Expanding Phase III Study of Tyroserleutide for Injection

Last updated: May 3, 2018
Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Overall Status: Trial Status Unknown

Phase

3

Condition

Carcinoma

Cancer/tumors

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT03516448
TYS-CN-1.1PUMP III(C)
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 maximumdiameter >5cm ,Preoperative imaging, or Intraoperative visual observation.;

Exclusion

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 bypreoperative imaging or observed during the surgery

  • The subject received any previous systemic anti-HCC therapy prior to the resectionsurgery (except the resection surgery), such as liver transplantation, intervention,ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCCtherapy

  • 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 daysprior 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 otherpostoperative complications are present

  • The subject is pregnant, lactating, or urine pregnancy test result is positive

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

Study Design

Total Participants: 352
Study Start date:
March 24, 2016
Estimated Completion Date:
June 30, 2019

Study 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.