NCT04564482招募中不适用
Programmed Death-ligand 1 Positron Emission Tomography Imaging During Neoadjuvant (Chemo)radiothErapy in Esophageal and Rectal Cancer (PETNEC): a Prospective Non-randomized Open-label Single-center Pilot Study
Johannes Laengle, MD, PhD2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intratumoral changes of PD-L1 expression during neoadjuvant CRT/SCPRT
研究概览
简要总结
The overall aim of this pilot study is to prospectively monitor programmed death-ligand 1 (PD-L1) expression dynamics in vivo, during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT) in rectal and esophageal cancer by a positron emission tomography (PET) imaging approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •18 years of age and older
- •All sexes
- •Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers)
- •Medical need for a neoadjuvant CRT/SCPRT
- •Suitable to withstand the course of neoadjuvant CRT/SCPRT
- •Written informed consent form (ICF) for participation in the study
排除标准
- •Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend)
- •Previous surgery of the tumor other than biopsy
- •Pregnancy, breastfeeding or expectancy to conceive
- •Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy
- •Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy
- •Hepatitis B or C
- •Human immunodeficiency virus (HIV)
- •Immunodeficiency
- •Allogeneic tissue or solid organ transplantation
- •Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs
- •Active non-infectious pneumonitis
- •Active infection requiring systemic therapy
- •Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- •Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers
- •Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment
- •Participants with serious or uncontrolled medical disorders
- •Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males > 450 ms and > 470 ms in females, participants with history of myocarditis)
- •Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)
- •Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness
结局指标
主要结局
Intratumoral changes of PD-L1 expression during neoadjuvant CRT/SCPRT
时间窗: 3 weeks
Intratumoral PD-L1 expression dynamics induced by neoadjuvant CRT/SCPRT will be assessed by 89Zr-atezolizumab PET imaging (day 0 and between day 10-14).
次要结局
- Radiographic therapy response(12 weeks)
- Pathological therapy response(12 weeks)
研究者
Johannes Laengle, MD, PhD
Sub-Investigator
Medical University of Vienna
研究点 (2)
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