Clinical trial NCT01770431: Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Official title: A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatic Carcinoma
Keywords: Huaier Granule;
After radical hepatectomy;
Prevention of Recurrence and Metastasis;
Safety.
Lead sponsor: Qidong Gaitianli Medicines Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Huazhong University of Science and Technology
First posted: 2013-01-17
Enrollment: 1044
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: A Multicenter, Randomized, Paralleled control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma after Radical Hepatectomy,to evaluate the efficacy and safety.

Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18 and ≤ 75 years, both male and female;
* Radical hepatectomy has been performed for hepatocellular carcinoma;
* The hepatocellular carcinoma has been confirmed by pathological examination;
* Barcelona clinic liver cancer(BCLC) stage A or B;
* Not receiving any preoperative anticancer drug;
* The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)\<3 upper limit of normal(ULN), total bilirubin≤2ULN, serum creatinine \<1.5 ULN;
* Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, absolute neutrophil count\>1.0×109/L;
* The expected survival time ≥ 12 weeks;
* The subjects volunteer to sign the informed consent.

Exclusion Criteria:

* Hepatocellular carcinoma patients who received non-radical hepatectomy;
* Non-hepatocellular carcinoma patients;
* Those with Child-Pugh C;
* Pregnant or lactating women;
* Those with active bleeding due to various reasons;
* Those with HIV infection or AIDS-associated diseases;
* Those with severe acute and chronic diseases;
* Those with severe diabetes;
* Those with serious infectious diseases;
* Those who can not take drugs by oral route;
* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
* Conditions that are considered not suitable for this study investigators

Primary outcomes:
measure: Incidence of Recurrence and Metastasis After Hepatectomy
timeFrame: Week 94 after took medicine
Secondary outcomes:
measure: Postoperative Survival Period
timeFrame: Week 94 after took medicine
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Xiaoping Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.