Overview

This trial is active, not recruiting.

Condition hepatic carcinoma
Treatment huaier granule
Phase phase 4
Sponsor Qidong Gaitianli Medicines Co., Ltd
Collaborator Huazhong University of Science and Technology
Start date August 2011
End date December 2016
Trial size 1080 participants
Trial identifier NCT01770431, HE-201101

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
huaier granule Huaier
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
(Placebo Comparator)
Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents. During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.
huaier granule Huaier
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.

Primary Outcomes

Measure
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 6 after took medicine
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 14 after took medicine
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 22 after took medicine
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 34 after took medicine
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 46 after took medicine
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 58 after took medicine
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 70 after took medicine
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 82 after took medicine
Incidence and occurrence time of recurrence and metastasis after hepatectomy
time frame: Week 94 after took medicine

Secondary Outcomes

Measure
Postoperative survival period
time frame: Week 6,14,22,34,46,58,70,82,94 after took medicine

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Principal investigator Xiaoping Chen, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Qidong Gaitianli Medicines Co., Ltd.