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Studies immune responses in liver cancer patients receiving radiotherapy

Observes immune responses and outcomes in adults with liver cancer treated with radiation.

Plain-language title generated from the registry record
Registry title: Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy

Key facts

Where
Taoyuan City, TaiwanSee the site

Where in Taiwan

  • Chang Gung Memorial Hospital at LinkouTaoyuan City, TaiwanTaking people

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Trial details

Who runs it
Chang Gung Memorial Hospital
Trial code
NCT06379256
Record updated
1 October 2026
Original description
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.Read full original descriptionShow less

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: 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; Age ≥18 years at the time of signing informed consent document; ECOG performance status 0-2; Child-Pugh score 5-9 liver function within 28 days of study registration; Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test; Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test; Ability to understand and the willingness to sign a written informed consent document.

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

ClinicalTrials.gov NCT06379256