Hepatocellular,Carcinoma Clinical Trial
Official title:
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
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
- 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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment