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

Phase 3 Completed 400 enrolled Jiangsu HengRui Medicine Co., Ltd. NanJing PLA 81 Hospital · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2014-03-26
Primary completion: 2017-12-15
Completion: 2019-08-14

Outcome

Met primary endpoint

paper Overall survival was significantly improved in the apatinib group compared with the placebo group PMID 33971141 ↗

paper hazard ratio 0·785 [95% CI 0·617‒0·998], p=0·048 PMID 33971141 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rivoceranib	Small molecule	750 mg	Oral