RecruitingNot ApplicableNCT06624098

Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study


Sponsor

Sun Yat-sen University

Enrollment

22 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether performing TIPS (transjugular intrahepatic portosystemic shunt — a procedure that relieves pressure in the liver's blood vessels) early — within 72 hours of an emergency bleeding episode — improves outcomes for people with advanced liver cancer that has blocked the main portal blood vessels. All patients also receive standard drug therapy (lenvatinib and PD-1 immunotherapy). **You may be eligible if...** - You have been diagnosed with primary liver cancer (hepatocellular carcinoma) - The cancer has blocked the main portal blood vessels (PVTT grade III–IV) - You had an emergency endoscopy to stop bleeding, and TIPS was done within 72 hours - Your cancer has spread to no more than 5 sites in no more than 2 organs - You are on lenvatinib and PD-1 immunotherapy as your first treatment - Your liver function is Child-Pugh class A or B **You may NOT be eligible if...** - You have had other cancers - Your liver function is severely compromised (Child-Pugh C) - You have uncontrolled infections or serious blood clotting problems 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

PROCEDUREEarly TIPS

TIPS was performed within 72 hours after the endoscopic hemostasis.


Locations(2)

Chinese PLA General hospital

Beijing, Beijing Municipality, China

Chinese PLA General hospital

Beijing, Beijing Municipality, China

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NCT06624098


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