Donafenib versus sorafenib for advanced hepatocellular cancer.
This phase 3 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients wiht advanced hepatocellular carcinoma (HCC).The study is a randomised,controlled,multicentre study.The controlled drug is sorafenib(Nexavar).The primary endpoint is overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
668
The PLA 81 Hospital
Nanjing, Jiangsu, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Overall Survival
Patient visits are scheduled every 8 weeks to monitor efficacy.
Time frame: 3 years
Progress Free Survival
Patient visits are scheduled every 8 weeks to monitor efficacy.Progressive disease is measured from the date of randomization until dead or disease progression according to Response Evaluation Criteria in Solid Tumors(Version 1.1)
Time frame: 2 years
Percentage of adverse events
Patient visits are scheduled every 4 weeks to monitor safety and drug accountability. Patients were monitored for adverse events by use of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version 4.0
Time frame: 3 years
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