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TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT | Clinical Trials | Clareo Health

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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

NCT06622031•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Detailed Description

Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. In this study, the investigators explore the TIPS combined with Lenvatinib and PD-1 inhibitor for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus. The investigators aim to add clinical evidence for this subtype of advanced HCC.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
•2. presence of PVTT with III-IV grade by Cheng's criteria;
•3. having PVTT induced portal hypertension;
•4. with or without PVTT induced acute variceal bleeding;
•5. metastases with limited five sites and no more two organs involved;
•6. Number of Intrahepatic tumors were no more than five;
•7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
•8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
•9. no history of other malignancies;
•10. agreed to participated in this clinical trial;
+1 more criteria

Exclusion Criteria

•1. recurrent HCC;
•2. PVTT at I-II grade by Cheng's criteria;
•3. age \< 18 years or \> 75 years;
•4. advanced HCC with more than five metastases;
•5. Number of Intrahepatic tumors were more than five;
•6. no response to Lenvatinib;
•7. life expectancy less than 3 months.

Locations (1)

Chinese PLA General hospital

Beijing, None Selected, China

Key Dates

Start Date

October 1, 2024

Primary Completion Date

December 1, 2026

Completion Date

August 30, 2027

Last Updated

January 13, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatocellular CarcinomaPortal Vein Tumor ThrombusSystemic Therapy

Interventions

Transjugular intrahepatic portosystemic shunt

PROCEDURE

Lenvatinib

DRUG

PD-1 inhibitor

DRUG

Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115 zhouqun988509@163.com

Feng Duan, MD

CONTACT

86 13910984586 duanfeng@vip.sina.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

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