Study of Tyroserleutide for Injection in Hepatocellular Carcinoma (HCC) Patients

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions one month 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.

The objective is to evaluate the effect of Injectable Tyroserleutide on the recurrence-free survival,overall survival,quality of life,and the safety and tolerability of subjects after the resection of hepatocellular carcinoma

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

Details

• Lead Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
• Collaborators: Fudan University; Medpace, Inc.
• Treatments: Fluorouracil; Mitomycin; Mitomycins

Criteria

Perioperative Period Inclusion Criteria

1. Signed informed consent;

2. Aged ≥ 18 years and ≤ 75 years old, male or female；

3. Subject underwent a complete resection of hepatocellular carcinoma (confirmed by pathology);

4. The tumor characteristics must meet one of the following:

• Tumor thrombosis in the portal vein branches is detected by either;

• Preoperative imaging, or;

• Intraoperative visual observation.

• Tumor thrombosis in the portal vein branches was not detected; and

• A single tumor with a maximum diameter ≥8cm confirmed by preoperative imaging, and histological evidence of micro vascular tumor thrombosis; or

• Preoperative imaging confirmed that there are 2 or more tumor lesions

Perioperative Period Exclusion Criteria

1. Concomitant malignant primary tumor(s) in other systems is/are present;

2. Tumor thrombosis in the main branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery;

3. 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;

4. The subject took other study/investigational drugs 7 days prior to the resection surgery;

5. The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;

6. The subject has history of study drug or similar drug allergy

Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria

1. Baseline (post-resection) liver CT (normal CT + contrast enhanced CT) and chest CT scan show no tumor lesions;

2. Child-Pugh score of class A at baseline

Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria

1. Body surface area is < 1.47 m2 or > 1.92 m2;

2. Concomitant malignant primary tumor(s) in other systems is/are present;

3. The subject took other study/investigational drugs within 4 weeks prior to randomization;

4. The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;

5. The baseline examination suggests the presence of tumor metastasis;

6. The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;

7. The subject has history of investigational drug or similar drug allergy;

8. The subject is pregnant, lactating, or urine pregnancy test result is positive