Hepatocellular Carcinoma
Conditions
Brief summary
This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions 21 days after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection), or placebo
Detailed description
* The first stage includes evaluation of subjects, to assess the inclusion criteria and exclusion criteria, based on the patients' preoperative imaging results, including tumor size, tumor characteristics, etc. * In the second stage, subjects will return to the hospital 21 days following the baseline examination.The investigator will determine whether the subject satisfies all inclusion/exclusion criteria. If all requirements are satisfied, then randomization will occur 21 days after surgery * The day of randomization will be defined as Day 0. Randomized subjects will return to the hospital and begin cycle 1 on the day of randomization (Day 0). and the relevant laboratory tests will be performed within 3 days after the end the study drug infusion. * Cycles will occur as follows: cycles 2, 3, 4, 5, and n will begin on days 42±3, 70±3, 98±3, 126±3, and 14+28（n-1)± 3, respectively. * Based therapeutic drugs are Gan Fu Le * the participant will receive medical inspection so as to observe and ensure drug safety.
Interventions
DRUGGan Fu Le Tablets
6 Tablets，tid,po
DRUGTyroserleutide for injection
6mg/d, 5days,ivgtt
DRUGPlacebo
0mg/d, 5days,ivgtt
Sponsors
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Aged ≥ 18 years and ≤ 75 years old, male or female * Subject underwent resection of hepatocellular carcinoma (confirmed by pathology) * The tumor characteristics must meet the following:A single tumor with a maximum diameter \>5cm ,Preoperative imaging, or Intraoperative visual observation.;
Exclusion criteria
* Concomitant malignant tumor(s) in other systems is/are present * Tumor thrombosis in the branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery * The subject received any previous systemic anti-HCC therapy prior to the resection surgery (except the resection surgery), such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC therapy * The subject took Sorafenib prior to randomization * The subject took other study/investigational drugs 7 days prior to randomization * The subject took Kang Laike injection/soft capsule，or Jinke Huaier granule 7 days prior to randomization * The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases * The subject has history of investigational drug or similar drug allergy * The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present * The subject is pregnant, lactating, or urine pregnancy test result is positive * Baseline (post-resection) examination exist tumor recurrence or metastasis;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS （Overall Survival） | 3 years | The time from randomization to death due to any reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFS(Recurrence Free Survival) | 3 years | The time from randomization to recurrence, metastasis or death due to any reason |
Outcome results
None listed