A Retrospective Clinical Study of Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
The goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy combined with PD-1 blockers for LAPC and LRPC. The patients, diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent pancreatic cancer (LRPC). LRPC or LAPC, undergoing SABT and PD-1 blockers in our hospital from December 2020 to April 2023 were reviewed consecutively. All patients provided written informed consent before treatment. The study was conducted in accordance with the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee of Peking University Third Hospital.
详细描述
The goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with PD-1 blockers for LAPC and LRPC. The patients, diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent pancreatic cancer (LRPC). LRPC or LAPC, undergoing SBRT and PD-1 blockers in our hospital from December 2020 to April 2023 were reviewed consecutively. The schedule of SBRT is 25 to 50 Gy in 5 fractions and the PD-1 blockers are monoclonal antibodies targeted to PD-1 molecules on the T lymphocytes.
All patients provided written informed consent before treatment. The study was conducted in accordance with the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee of Peking University Third Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LRPC confirmed by pathologic or imaging diagnosis and LAPC confirmed by pathology;
- •disease size ≥1 cm;
- •adequate hematological reserves, hepatic function, renal function and heart function;
- •expected survival > 3 months.
排除标准
- •unconfirmed mass;
- •The upper abdomen was previously treated with radiotherapy;
- •the patients previously underwent immunotherapy of PD-1 or PD-L1 monoclonal antibody;
- •a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency or other immune-related conditions requiring long-term oral hormone therapy;
- •patients with active infectious disease, trauma and severe wounds;
- •patients with any mental disorder;
- •patients with other somatic comorbidities of clinical concern;
- •pregnancy and lactation.
研究组 & 干预措施
SBRT+PD-1 blockers
pembrolizumab (200 mg every 3 weeks), carelizumab (200 mg every 3 weeks), tislelizumab (200 mg every 3 weeks), sintilimab (200 mg every 3 weeks), zimberelimab (240 mg every 3 weeks) until the tumor progressed or the side effects became intolerable.
干预措施: Stereotactic body radiotherapy (SBRT) (Radiation)
SBRT+PD-1 blockers
pembrolizumab (200 mg every 3 weeks), carelizumab (200 mg every 3 weeks), tislelizumab (200 mg every 3 weeks), sintilimab (200 mg every 3 weeks), zimberelimab (240 mg every 3 weeks) until the tumor progressed or the side effects became intolerable.
干预措施: PD-1 blocking antibody (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 12 months
PFS was defined as the time from SBRT to disease progression
次要结局
- Overall survival (OS)(18 months)
- Adverse Events (AEs)(18 months)
- local progression-free survival (LPFS)(12 months)
- Pain relief rate (PRR）(18 months)