Expanding Phase III Study of Tyroserleutide for Injection

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.

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;