Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy

Prospective Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy

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.

Inclusion Criteria:

1. Participants must have diagnosis of HCC. Participants may have multiple lesions. Diagnosis should be confirmed by at least 1 criteria listed below:

   • Histologically or cytologically proven diagnosis of HCC.
   • Typical arterial enhancement and delayed washout on multiphasic CT or MRI.

2. Age ≥18 years at the time of signing informed consent document.

3. ECOG performance status 0-2.

4. Child-Pugh score 5-9 liver function within 28 days of study registration.

5. Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.

6. Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.

7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Presence of distant metastases that cannot be encompassed by radiotherapy
2. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
3. Inability to treat all sites of disease by radiotherapy
4. Known HIV infection.