Hepatic Carcinoma
Conditions
Keywords
Huaier Granule;, After non-radical hepatectomy;, Prevention of Disease Progression of Hepatocarcinoma;, Safety.
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.
Interventions
DRUGHuaier Granule
Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..
Sponsors
Huazhong University of Science and Technology
Qidong Gaitianli Medicines Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed