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

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Zai Lab

Status and phase

Completed
Phase 2

Conditions

Hepatocellular Carcinoma (HCC)

Treatments

Drug: Brivanib 800 mg, QD
Drug: Brivanib 400 mg, BID

Study type

Interventional

Funder types

Industry

Identifiers

NCT03516071
ZL-2301-001

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Brivanib 800 mg, QD + BSC
Experimental group
Treatment:
Drug: Brivanib 800 mg, QD
Brivanib 400 mg, BID + BSC
Experimental group
Treatment:
Drug: Brivanib 400 mg, BID

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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