Study of Apatinib After Systemic Therapy in Patients With Hepatocellular Carcinoma(AHELP)
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|ClinicalTrials.gov Identifier: NCT02329860|
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : February 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: Apatinib Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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）|
|Actual Study Start Date :||January 13, 2014|
|Actual Primary Completion Date :||December 15, 2017|
|Actual Study Completion Date :||February 29, 2020|
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
- Overall Survival [ Time Frame: Approximately 36 months ]
- Time to progression（TTP） [ Time Frame: Approximately 36 months ]
- Progression free survival (PFS) [ Time Frame: Approximately 36 months ]
- Objective tumor response [ Time Frame: Approximately 36 months ]
- Disease control RATE [ Time Frame: Approximately 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329860
|Jiangsu hengrui medicine CO. LTD|
|Lianyungang, Jiangsu, China, 222047|