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

Официальное название

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

Обзор

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.

Вмешательства

• Лучевая терапия Photon or proton radiotherapy
  * 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

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: 12 months]

Вторичные конечные точки (5)

• Local control (LC) [Срок оценки: 12 months]
• Time to progression (TTP) [Срок оценки: 12 months]
• Overall Response Rate (ORR) [Срок оценки: 12 months]
• Overall survival (OS) [Срок оценки: 12 months]
• Incidence and severity of adverse events [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• Chang Gung Memorial Hospital at Linkou — Taoyuan City

Идентификаторы

NCT: NCT06379256 · 202400364B0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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