Back to resultsExpanding Phase III Study of Tyroserleutide for Injection
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gan Fu Le Tablets
Tyroserleutide for injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
the Tyroserleutide for injection
the placebo group
Arm Description
the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid
the placebo Gan Fu Le Tablets，6 tablets,po,tid
Outcomes
Primary Outcome Measures
OS （Overall Survival）
The time from randomization to death due to any reason
Secondary Outcome Measures
RFS(Recurrence Free Survival)
The time from randomization to recurrence, metastasis or death due to any reason
Full Information
NCT ID
NCT03516448
First Posted
July 4, 2017
Last Updated
May 3, 2018
Sponsor
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03516448
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 24, 2016 (Actual)
Primary Completion Date
June 13, 2016 (Actual)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
352 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the Tyroserleutide for injection
Arm Type
Active Comparator
Arm Description
the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid
Arm Title
the placebo group
Arm Type
Placebo Comparator
Arm Description
the placebo Gan Fu Le Tablets，6 tablets,po,tid
Intervention Type
Drug
Intervention Name(s)
Gan Fu Le Tablets
Intervention Description
6 Tablets，tid,po
Intervention Type
Drug
Intervention Name(s)
Tyroserleutide for injection
Intervention Description
6mg/d, 5days,ivgtt
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0mg/d, 5days,ivgtt
Primary Outcome Measure Information:
Title
OS （Overall Survival）
Description
The time from randomization to death due to any reason
Time Frame
3 years
Secondary Outcome Measure Information:
Title
RFS(Recurrence Free Survival)
Description
The time from randomization to recurrence, metastasis or death due to any reason
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
12. IPD Sharing Statement
Learn more about this trial
Expanding Phase III Study of Tyroserleutide for Injection
We'll reach out to this number within 24 hrs