Status:
COMPLETED
Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Collaborating Sponsors:
Tigermed Consulting Co., Ltd
Conditions:
HCC
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients wiht advanced hep...
Detailed Description
Eligibility Criteria: * 18 -70 years old; * Patients with measurable, histologically proven, inoperable HCC; * Child-Pugh (CP) score of A; * Eastern Cooperative Oncology Group (ECOG) performance stat...
Eligibility Criteria
Inclusion
- 18 -70 years old
- Patients with measurable, histologically proven, inoperable HCC
- Child-Pugh (CP) score of A
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- Patients received prior systemic treatments for HCC before 4 weeks
- Patients received operate before 3 months
- Patients received TACE before 4 weeks
- Life expectancy at least 3 months
- Adequate hepatic and renal function
- Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter)
- Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s.
Exclusion
- Patients had prior treatment with sorafenib
- CNS involvement.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02229071
Start Date
April 1 2014
End Date
October 30 2016
Last Update
March 22 2019
Active Locations (1)
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1
West China Hospital,SCU
Chengdu, Sichuan, China, 610041