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.
Study Type
OBSERVATIONAL
Enrollment
300
* 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
Chang Gung Memorial Hospital at Linkou
Taoyuan, Taiwan, Taiwan
RECRUITINGProgression 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.
Time frame: 12 months
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 frame: 12 months
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.
Time frame: 12 months
Overall Response Rate (ORR)
ORR is defined as a complete or partial response according to RECIST1.1.
Time frame: 12 months
Overall survival (OS)
OS is defined as the time from signing the informed consent to death from any cause.
Time frame: 12 months
Incidence and severity of adverse events
Adverse events will be graded using CTCAE v5
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.