Expanding Phase III Study of Tyroserleutide for Injection

Hepatocellular Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03516448
• Other study ID #: TYS-CN-1.1PUMP III(C)
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: March 24, 2016
• Est. completion date: June 2019

Study information

• Verified date: April 2018
• Source: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 352
• Est. completion date: June 2019
• Est. primary completion date: June 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Gan Fu Le Tablets
6 Tablets,tid,po
• Tyroserleutide for injection
6mg/d, 5days,ivgtt
• Placebo
0mg/d, 5days,ivgtt

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS (Overall Survival)	The time from randomization to death due to any reason	3 years
Secondary	RFS(Recurrence Free Survival)	The time from randomization to recurrence, metastasis or death due to any reason	3 years