Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.
The primary endpoint is local progression free survival. The trial is a single arm phase II trial with the historical arm. The expected 3-year local progression free survival for patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80% and a type I error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients will be enrolled. ;
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