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

Hepatocellular,Carcinoma Clinical Trial

Official title:

A Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01489566
• Other study ID #: TYS-CN-1.1PUMP III
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: December 1, 2011
• Last updated: December 13, 2011
• Start date: July 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2011
• Source: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 center for review and verification. The investigator will determine whether the subject satisfies all inclusion/exclusion criteria. If all requirements are satisfied, then randomization will occur 25±5 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). The Investigator will administer chemotherapy according to the subject's condition. On the next day, experimental drug therapy will begin, and the relevant laboratory tests will be performed within 3 days after the end the study drug infusion.

• Cycles will occur every four weeks for the first 6 cycles (i.e. cycles 2, 3, 4, 5, and 6 will begin on days 28 ± 3, 56 ± 3, 84 ± 3, 112 ± 3, and 140 ± 3, respectively). The second 6 cycles will occur every eight weeks (i.e. cycles 7, 8, 9, 10, and 11, will begin on days 196 ± 3, 252 ± 3, 308 ± 3, 364 ± 3, and 420 ± 3, respectively).

• the participant will receive medical inspection so as to observe and ensure drug safety.

• A CT scan will be performed for each participant to exclude the recurrence or metastasis of tumor and assess the effects of treatment once before the initiation of each new cycle.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular,Carcinoma

Intervention

Drug:
• Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )
mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; Tyroserleutide for injection(30mg) ,through the micro infusion pump,every cycle,3-5 days
• the placebo ,chemotherapy(mitomycin, and Fluorouracil )
mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; the placebo(30mg) ,through the micro infusion pump,every cycle,3-5 days

Locations

Country	Name	City	State
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shenzhen Kangzhe Pharmaceutical Co., Ltd.	Fudan University, Medpace, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFS(Recurrence Free Survival)	The time from randomization to recurrence, metastasis or death due to any reason	0-2years	No
Secondary	OS (Overall Survival)	The time from randomization to death due to any reason	0-2years	No
Secondary	QOL score	Quality of life score	0-2years	No