Clinical trial NCT03516448: Expanding Phase III Study of Tyroserleutide for Injection
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Baseline (post-resection) examination exist tumor recurrence or metastasis;

Primary outcomes:
measure: OS （Overall Survival）
timeFrame: 3 years
Secondary outcomes:
measure: RFS(Recurrence Free Survival)
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: