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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2023-09-15

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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.

Sorafenib plus TACE

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.

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.

Transarterial chemoembolization

Intervention Type PROCEDURE

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.

Interventions

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Sorafenib

Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.

Intervention Type DRUG

Transarterial chemoembolization

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.

Intervention Type PROCEDURE

Other Intervention Names

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TACE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No