To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
790
Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..
Tongji Hospital Affiliated to Tongji Medical College, Huazhong
Wuhan, Hubei, China
Time to significant progression after surgery and postoperative survival period.
Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.
Time frame: 3 years
ECOG and QLQ-C30 scores
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.
Time frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Iconography assessment
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.
Time frame: Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Alpha-fetoprotein quantitation and related biochemical indicators
On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation.
Time frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
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