsor

Fei Gao

Enrollment

30 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for liver cancer that has blocked blood flow in a major vein (portal vein tumor thrombosis). It combines a procedure to reroute blood flow through the liver with an immunotherapy drug called cadonilimab. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver cancer (hepatocellular carcinoma) with portal hypertension caused by tumor in the portal vein - Your cancer is advanced (BCLC stage C) but your liver function is still relatively preserved - You have not previously received targeted therapy or immunotherapy - You are in good general health (ECOG score 0–1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your liver is very severely damaged (Child-Pugh score above 13) - You have had certain serious heart, liver, or blood abnormalities - You have autoimmune diseases or are on immunosuppressive medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab

Patients were treated with TIPS plus Cadonilimab (10mg/kg, intravenously, d1, Q3W) to a maximum total cycle of 18 unless any evidence of disease progression or unacceptable side effects.

PROCEDUREtransjugular intrahepatic portosystemic shunt (TIPS)

transjugular intrahepatic portosystemic shunt (TIPS)


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05882370


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