Back to resultsEffect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1
Primary Purpose
Hepatocellular Carcinoma
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sorafenib
S-1
Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- hepatocellular carcinoma after liver transplantation
- Major organ (heart, lung and brain) function was normal
Exclusion Criteria:
- Any active infectious process
- The presence of clinically confirmed extrahepatic metastasis
- Postoperative dysfunction of any organ
Sites / Locations
- First affiliated hospital, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sorafenib
S-1 and Sorafenib
Arm Description
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
Outcomes
Primary Outcome Measures
Time to Recurrence (TTR)
Time to Recurrence
Secondary Outcome Measures
Overall survival (OS)
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02129322
Brief Title
Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1
Official Title
Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1o Prevent the Tumor Recurrence for Hepatocellular Carcinoma After Liver Transplantation: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
patients not enrolled
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
5. Study Description
Brief Summary
The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation
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
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
Arm Title
S-1 and Sorafenib
Arm Type
Experimental
Arm Description
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Primary Outcome Measure Information:
Title
Time to Recurrence (TTR)
Description
Time to Recurrence
Time Frame
within five years after liver transplantation
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival
Time Frame
within the five years after liver transplantation
Other Pre-specified Outcome Measures:
Title
Circulative tumor cell (CTC) level change
Description
Circulative tumor cell
Time Frame
within one year after liver transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hepatocellular carcinoma after liver transplantation
Major organ (heart, lung and brain) function was normal
Exclusion Criteria:
Any active infectious process
The presence of clinically confirmed extrahepatic metastasis
Postoperative dysfunction of any organ
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weijia fang
Organizational Affiliation
First Affiliated Hospital,Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First affiliated hospital, Zhejiang University
City
Hangzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1
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