A Pilot Study to Evaluate the Safety and Efficacy of Radiotherapy Plus Sintilimab for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.
详细描述
The patients were divided into two groups. The first group: the single dose of radiotherapy was 200 cGy, once a day, the total dose was 5000 cGy. The second group: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign a written informed consent document.
- •Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches)
- •Has at least 1 measurable lesion
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate organ function
- •Child Pugh class A
- •Life expectancy ≥12 weeks.
- •Antiviral therapy per local standard of care for hepatitis B
- •Woman of child bearing potential must have a negative pregnancy test
- •Must use acceptable form of birth control while on study
排除标准
- •Has previously been performed by raditotherapy for the area to be treated.
- •With extrahepatic metastasis
- •History of hepatic encephalopathy or liver transplantation
- •Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive
- •Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes
- •Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment
- •With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable
- •Evidence of active pulmonary tuberculosis (TB)
- •Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- •History of allergic reactions to related drugs
研究组 & 干预措施
Radiotherapy Plus Sintilimab
HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment.
干预措施: Radiotherapy (Radiation)
Radiotherapy Plus Sintilimab
HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment.
干预措施: Sintilimab (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 1 year
Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria
次要结局
- Overall response rate (ORR)(1 year)
- Progression-free survival (PFS)(2 years)
- Overall Survival (OS)(2 years)