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Clinical Trials/NCT01489566
NCT01489566
Unknown
Phase 3

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

Shenzhen Kangzhe Pharmaceutical Co., Ltd.1 site in 1 country300 target enrollmentJuly 2011

Overview

Phase
Phase 3
Intervention
Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )
Conditions
Hepatocellular,Carcinoma
Sponsor
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Enrollment
300
Locations
1
Primary Endpoint
RFS(Recurrence Free Survival)
Last Updated
14 years ago

Overview

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 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

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 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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
August 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Tyroserleutide for injection

the Tyroserleutide for injection at the dosage of 6mg/d

Intervention: Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )

the placebo

Intervention: the placebo ,chemotherapy(mitomycin, and Fluorouracil )

Outcomes

Primary Outcomes

RFS(Recurrence Free Survival)

Time Frame: 0-2years

The time from randomization to recurrence, metastasis or death due to any reason

Secondary Outcomes

  • OS (Overall Survival)(0-2years)
  • QOL score(0-2years)

Study Sites (1)

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