NCT07442292尚未招募不适用
PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor
Peking University Cancer Hospital & Institute0 个研究点目标入组 40 人开始时间: 2026年2月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 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 radiolabbled peptide 68Ga-cPP-BCH 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;
- •underwent PD-L1 IHC examination before therapy;
- •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;
- •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;
- •Other researchers considered it unsuitable to participate in the trial.
研究组 & 干预措施
Patients take 68Ga-cPP-BCH PET/CT before and after therapy
Patients take paired baseline 18F-FDG PET/CT and 68Ga-cPP-BCH PET/CT within 1 week; and take 68Ga-cPP-BCH PET/CT after therapy
结局指标
主要结局
MPR
时间窗: 3-6 months
major pathological response, in the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
次要结局
- ORR(3-6 months)
研究者
Hua Zhu
Professor
Peking University Cancer Hospital & Institute
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