Back to resultsSorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Primary Purpose
Liver Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sorafenib
Best Supportive Care
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Sorafenib, Hepatocellular carcinoma, Best supportive care, Survival
Eligibility Criteria
Inclusion Criteria:
- pathological or cytological confirmed advanced hepatocellular carcinoma
- 18 years to 80 years
- liver function Child-Pugh class B
- BCLC stage B or C
- estimated life time 2 months or longer
Exclusion Criteria:
- previous target therapy
- allergy to Sorafenib
- Uncontrolled Bleeding or diarrhea
- eligible for locoregional treatment
Sites / Locations
- Qingdao Central Hospital, Qingdao Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
sorafenib
Best Supportive Care
Arm Description
sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
treatment mainly on nutrition and symptoms control
Outcomes
Primary Outcome Measures
progression free survival and overall survival
Secondary Outcome Measures
response rate
Full Information
NCT ID
NCT01932385
First Posted
August 22, 2013
Last Updated
February 13, 2018
Sponsor
Qingdao Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01932385
Brief Title
Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Official Title
Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (undefined)
Primary Completion Date
January 30, 2016 (Actual)
Study Completion Date
July 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Sorafenib, Hepatocellular carcinoma, Best supportive care, Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sorafenib
Arm Type
Experimental
Arm Description
sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
Arm Title
Best Supportive Care
Arm Type
Active Comparator
Arm Description
treatment mainly on nutrition and symptoms control
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Type
Other
Intervention Name(s)
Best Supportive Care
Primary Outcome Measure Information:
Title
progression free survival and overall survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
Secondary Outcome Measure Information:
Title
response rate
Time Frame
every 4 weeks till progression, total up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathological or cytological confirmed advanced hepatocellular carcinoma
18 years to 80 years
liver function Child-Pugh class B
BCLC stage B or C
estimated life time 2 months or longer
Exclusion Criteria:
previous target therapy
allergy to Sorafenib
Uncontrolled Bleeding or diarrhea
eligible for locoregional treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ketao lan, M.D.
Organizational Affiliation
Qingdao Health Bereau
Official's Role
Study Director
Facility Information:
Facility Name
Qingdao Central Hospital, Qingdao Cancer Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China
12. IPD Sharing Statement
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Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
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