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

Hepatocellular Carcinoma Clinical Trial

— SOURCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143191
• Other study ID #: FAH-20190358
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2019
• Est. completion date: September 15, 2023

Study information

• Verified date: March 2020
• Source: Sun Yat-sen University
• Contact: Ming Kuang, MD, PhD.
• Phone: 008687755766
• Email: kuangm[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Procedure:
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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