Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
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.