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Recruiting NCT06624098

Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

No phase Interventional Advanced Hepatocellular Carcinoma Variceal Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early TIPS.
Who it may be relevant to
Registry conditions: Advanced Hepatocellular Carcinoma, Variceal Bleeding. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added clinical evidence for this subtype of advanced HCC.

Interventions

  • Procedure Early TIPS
    TIPS was performed within 72 hours after the endoscopic hemostasis.

Primary outcome measures

  • Rates of technical success [Time frame: 3 months]
Secondary outcome measures (5)
  • Rates of gastrointestinal hemorrhage [Time frame: 6 months]
  • Progression-Free-Survival (PFS) [Time frame: 12 months]
  • Overall survival (OS) [Time frame: 12 months]
  • Objective response rate (ORR) [Time frame: 12 months]
  • Adverse events [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
  • presence of PVTT with III-IV grade by Cheng's criteria;
  • having PVTT induced portal hypertension;
  • TIPS was performed within 72 hours after the endoscopic hemostasis;
  • metastases with limited five sites and no more two organs involved;
  • number of Intrahepatic tumors were no more than five;
  • receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
  • classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
  • no history of other malignancies;
  • agreed to participated in this clinical trial;
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Chinese PLA General hospital — Beijing
  • Chinese PLA General hospital — Beijing

Identifiers

NCT: NCT06624098 · Liver Projiect 12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗