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

Phase 4

Completed

• Conditions: Hepatic Carcinoma
• Interventions: Drug: Huaier Granule

• Registration Number: NCT01770431
• Lead Sponsor: Qidong Gaitianli Medicines Co., Ltd

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-01-01
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2017-01-02
• Status Verified: 2017-03
• Results First Submitted QC: 2017-05-05
• Last Update Submitted: 2017-05-05
• Results First Posted: 2017-10-02
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1044

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Huaier Granule group	Huaier Granule	Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd.. Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.

Primary Outcome Measures

Name	Time	Method
Incidence of Recurrence and Metastasis After Hepatectomy	Week 94 after took medicine	At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.

Secondary Outcome Measures

Name	Time	Method
Postoperative Survival Period	Week 94 after took medicine	Assess Postoperative survival period

Trial Locations

Locations (1)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China