Study of Apatinib After Systemic Therapy in Patients With Hepatocellular Carcinoma(AHELP)

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT02329860
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This was a multicenter, randomized, double-blind, phase III trial. This clinical study evaluates the efficacy and safety of Apatinib in patients with advanced liver cancer who have progressed on Systemic Therapy (Chemotherapy and/or Targeted Therapy). Approximately 400 patients who meet the entry criteria will be randomly assigned in a 2:1 ratio to Apatinib or placebo (1/3 chance to receive placebo). Primary endpoint of the study is overall survival.

Key Dates

Start date
Mar 26, 2014
Status verified
Jul 2017
Primary completion
Dec 15, 2017
Completion
Aug 14, 2019

Study Design

Enrollment
400 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib
    750 mg orally (p.o.) every day (qd), 28 days as one cycle
  • Placebo Comparator: Placebo
    orally (p.o.) every day (qd), 28 days as one cycle

Primary Outcome Measure

Overall Survival [ Time Frame: Approximately 36 months ]

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