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

January 9, 2025 updated by: Zhou Qunfang, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • None Selected
      • Beijing, None Selected, China, 100853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;
  11. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transjugular 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.
Drug: Lenvatinib
12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg
Drug: PD-1 inhibitor
Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)
Procedure: Transjugular 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.
Other Names:
  • TIPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of gastrointestinal hemorrhage
Time Frame: 6 months
atients occur gastrointestinal hemorrhage within 6 months after TIPS.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival (PFS)
Time Frame: 12 months
Progression was defined as progressive disease by independent radiologic review
12 months
Overall survival (OS)
Time Frame: 24 months
OS is the length of time from the date of inclusion until death from any cause.
24 months
Adverse events
Time Frame: 24 months
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations
24 months
Objective response rate (ORR)
Time Frame: 6 months
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Chinese PLA General Hospital

Investigators

  • Study Director: Feng Duan, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liver Projiect 11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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