Expanding Phase III Study of Tyroserleutide for Injection

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)

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

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Gan Fu Le Tablets; Drug: Tyroserleutide for injection; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 352
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the Tyroserleutide for injection; the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid	Drug: Gan Fu Le Tablets; 6 Tablets，tid,po; Drug: Tyroserleutide for injection; 6mg/d, 5days,ivgtt
Placebo Comparator: the placebo group; the placebo Gan Fu Le Tablets，6 tablets,po,tid	Drug: Gan Fu Le Tablets; 6 Tablets，tid,po; Drug: Placebo; 0mg/d, 5days,ivgtt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS （Overall Survival）	The time from randomization to death due to any reason	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RFS(Recurrence Free Survival)	The time from randomization to recurrence, metastasis or death due to any reason	3 years

Collaborators and Investigators

• Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2016
• Primary Completion (Actual): June 13, 2016
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: TYS-CN-1.1PUMP III(C)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No