A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC

A Multicenter, Randomized, Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Brivanib Alaninate (ZL-2301) Combined With Best Supportive Care (BSC) and Pharmacokinetic Profiles of Brivanib Alaninate in Patients With Advanced Hepatocellular Carcinoma (HCC) Failed or Intolerant of Standard Systemic Chemotherapy and/or Sorafenib

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03516071

Enrollment

Registered

2018-05-04

Start date

2017-05-17

Completion date

2019-07-19

Last updated

2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Hepatocellular Carcinoma, HCC, Brivanib

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.

Interventions

DRUGBrivanib 800 mg, QD

Brivanib Alaninate 800 mg QD, PO

DRUGBrivanib 400 mg, BID

Brivanib Alaninate 400 mg BID, PO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026