At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 400 enrolled
Drug / intervention
Apatinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study (AHELP) of Apatinib in Patients With Hepatocellular Carcinoma After Systemic Therapy（Chemotherapy and/or Targeted Therapy）
In Brief
A Phase 3 clinical trial evaluating Apatinib and Placebo for Carcinoma, Hepatocellular. Completed, enrolled 400 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesChina
CollaboratorsNanJing PLA 81 Hospital
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedJan 2015
Primary CompletionDec 2017
Study CompletionAug 2019
TodayJul 2026
First PostedJan 1, 2015
Enrollment StartMar 26, 2014
Primary CompletionDec 15, 2017
Study CompletionAug 14, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.5 years ago
Interventions
Apatinibdrug
Placebodrug