Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

Phase 4 Completed 1044 enrolled Qidong Gaitianli Medicines Co., Ltd Huazhong University of Science and Technology · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.

Timeline

Start: 2011-08
Primary completion: 2016-08
Completion: 2016-08

Outcome

Met primary endpoint

registry analysis (superiority test); Huaier Granule Group vs Bank-control Group; p = 0.0001; chi-squared 14.7315; Cochran-Mantel-Haenszel NCT01770431 ↗

paper The difference in the RFS rate between Huaier and control groups was 62.39% and 49.05% (95% CI 6.74 to 19.94; p=0.0001); PMID 29802174 ↗

Publications

Chen Q, Shu C, Laurence AD, Chen Y, Peng BG, Zhen ZJ, Cai JQ, Ding YT, Li LQ, Zhang YB, Zheng QC, Xu GL, Li B, Zhou WP, Cai SW, Wang XY, Wen H, Peng XY, Zhang XW, Dai CL, Bie P, Xing BC, Fu ZR, Liu LX, Mu Y, Zhang L, Zhang QS, Jiang B, Qian HX, Wang YJ, Liu JF, Qin XH, Li Q, Yin P, Zhang ZW, Chen XP. Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial. Gut. 2018 Nov;67(11):2006-2016. doi: 10.1136/gutjnl-2018-315983. Epub 2018 May 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Huaier Granule	Traditional medicine (herbal / TCM)	20 g	Oral