Research for the Molecular Imaging of the PD-L1 Targeting Tracer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- SUV
研究概览
简要总结
To use the molecular probe PET radionuclide (Ga-68 or F-18) WL12 peptide to detect the expression of PD-L1 in the primary and metastatic lesions in patients with solid tumor; to detect the expression heterogeneity of PD-L1 in the lesion and inter-lesions; to observe the change of PD-L1 expression in the course of treatment. To provide an approach for screening patients with high expression of PD-L1, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the Individualized antitumor treatment of targeted drugs.
详细描述
In many clinical trials, Anti-PD-1/PD-L1 mAbs have achieved great success than expected in a variety of refractory and recurrent tumor patients. The latest research shows that it is not all cancer patients would respond to Anti-PD-1/PD-L1 mAbs. At present, immunohistochemistry (IHC) is still a common method to screen patients that will benefit from this therapy by detecting the expression level of PD-1 and PD-L1. However, the results of IHC were not very exact because of limitations of IHC such as the heterogeneity of expression, the influence of host cell PD-L1 expression and the changes in the course of the disease. Moreover, the tumor tissue used in IHC must obtained through the invasive method. It is difficult to dynamically monitor the expression level of PD-1 / PD-L1 during the treatment. Immuno-PET molecular imaging By radiolabeling Anti-PD-1/PD-L1 mAbs with radionuclides can be used to noninvasive assessment of biodistribution of monoclonal antibodies and provide a new strategy for patient screening.
In this study, 18F-WL12 or 68Ga-WL12 PET / CT imaging will be performed in patients with solid tumors to access the potential of 18F-WL12 or 68Ga-WL12PET / CT to screen patients who can benefit from JS001 treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •1. Aged >18 years old; ECoG 0 or 1;
- •2. Patients with solid tumors;
- •3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
- •4. life expectancy >=12 weeks.
排除标准
- •1. Significant hepatic or renal dysfunction;
- •2. Is pregnant or ready to pregnant;
- •3. Cannot keep their states for half an hour;
- •4. Refusal to join the clinical study;
- •5. Suffering from claustrophobia or other mental diseases;
- •6. Any other situation that researchers think it is not suitable to participate in the experiment.
结局指标
主要结局
SUV
时间窗: 2 years
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT
次要结局
未报告次要终点
研究者
Hua Zhu
Associate Professor
Peking University Cancer Hospital & Institute