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
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.
Investigators
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)