Randomized, Double-Blind, Placebo-Controlled, Multicenter Expanding Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma (HCC) (After HCC Resection)
Overview
- Phase
- Phase 3
- Intervention
- Gan Fu Le Tablets
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.
- Enrollment
- 352
- Primary Endpoint
- OS （Overall Survival）
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
the Tyroserleutide for injection
the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid
Intervention: Gan Fu Le Tablets
the Tyroserleutide for injection
the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid
Intervention: Tyroserleutide for injection
the placebo group
the placebo Gan Fu Le Tablets，6 tablets,po,tid
Intervention: Gan Fu Le Tablets
the placebo group
the placebo Gan Fu Le Tablets，6 tablets,po,tid
Intervention: Placebo
Outcomes
Primary Outcomes
OS （Overall Survival）
Time Frame: 3 years
The time from randomization to death due to any reason
Secondary Outcomes
- RFS(Recurrence Free Survival)(3 years)