NCT03518502

Sorafenib Monotherapy vs. TACE-sorafenib Sequential Therapy for HCC With Metastasis

Comparison of Efficacy Between Sorafenib Monotherapy vs. Transarterial Chemoembolization -Sorafenib Sequential Therapy in Hepatocellular Carcinoma Patients With Extrahepatic Metastasis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Korea University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, addition of transarterial chemoembolization (TACE) may be beneficial for controlling intrahepatic tumour. The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.

Detailed description

Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, transarterial chemoembolization (TACE) which is a standard therapy for intermediate stage may be beneficial for controlling intrahepatic tumour, thereby providing chance of improving survival in HCC patients with EHM. The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM. This study is a prospective randomized controlled study being conducted at 6 tertiary hospitals in South Korea. HCC patients with EHM are being enrolled and randomized into sorafenib monotherapy or TACE-sorafenib sequential therapy group. Patients with main portal vein invasion, Child-Pugh class B or C, and history of TACE or previous systemic therapy are being excluded. The sorafenib monotherapy group receives sorafenib immediately after randomization while the TACE-sorafenib group receives 2\~4 times of TACE before starting sorafenib. Response evaluation are performed every 2 months, and time to progression (TTP), progression free survival (PFS), median survival time (MST), and overall survival (OS) which is the primary outcome measure will be compared.

Conditions

• Hepatocellular Carcinoma
• Metastasis

Interventions

Type	Name	Description
PROCEDURE	transarterial chemoembolization (TACE)	Standard therapy for intermediate HCC, but nor for advanced HCC
DRUG	Sorafenib	Standard therapy for advanced HCC

Timeline

• Start date: 2012-03-01
• Primary completion: 2020-02-28
• Completion: 2022-02-28
• First posted: 2018-05-08
• Last updated: 2018-05-08

Locations

6 sites across 1 country: South Korea