RecruitingNot ApplicableNCT06622031

TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT

Transjugular Intrahepatic Portosystemic Shunt Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus: a Multicenter Phase II Study


Sponsor

Sun Yat-sen University

Enrollment

42 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, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether adding a procedure called TIPS (transjugular intrahepatic portosystemic shunt — a connection between blood vessels in the liver to relieve pressure) to standard drug therapy can help patients with advanced liver cancer (hepatocellular carcinoma) that has spread into the main blood vessels of the liver. The drug therapy includes lenvatinib and a PD-1 inhibitor (immunotherapy). **You may be eligible if...** - You have been diagnosed with primary liver cancer (hepatocellular carcinoma) - Your cancer has spread into the main portal blood vessels of the liver (PVTT grade III–IV) - You have high blood pressure in the liver (portal hypertension) caused by the tumor - You have limited spread to other areas (5 or fewer spots across no more than 2 organs) - You are on lenvatinib and PD-1 inhibitor as your first cancer treatment - Your liver function is Child-Pugh class A or B **You may NOT be eligible if...** - You have a history of other cancers - Your liver or blood function is severely impaired - You have severe heart or kidney conditions 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

A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the participants received a diuretic treatment and a salt-limited diet.

DRUGLenvatinib

12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg

DRUGPD-1 inhibitor

Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)


Locations(1)

Chinese PLA General hospital

Beijing, None Selected, China

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NCT06622031


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