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

Phase 3

• Conditions: Hepatocellular,Carcinoma
• Interventions: Drug: Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil ); Drug: the placebo ,chemotherapy(mitomycin, and Fluorouracil )

• Registration Number: NCT01489566
• Lead Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2011-07
• Status Verified: 2011-12
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-09
• Last Update Submitted: 2011-12-13
• Last Update Posted: 2011-12-14
• Primary Completion: 2013-03
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tyroserleutide for injection	Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )	the Tyroserleutide for injection at the dosage of 6mg/d
the placebo	the placebo ,chemotherapy(mitomycin, and Fluorouracil )	-

Primary Outcome Measures

Name	Time	Method
RFS(Recurrence Free Survival)	0-2years	The time from randomization to recurrence, metastasis or death due to any reason

Secondary Outcome Measures

Name	Time	Method
OS （Overall Survival）	0-2years	The time from randomization to death due to any reason
QOL score	0-2years	Quality of life score

Trial Locations

Locations (1)

Fudan University Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China