Clinical trial NCT01760616: Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatic Carcinoma
Keywords: Huaier Granule;
After non-radical hepatectomy;
Prevention of Disease Progression of Hepatocarcinoma;
Safety.
Lead sponsor: Qidong Gaitianli Medicines Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Huazhong University of Science and Technology
First posted: 2013-01-04
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Time to significant progression after surgery and postoperative survival period.
timeFrame: 3 years
Secondary outcomes:
measure: ECOG and QLQ-C30 scores
timeFrame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
measure: Iconography assessment
timeFrame: Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
measure: Alpha-fetoprotein quantitation and related biochemical indicators
timeFrame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College, Huazhong
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Xiaoping Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: