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

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sorafenib; Procedure: Transarterial chemoembolization

• Registration Number: NCT04143191
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-15
• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25
• Primary Completion: 2021-09-15
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib plus TACE	Transarterial chemoembolization	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.
Sorafenib	Sorafenib	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.
Sorafenib plus TACE	Sorafenib	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.

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	2 years	Recurrence-free survival indicates the interval between randomization and tumor recurrence or death.\[0-2 years\] Longer RFS time indicates better prognosis.

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years	Overall survival indicates the interval between randomization and death.\[0-2years\]Longer OS time indicates better prognosis.
Severe adverse events	2 years	Incidence rate of severe adverse events. \[0-100%\]. lower rate indicates more safety of the treatment
Quality of life	2 years	Questionnaire score of EORTC-QOL. Higher score indicates better quality of life
Time to recurrence	2 years	Time to recurrence indicates the interval between randomization and tumor recurrence.\[0-2years\]Longer TTR time indicates better prognosis.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China