EICHORCondition: Hepatocellular Carcinoma · Sponsor: Chang Gung Memorial Hospital
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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.
This description comes directly from the study's public registry record.
Rodney Cheng-En Hsieh, MD, PhD · +886-3-3281200 · chsieh@cgmh.org.tw
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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.
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| Chang Gung Memorial Hospital at Linkou | Taoyuan City, Taiwan, Taiwan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06379256