Hepatocellular Carcinoma Clinical Trial
Official title:
Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial
Study Objective: To evaluate the efficacy and safety of Xihuang Capsules prevention of
recurrence in patients with hepatocellular carcinoma after hepatectomy.
Study Design: The study was A Multicenter, Randomized, Controlled, Open-Label,
Parallel-Group Clinical Trial. Patients will be randomly assigned to Xihuang Capsules group
or the control group by the proportion of 2: 1.
The total sample size: 1000 cases. Study Process: The study is divided into three phases:
the screening phase, treatment phase, follow-up phase.To complete screening in two weeks,
patients who fit the criteria were randomly assigned to Xihuang Capsules group or the
control group.In two weeks after hepatectomy, Xihuang Capsules group received Xihuang
Capsules (2g,bid), Continuously taking to cancer recurrence or death.Control group was not
received Xihuang Capsules. In the first month to three years after treatment, Conducting
visits for once every three months,to evaluate the efficacy and safety with hepatocellular
carcinoma recurrence rate in the three years after hepatectomy as the primary outcome. When
entering the follow-up phase, Keeping in touch with patients withdrew from the study for a
clinic or telephone follow-up every three months.
From signing informed consent till the end of the study, inspecting the adverse events and
concomitant medications for all subjects in each visit.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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