NCT03516448

Expanding Phase III Study of Tyroserleutide for Injection

Randomized, Double-Blind, Placebo-Controlled, Multicenter Expanding Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma (HCC) (After HCC Resection)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (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 21 days 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

Detailed description

* The first stage includes evaluation of subjects, to assess the inclusion criteria and exclusion criteria, based on the patients' preoperative imaging results, including tumor size, tumor characteristics, etc. * In the second stage, subjects will return to the hospital 21 days following the baseline examination.The investigator will determine whether the subject satisfies all inclusion/exclusion criteria. If all requirements are satisfied, then randomization will occur 21 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). and the relevant laboratory tests will be performed within 3 days after the end the study drug infusion. * Cycles will occur as follows: cycles 2, 3, 4, 5, and n will begin on days 42±3, 70±3, 98±3, 126±3, and 14+28（n-1)± 3, respectively. * Based therapeutic drugs are Gan Fu Le * the participant will receive medical inspection so as to observe and ensure drug safety.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Gan Fu Le Tablets	6 Tablets，tid,po
DRUG	Tyroserleutide for injection	6mg/d, 5days,ivgtt
DRUG	Placebo	0mg/d, 5days,ivgtt

Timeline

• Start date: 2016-03-24
• Primary completion: 2016-06-13
• Completion: 2019-06-01
• First posted: 2018-05-04
• Last updated: 2018-05-04