A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- Registration Number
- NCT03516071
- Lead Sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Brief Summary
This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 18-75 years, male or female
- Histologically or cytologically confirmed or the clinical diagnosis standard confirmed hepatocellular carcinoma (HCC) patients
- Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy
- Liver function status Child-Pugh Class A or B (score≤7)
- ECOG Performance Status score 0 or 1
- Patients must have adequate bone marrow, renal and hepatic function
- Known history or symptomatic metastatic brain
- Uncontrolled moderate and severe ascites
- With bleeding tendency and thrombosis history
- Known history of severe cardiovascular disease
- Uncontrollable active infections (≥CTCAE Grade 2)
- Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brivanib 800 mg, QD + BSC Brivanib 800 mg, QD - Brivanib 400 mg, BID + BSC Brivanib 400 mg, BID -
- Primary Outcome Measures
Name Time Method Disease control rate (DCR) at 3 months from randomization 12 weeks from randomization Defined as the percentage of patients with complete response, partial response, or stable disease at 12 weeks from randomization by RECIST v1.1.
Time to Progress (TTP) 12 weeks from randomization Defined as the time from random assignment to radiologic disease progression.
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) at 6 months from randomization 24 weeks from randomization Defined as the percentage of patients with complete response, partial response, or stable disease at 24 weeks from randomization by RECIST v1.1.
Progression-free survival (PFS) 24 weeks from randomization Defined as the time from random assignment until the date of disease progression or death as a result of any cause.
Objective response rate (ORR) 24 weeks from randomization Defined as the proportion of randomized patients with CR or PR as the optimal response in each treatment group assessed by use of RECIST 1.1 criteria
Overall survival (OS) 24 weeks from randomization Refers to the duration from randomization to death from any cause
Trial Locations
- Locations (15)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
China PLA 81st hospital
🇨🇳Nanjing, Jiangsu, China
The first Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Army General Hospital of Shenyang military region
🇨🇳Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Scroll for more (5 remaining)Anhui Provincial Hospital🇨🇳Hefei, Anhui, China