NCT05917431招募中2 期
Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The goal of this phase 2 prospective clinical trial is to learn about the efficacy and safety of stereotactic body radiation therapy (SBRT) plus immunotherapy and targeted therapy in patients with unresectable or oligometastatic hepatocellular carcinoma (HCC).
The main question to answer is: Whether combing SBRT with immunotherapy and targeted therapy could prolong PFS. Participants will receive SBRT to all visible lesions and concurrent systemic immunotherapy and targeted therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •Eastern Cooperative Oncology Group performance status of 0-1
- •clinical or pathological diagnosis of HCC
- •with unresectable locally advanced or oligometastatic HCC (metastatic lesions ≤ 5, metastatic organs ≤ 3, may involve extrahepatic lymph nodes or distant organs apart from brain)
- •at least one measurable lesion according to mRECIST criteria
- •all lesions could be included in radiation target volume
- •Child-Pugh A or B (7 scores) liver function
- •patients are allowed to receive systemic therapy previously other than tislelizumab plus regorafenib
- •adequate hematological and renal function
- •life expectancy ≥ 3 months；
- •willing to participate in the study and give written informed consent
排除标准
- •a history of liver transplantation
- •with severe cirrhosis complications, including a history of esophagogastric variceal bleeding, hepatic encephalopathy, and massive ascites
- •with active autoimmune diseases or a history of autoimmune disease
- •with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
- •allergic to the ingredient of tislelizumab or regorafenib
- •with recurrent lesions treated with radiotherapy previously
- •prescribed radiation does could not be delivered due to dose limits to organs at risk (OAR)
- •intolerable to radiation or systemic treatment because of cardiac insufficiency, uncontrolled high blood pressure
- •a history of other malignancies, except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
结局指标
主要结局
PFS
时间窗: From the date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Progression-free survival
次要结局
- OS(From the date of treatment beginning until the date of death from any cause, assessed up to 48 months)
- Recurrence pattern(From the date of treatment beginning until the date of last follow-up, assessed up to 48 months)
研究者
Wang weihu
Professor
Peking University Cancer Hospital & Institute
研究点 (1)
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