Study of tyroserleutide for injection in hepatocellular carcinoma (HCC) patients (clinicaltrials.gov) - Dec 13, 2011 - P3, N=300; Recruiting -> Enrolling by invitation
Recruiting status • Hepatocellular Cancer
|
|
This study is enrolling participants by invitation only.
First Received on December 1, 2011. Last Updated on December 13, 2011 History of Changes
Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Collaborators: Fudan University
Medpace, Inc.
Information provided by (Responsible Party): Shenzhen Kangzhe Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01489566
Purpose
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
Condition
Hepatocellular,Carcinoma
Intervention
Drug: Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )
Drug: the placebo ,chemotherapy(mitomycin, and Fluorouracil )
Phase
Phase III
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Resource links provided by NLM:
MedlinePlus related topics: Cancer
Drug Information available for: Mitomycin Fluorouracil Mitomycins
U.S. FDA Resources
Further study details as provided by Shenzhen Kangzhe Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
RFS(Recurrence Free Survival) [ Time Frame: 0-2years ] [ Designated as safety issue: No ]
The time from randomization to recurrence, metastasis or death due to any reason
Secondary Outcome Measures:
OS （Overall Survival） [ Time Frame: 0-2years ] [ Designated as safety issue: No ]
The time from randomization to death due to any reason
QOL score [ Time Frame: 0-2years ] [ Designated as safety issue: No ]
Quality of life score
Estimated Enrollment: 300
Study Start Date: July 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
|