NCT05156515Unknown不适用
PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- MPR
研究概览
简要总结
The objective of this study is to construct a noninvasive approach using 68Ga-THP-APN09 PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75, male and female, with ECOG score of 0 or 1;
- •Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months);
- •The expected survival was more than 26 weeks;
- •Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT;
- •According to RECIST1.1, there was at least one measurable target lesion;
- •Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
- •Understand and sign informed consent voluntarily with good compliance.
排除标准
- •The function of liver and kidney was seriously abnormal;
- •Preparation for pregnant, pregnant and lactating women;
- •Inability to lie flat for half an hour;
- •Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial.
结局指标
主要结局
MPR
时间窗: After 2-4 cycles of immunotherapy (each cycle is 28 days)
In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
次要结局
- PFS(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
研究者
Hua Zhu
Associate Professor
Peking University Cancer Hospital & Institute
研究点 (1)
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