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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Sorafenib; Procedure: Transarterial chemoembolization

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ming Kuang, MD, PhD.; Phone Number: 8576 008687755766; Email: kuangm@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Sorafenib; Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.
Experimental: 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.	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.; Other Names: TACE

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Anticipated): September 15, 2021
• Study Completion (Anticipated): September 15, 2023

Study Registration Dates

• First Submitted: October 26, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: FAH-20190358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No