Status:
UNKNOWN
Study of Tyroserleutide for Injection in Hepatocellular Carcinoma (HCC) Patients
Lead Sponsor:
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Fudan University
Medpace, Inc.
Conditions:
Hepatocellular,Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
* Subjects will return to the hospital 25±5 days after the resection of hepatocellular carcinoma following the baseline examination. Baseline imaging data will be sent to the lead study site imaging c...
Eligibility Criteria
Inclusion
- Perioperative Period Inclusion Criteria
- Signed informed consent;
- Aged ≥ 18 years and ≤ 75 years old, male or female；
- Subject underwent a complete resection of hepatocellular carcinoma (confirmed by pathology);
- 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
- Concomitant malignant primary tumor(s) in other systems is/are present;
- Tumor thrombosis in the main 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 other study/investigational drugs 7 days prior to the resection surgery;
- 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 study drug or similar drug allergy
- Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria
- Baseline (post-resection) liver CT (normal CT + contrast enhanced CT) and chest CT scan show no tumor lesions;
- Child-Pugh score of class A at baseline
- Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria
- Body surface area is \< 1.47 m2 or \> 1.92 m2;
- Concomitant malignant primary tumor(s) in other systems is/are present;
- The subject took other study/investigational drugs within 4 weeks prior to randomization;
- The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
- The baseline examination suggests the presence of tumor metastasis;
- 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 subject is pregnant, lactating, or urine pregnancy test result is positive
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01489566
Start Date
July 1 2011
End Date
August 1 2013
Last Update
December 14 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032