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
Sun Yat-sen University
42 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, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.
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;
- with or without PVTT induced acute variceal bleeding;
- 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
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.
12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg
Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)
Locations(1)
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NCT06622031