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
Results First Posted : January 22, 2024
Last Update Posted : January 22, 2024
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Tracking Information | |||
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First Submitted Date ICMJE | December 30, 2014 | ||
First Posted Date ICMJE | January 1, 2015 | ||
Results First Submitted Date ICMJE | April 26, 2023 | ||
Results First Posted Date ICMJE | January 22, 2024 | ||
Last Update Posted Date | January 22, 2024 | ||
Actual Study Start Date ICMJE | March 26, 2014 | ||
Actual Primary Completion Date | December 15, 2017 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: Approximately 36 months ] | ||
Original Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: Approximately 30 months ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study of Apatinib After Systemic Therapy in Patients With Hepatocellular Carcinoma(AHELP) | ||
Official Title ICMJE | 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) | ||
Brief 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. |
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Carcinoma, Hepatocellular | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Qin S, Li Q, Gu S, Chen X, Lin L, Wang Z, Xu A, Chen X, Zhou C, Ren Z, Yang L, Xu L, Bai Y, Chen L, Li J, Pan H, Cao B, Fang W, Wu W, Wang G, Cheng Y, Yu Z, Zhu X, Jiang D, Lu Y, Wang H, Xu J, Bai L, Liu Y, Lin H, Wu C, Zhang Y, Yan P, Jin C, Zou J. Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Jul;6(7):559-568. doi: 10.1016/S2468-1253(21)00109-6. Epub 2021 May 8. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
400 | ||
Original Estimated Enrollment ICMJE |
360 | ||
Actual Study Completion Date ICMJE | August 14, 2019 | ||
Actual Primary Completion Date | December 15, 2017 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | China | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02329860 | ||
Other Study ID Numbers ICMJE | APTN-III-HCC | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Jiangsu HengRui Medicine Co., Ltd. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | NanJing PLA 81 Hospital | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Jiangsu HengRui Medicine Co., Ltd. | ||
Verification Date | July 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |