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

Study Overview
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Brief Summary
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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.

Official Title
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Sorafenib Plus Transarterial Chemoembolization Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced Hepatocellular Carcinoma: A Phase 3, Multicenter, Randomized Controlled Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Sorafenib
* Procedure: Transarterial chemoembolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary hepatocellular carcinoma without any treatments. Received curative hepatic resection ECOG score 0-1 Child-Pugh grade A Sufficient liver and kidney function Exclusion Criteria: Diffused lesions; tumor thrombosis in SMV or IVC. Extra-hepatic metastasis. Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc. Allergic to the contrast agent of TACE Dysfunction of liver, kidney or bone marrow. Concomitant other malignant tumor or HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sorafenib<br>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. | Drug: Sorafenib<br>* Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.<br>|
| Experimental: Sorafenib plus TACE<br>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. | Drug: Sorafenib<br>* Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.<br>Procedure: Transarterial chemoembolization<br>* TACE including conventional TACE (cTACE) and DEB-TACE. Treatment choices are according to the specific condition of each patient and the experience of interventional radiologists.<br>* Other names: TACE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | Recurrence-free survival indicates the interval between randomization and tumor recurrence or death.[0-2 years] Longer RFS time indicates better prognosis. | 2 years | 

Secondary Outcome Measures

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