Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study
Sun Yat-sen University
22 participants
Oct 1, 2024
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. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.
Eligibility
Inclusion Criteria11
- 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 Criteria7
- 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.
Interventions
TIPS was performed within 72 hours after the endoscopic hemostasis.
Locations(2)
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NCT06624098