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

Korea University

Status and phase: Unknown; Phase 4

Conditions: Metastasis; Hepatocellular Carcinoma

Treatments: Drug: Sorafenib; Procedure: transarterial chemoembolization (TACE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03518502

2012AS0313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hepatocellular carcinoma by the European Association for the Study of the Liver (EASL) criteria or pathology
• One or more extrahepatic metastatic lesion by proven radiologically or histologically
• No serious coagulation abnormalities
• Performance status 0 or 1 by Eastern Cooperative Oncology Group(ECOG) criteria
• Child-Pugh score 5 or 6
• Serum creatinine <1.5mg/dL
• Age between 18 ~ 75 years old
• No other life-threatening medical illness

Exclusion criteria

• Patients with main portal vein invasion
• Child-Pugh class B or C
• History of TACE or previous systemic chemotherapy including sorafenib
• Age >75 years old
• Cardiovascular diseases
• History of gastrointestinal bleeding within 2 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

Sorafenib monotherapy arm

Active Comparator group

Description:

The sorafenib monotherapy group receives sorafenib immediately after randomization.

Treatment:

Drug: Sorafenib

TACE-sorafenib sequential therapy arm

Experimental group

Description:

TACE(transarterial chemoembolization )-sorafenib group receives 2\~4 times of TACE before starting sorafenib.

Treatment:

Procedure: transarterial chemoembolization (TACE)

Drug: Sorafenib