RecruitingPhase 2NCT06646198

TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension

Transjugular Intrahepatic Portosystemic Shunt (TIPS) Plus Half-dose Donafenib (a Kind of Anti-angiogenesis Agents) in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension: a Prospective, Single-arm, Phase II Study. (DoTH Study)


Sponsor

Fei Gao

Enrollment

40 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus half-dose donafenib (a kind of anti-angiogenesis agents) 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 whether combining a procedure called TIPS (a shunt placed in the liver to relieve pressure in the blood vessels) with a low dose of donafenib (a targeted cancer drug) can improve outcomes in patients with advanced liver cancer and serious complications from high pressure in the portal vein. **You may be eligible if...** - You are between 18 and 75 years old - You have pathologically confirmed liver cancer (hepatocellular carcinoma) with at least one measurable tumor - Your cancer is at an advanced stage with a tumor thrombus causing high portal vein pressure - You have not received any prior local or systemic cancer treatments - You have complications from portal hypertension such as gastrointestinal bleeding, ascites (fluid buildup), or pleural effusion - Your liver and organ function meet required levels **You may NOT be eligible if...** - You have received prior local or systemic cancer treatment - Your liver function is very poor (Child-Pugh score above 13) - You are pregnant or breastfeeding - Your blood counts or organ function fall below required thresholds 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

PROCEDURETransjugular intrahepatic portosystemic shunt (TIPS)

Perform transjugular intrahepatic portosystemic shunt under the guidance of DSA

DRUGDonafenib

Half-dose donafenib, 100mg BID P.O. unless any evidence of disease progression or unacceptable side effects.


Locations(1)

Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06646198