In the present study, we aim to investigate the efficacy and safety of concurrent therapy of Immunotherapy based combination therapy and Radiotherapy in patients with advanced HCC showing macrovascular invasion.
Signed informed consent form
Age >= 19 at the time of signing Informed consent form
Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association -National Cancer Center
Unresectable and/or locally advanced or metastatic disease showing major vascular invasion
Fibrolamellar carcinoma or sarcomatoid carcinoma
Receipt of 2 or more prior systemic therapy for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.
Receipt of other first-line systemic therapy than immune checkpoint inhibitor-based regimen
Receipt of prior radiation therapy to liver
Factorial
Particle beam radiation therapy
RadiationThe prescribed dose and fractionation for proton therapy to the PTV will be determined by the physician, taking into account the dose-volume constraints of normal tissues such as the liver and bowel.
PFS (Progression-free survival)
PFS is defined as the time from the date of treatment initiation to the date of the first observation of progressive disease (PD) by the investigator according to RECIST v1.1 criteria or death from any cause.
OS(overall survival)
OS is defined as the time from the date of treatment initiation to the date of death from any cause.
TTP(Time to progression)
TTP is defined as the time from the date of treatment initiation to the date of the first observation of PD by the investigator according to RECIST v1.1 criteria.
ORR(Objective response rate)
ORR is defined as the proportion of participants whose best overall response is CR or PR as determined by the investigator according to RECIST v1.1 criteria.
DCR(Disease control rate)
DCR is defined as the proportion of participants whose best overall response is a CR, PR, or SD as determined by the investigator according to RECIST v1.1 criteria.
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