Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

Qidong Gaitianli Medicines

Status and phase: Terminated; Phase 4

Conditions: Hepatic Carcinoma

Treatments: Drug: Huaier Granule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01760616

HE-201102

Details and patient eligibility

About

To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

Full description

A Prospective, Multicenter, Open-labeled, Parallel -controlled Clinical Study, to evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

Enrollment: 790 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: ≥ 18 and ≤ 75 years, both male and female;
2. Non-radical hepatectomy has been performed for hepatocellular carcinoma;
3. The hepatocellular carcinoma has been confirmed by pathological examination;
4. 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 ≤2 ULN, serum creatinine <1.5 ULN;
5. Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, neutrophil count> 1.5×109/L;
6. The expected survival time ≥12 weeks;
7. The subjects volunteer to sign the informed consent.

Exclusion criteria

1. Non-hepatocellular carcinoma patients;
2. Those who received radical hepatectomy;
3. Those with hepatic decompensation;
4. Pregnant or lactating women;
5. Those with HIV infection or AIDS-associated diseases;
6. Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;
7. Those who can not take drugs by oral route; or those develop serious adverse drug reaction;
8. Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
9. Conditions that are considered not suitable for this study investigators.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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790 participants in 2 patient groups

Test group

Experimental group

Description:

Test group: Adjuvant therapy + Huaier Granule group.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 144 weeks after surgery or until study termination Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment

Treatment:

Drug: Huaier Granule

Control group: adjuvant therapy

No Intervention group

Description:

Control group: adjuvant therapy Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment.