NCT03730675

Irradiation Stent Placement Plus TACE for HCC and PVTT

Irradiation Stent Placement Plus Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: A Multicenter Randomized Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Hepatocellular Carcinoma
• Portal Vein Tumor Thrombosis

Interventions

Type	Name	Description
PROCEDURE	Portal irradiation stent placement	The irradiation portal vein stent was designed as two separate parts that consisted of an outer seeds-loaded-stent and an inner self-expandable metallic stent
PROCEDURE	TACE	TACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply.
DRUG	Sorafenib	Sorafenib is a kinase inhibitor drug approved for the treatment of advanced hepatocellular carcinoma.

Timeline

• Start date: 2018-11-10
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2018-11-05
• Last updated: 2018-12-21

Locations

1 site across 1 country: China