The aim of this research project is to assess the efficacy and toxicity of hypofractionated carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for the treatment of hepatocellular carcinoma
Golden E.B. et al.in 2015 reported that localized radiotherapy granulocyte-macrophage colony-stimulating factor (GM-CSF) produced objective abscopal responses in solid tumor with metastasises. We hypothesize that hypofractionated carbon-ion radiotherapy combining granulocyte-macrophage colony-stimulating factor (GM-CSF) might improve the clinical response rate and progression-free survival (PFS) in hepatocellular carcinoma. The primary endpoint of the current phase II trial is progression-free survival rate at 2 years, secondary endpoints are overall survival, safety and toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
Shanghai Proton and Heavy Ion Center
Shanghai, China
Progression-free survival of all patients
Time in months measured from treatment initiation until the date of progression or the date of last follow-up.
Time frame: 2 year
Overall Survival
Time in months measured from treatment initiation until the date of death or the date of last follow-up.
Time frame: 2 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy]
Objective responses rate
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.