Expanding Phase III Study of Tyroserleutide for Injection

NCT ID: NCT03516448

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-24
• Study Completion Date: 2019-06-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the Tyroserleutide for injection

the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid

Group Type: ACTIVE_COMPARATOR

Gan Fu Le Tablets

Intervention Type: DRUG

6 Tablets，tid,po

Tyroserleutide for injection

Intervention Type: DRUG

6mg/d, 5days,ivgtt

the placebo group

the placebo Gan Fu Le Tablets，6 tablets,po,tid

Group Type: PLACEBO_COMPARATOR

Gan Fu Le Tablets

Intervention Type: DRUG

6 Tablets，tid,po

Placebo

Intervention Type: DRUG

0mg/d, 5days,ivgtt

Interventions

Gan Fu Le Tablets

6 Tablets，tid,po

Intervention Type: DRUG

Tyroserleutide for injection

6mg/d, 5days,ivgtt

Intervention Type: DRUG

Placebo

0mg/d, 5days,ivgtt

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TYS-CN-1.1PUMP III(C)

Identifier Type: -

Identifier Source: org_study_id