Radiation therapy is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma. Our previous preclinical investigation revealed that radiotherapy can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor T cell responses in murine tumor models. However, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving hepatocellular carcinoma patients. Given that radiotherapy represents a standard therapeutic approach for unresectable hepatocellular carcinoma, our ongoing phase II non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive radiotherapy for hepatocellular carcinoma.
Histologically or cytologically proven diagnosis of HCC.
Typical arterial enhancement and delayed washout on multiphasic CT or MRI.
Age ≥18 years at the time of signing informed consent document.
ECOG performance status 0-2.
Presence of distant metastases that cannot be encompassed by radiotherapy
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Inability to treat all sites of disease by radiotherapy
Known HIV infection.
Patients undergoing routine radiotherapy using photons or protons for HCC
Cohort
Prospective
Photon or proton radiotherapy
Radiation* 39.6-72.6 Gy (or Cobalt Gray Equivalent, CGE) in 22 fractions for tumors ≤1 cm from hepatic hilum, bowel, and heart. * 30-66 Gy (or CGE) in 10 fractions for tumors \>1 cm from hepatic hilum, bowel, and heart. * 27.5-60 Gy (or CGE) in 5 fractions using stereotactic body radiation therapy (SBRT) techniques
Progression free survival (PFS)
PFS is defined as the time from signing the informed consent to the first occurrence of disease progression or death from any cause (whichever occurs first) according to RECIST1.1.
Local control (LC)
LC is defined as the time from signing the informed consent to the first occurrence of disease progression in the irradiated field according to RECIST1.1.
Time to progression (TTP)
TTP is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1.
Overall Response Rate (ORR)
ORR is defined as a complete or partial response according to RECIST1.1.
Overall survival (OS)
OS is defined as the time from signing the informed consent to death from any cause.
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