Expanding Phase III Study of Tyroserleutide for Injection

Shenzhen Kangzhe Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Placebo; Drug: Gan Fu Le Tablets; Drug: Tyroserleutide for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03516448

TYS-CN-1.1PUMP III(C)

Details and patient eligibility

About

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

Full 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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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352 participants in 2 patient groups, including a placebo group

the Tyroserleutide for injection

Active Comparator group

Description:

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

Treatment:

Drug: Tyroserleutide for injection

Drug: Gan Fu Le Tablets

the placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Gan Fu Le Tablets