Prospective Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
排除标准
- •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.
结局指标
主要结局
Progression free survival (PFS)
时间窗: 12 months
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.
次要结局
- Overall Response Rate (ORR)(12 months)
- Overall survival (OS)(12 months)
- Incidence and severity of adverse events(12 months)
- Local control (LC)(12 months)
- Time to progression (TTP)(12 months)