The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma
The purpose of this study is to determine the maximal tolerated dose (MTD) of carbon ion radiotherapy (CIRT) in the treatment of localized Chinese hepatocellular carcinoma with respective to toxicity and tumor control. Participants will be treated with CIRT with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 3 months after the completion of CIRT. Primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Time interval from the start of CIRT to 3 months after the completion of CIRT
Overall survival of all patients
Overall survival of all patients
Time frame: From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Progression-free survival of all patients
Progression-free survival of all patients
Time frame: From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Number of participants with tumor response as assessed by RECIST 1.1
Number of participants with tumor response as assessed by RECIST 1.1
Time frame: Time interval from the start of CIRT to 3 months after the completion of CIRT
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