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

Qidong Gaitianli Medicines

Status and phase: Completed; Phase 4

Conditions: Hepatic Carcinoma

Treatments: Drug: Huaier Granule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01770431

HE-201101

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,044 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,044 participants in 2 patient groups

Huaier Granule group

Experimental group

Description:

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.

Treatment:

Drug: Huaier Granule

Bank-control group

No Intervention group

Description:

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.