NCT01489566

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular,Carcinoma

Interventions

Type	Name	Description
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
DRUG	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

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-03-01
• Completion: 2013-08-01
• First posted: 2011-12-09
• Last updated: 2011-12-14

Locations

1 site across 1 country: China