Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC (SOURCE)

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transarterial chemoembolization; Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT04143191

FAH-20190358

Details and patient eligibility

About

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primary hepatocellular carcinoma without any treatments.
2. Received curative hepatic resection
3. ECOG score 0-1
4. Child-Pugh grade A
5. Sufficient liver and kidney function

Exclusion criteria

1. Diffused lesions; tumor thrombosis in SMV or IVC.
2. Extra-hepatic metastasis.
3. Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc.
4. Allergic to the contrast agent of TACE
5. Dysfunction of liver, kidney or bone marrow.
6. Concomitant other malignant tumor or HIV infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Sorafenib

Active Comparator group

Description:

Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. If any drug related adverse event occurred, the dosage will be reduced.

Treatment:

Drug: Sorafenib

Sorafenib plus TACE

Experimental group

Description:

Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. TACE will be performed on the fourth day after randomization. If any drug related adverse event occurred, the dosage will be reduced.

Treatment:

Drug: Sorafenib

Procedure: Transarterial chemoembolization