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

Sponsor

Qidong Gaitianli Medicines Co., Ltd (Industry)

Overall Status

Terminated

CT.gov ID

NCT01760616

Collaborator

Huazhong University of Science and Technology (Other)

790

Enrollment

Location

Arms

67.7

Actual Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Carcinoma	Drug: Huaier Granule	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

790 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

Actual Study Start Date :

Nov 7, 2011

Actual Primary Completion Date :

Aug 15, 2015

Actual Study Completion Date :

Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Huaier Granule Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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

Drug: Huaier Granule

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

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Time to significant progression after surgery and postoperative survival period. [3 years]
Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.

Secondary Outcome Measures

ECOG and QLQ-C30 scores [Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144]
On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, assess the scores of Eastern Cooperative Oncology Group(ECOG) and quality of life questionnaire(QLQ)-C30 scale.
Iconography assessment [Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144]
On week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, give examination of B ultrasonic for Liver, X-ray for chest. If there is a suspected recurrence or metastases, will give enhancement CT/MRI examination for liver and chest; if no recurrence or metastases, will at least give enhancement CT/MRI examination for liver and chest every year.
Alpha-fetoprotein quantitation and related biochemical indicators [Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144]
On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: ≥ 18 and ≤ 75 years, both male and female;
Non-radical hepatectomy has been performed for hepatocellular carcinoma;
The hepatocellular carcinoma has been confirmed by pathological examination;
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;
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;
The expected survival time ≥12 weeks;
The subjects volunteer to sign the informed consent.

Exclusion Criteria:

Non-hepatocellular carcinoma patients;
Those who received radical hepatectomy;
Those with hepatic decompensation;
Pregnant or lactating women;
Those with HIV infection or AIDS-associated diseases;
Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;
Those who can not take drugs by oral route; or those develop serious adverse drug reaction;
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.