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

NCT ID: NCT01760616

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 790 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-07
• Study Completion Date: 2017-06-30

Brief Summary

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

Detailed 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.

Conditions

Hepatic Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Test group

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

Group Type: EXPERIMENTAL

Huaier Granule

Intervention Type: DRUG

Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..

Control group: adjuvant therapy

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Huaier Granule

Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Qidong Gaitianli Medicines Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoping Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology

Locations

Tongji Hospital Affiliated to Tongji Medical College, Huazhong

Wuhan, Hubei, China

Countries

China

Other Identifiers

HE-201102

Identifier Type: -

Identifier Source: org_study_id