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

Phase 4

Terminated

• Conditions: Hepatic Carcinoma
• Interventions: Drug: Huaier Granule

• Registration Number: NCT01760616
• Lead Sponsor: Qidong Gaitianli Medicines Co., Ltd

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.

Study Timeline

• Study Start: 2011-11-07
• Study First Submitted: 2013-01-01
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Primary Completion: 2015-08-15
• Study Completion: 2017-06-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 790

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Huaier Granule	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong; 🇨🇳 Wuhan, Hubei, China