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

Hepatic Carcinoma Clinical Trial

Official title:

A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770431
• Other study ID #: HE-201101
• Status: Completed
• Phase: Phase 4
• First received: January 1, 2013
• Last updated: May 5, 2017
• Start date: August 2011
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Qidong Gaitianli Medicines Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1044
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatic Carcinoma
• Neoplasm Metastasis
• Recurrence

Intervention

Drug:
• Huaier Granule
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.

Locations

Country	Name	City	State
China	Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Qidong Gaitianli Medicines Co., Ltd	Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Recurrence and Metastasis After Hepatectomy	At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.	Week 94 after took medicine
Secondary	Postoperative Survival Period	Assess Postoperative survival period	Week 94 after took medicine