Hepatocellular Carcinoma Clinical Trial
Official title:
Irradiation Stent Placement Plus Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: A Multicenter Randomized Study
The study is a multicenter, randomized (1:1), open-label, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of portal irradiation stent placement plus TACE compared to sorafenib plus TACE in patients with advanced HCC accompanied by portal vein tumor thrombosis. Patients will be randomized to receive either portal irradiation stent placement plus TACE(Arm A) or Sorafenib plus TACE (Arm B).
The prognosis of HCC with portal vein tumor thrombosis (PVTT) is dismal, with a median
survival of 2.7-4.0 months compared to that of 10.0-24.0 months without PVTT. Therefore, the
presence of PVTT is regarded as a hallmark of advanced HCC and has a high incidence of
39-63%.
PVTT can accompany intrahepatic tumor spread, liver function deterioration, and portal vein
hypertension, and can lead to intractable ascites, variceal rupture, hepatic encephalopathy
and/or death. As recommended by the Barcelona Clinic Liver Cancer (BCLC) group, the current
standard treatment of HCC with PVTT is sorafenib only. However, sorafenib monotherapy does
not achieve satisfactory outcomes, yielding a median survival time of 5.6 to 8.1 months. To
improve the prognosis, transarterial chemoembolization (TACE), surgical resection,
radiotherapy, ablations, and radioembolization have been applied to treat patients with HCC
and PVTT, with improved outcomes reported.
Portal vein stent placement is regarded as a safe and effective technique in relieving portal
hypertension, extending treatment options, and prolonging survival in patients with HCC and
PVTT. However, the reported stent patency period of 3.7 months and survival time of 2.2 to
6.1 months may not be interpreted as satisfactory outcomes, mainly limited by rapid tumor
infiltration and/or subsequent thrombosis formation.
An irradiation stent has been developed and confirmed to be safe and effective in treating
unresectable esophageal cancer. A modified irradiation stent designed for biliary tract
obstruction was subsequently developed and resulted in significantly improved outcomes in a
single-institute randomized, controlled study of patients with malignant biliary obstruction.
This study aims to demonstrate that overall survival on portal irradiation stent placement
plus TACE is superior to overall survival on sorafenib plus TACE in patients with advanced
hepatocellular carcinoma accompanied by portal vein tumor thrombosis. Secondary Objectives
includes 1. To compare time to progression between both treatment groups; 2. To compare
hepatic function between both treatment groups; 3.To compare the disease control rate of the
intrahepatic lesions between both treatment groups; 4.To evaluate and compare the safety and
tolerability of both treatment groups; 5. To compare portal patency both treatment groups.
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