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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging cohort | Experimental | All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-THP-APN09 PET/CT scans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-THP-APN09 | Diagnostic Test | APN09, nanobody targeting PD-L1, labeled with PET radio-nuclide (68Ga) will be used as a molecular imaging tracer for PET/CT scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MPR | In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%. | After 2-4 cycles of immunotherapy (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression free survival | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Zhu | Contact | 010-88196495 | zhuhuabch@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hua Zhu | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39912938 | Derived | Zhou X, Yan S, Ma X, Zhu H, Liu B, Yang X, Jia B, Yang Z, Wu N, Li N. Efficacy of radiolabelled PD-L1-targeted nanobody in predicting and evaluating the combined immunotherapy and chemotherapy for resectable non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2025 Jun;52(7):2343-2354. doi: 10.1007/s00259-025-07115-3. Epub 2025 Feb 6. | |
| 37555904 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Ma X, Zhou X, Hu B, Li X, Yao M, Li L, Qin X, Li D, Yao Y, Hou X, Liu S, Chen Y, Wang Z, Zhou W, Li N, Zhu H, Jia B, Yang Z. Preclinical evaluation and pilot clinical study of [68Ga]Ga-THP-APN09, a novel PD-L1 targeted nanobody radiotracer for rapid one-step radiolabeling and PET imaging. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):3838-3850. doi: 10.1007/s00259-023-06373-3. Epub 2023 Aug 9. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |