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

Last updated: January 9, 2025
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Cancer

Liver Disease

Digestive System Neoplasms

Treatment

PD-1 inhibitor

Lenvatinib

Transjugular intrahepatic portosystemic shunt

Clinical Study ID

NCT06622031
Liver Projiect 11
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. diagnosis of primary HCC, confirmed histologically or clinically according to thecriteria 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 OncologyGroup (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

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 Design

Total Participants: 42
Treatment Group(s): 3
Primary Treatment: PD-1 inhibitor
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
August 30, 2027

Study 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.

Connect with a study center

  • Chinese PLA General hospital

    Beijing, None Selected 100853
    China

    Active - Recruiting

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