Back to resultsSorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC (SOURCE)
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sorafenib
Transarterial chemoembolization
Sponsored by
About this trial
This is an interventional prevention trial for Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sorafenib
Sorafenib plus TACE
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival
Overall survival indicates the interval between randomization and death.[0-2years]Longer OS time indicates better prognosis.
Time to recurrence
Time to recurrence indicates the interval between randomization and tumor recurrence.[0-2years]Longer TTR time indicates better prognosis.
Severe adverse events
Incidence rate of severe adverse events. [0-100%]. lower rate indicates more safety of the treatment
Quality of life
Questionnaire score of EORTC-QOL. Higher score indicates better quality of life
Full Information
NCT ID
NCT04143191
First Posted
October 26, 2019
Last Updated
March 23, 2020
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04143191
Brief Title
Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sorafenib plus TACE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.
Intervention Type
Procedure
Intervention Name(s)
Transarterial chemoembolization
Other Intervention Name(s)
TACE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence-free survival
Description
Recurrence-free survival indicates the interval between randomization and tumor recurrence or death.[0-2 years] Longer RFS time indicates better prognosis.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival indicates the interval between randomization and death.[0-2years]Longer OS time indicates better prognosis.
Time Frame
2 years
Title
Time to recurrence
Description
Time to recurrence indicates the interval between randomization and tumor recurrence.[0-2years]Longer TTR time indicates better prognosis.
Time Frame
2 years
Title
Severe adverse events
Description
Incidence rate of severe adverse events. [0-100%]. lower rate indicates more safety of the treatment
Time Frame
2 years
Title
Quality of life
Description
Questionnaire score of EORTC-QOL. Higher score indicates better quality of life
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Kuang, MD, PhD.
Phone
008687755766
Ext
8576
Email
kuangm@mail.sysu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Kuang, Ph.D.
Phone
008687755766
Ext
8576
Email
kuangm@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC
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