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Through the neoadjuvant treatment with a combination of Pucotenlimab and Lenvatinib, it eventually enables the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who have indications for nephron-sparing surgery but face significant difficulty in kidney preservation (T1b with an endophytic component ≥75% or T2).
Through the neoadjuvant treatment with a combination of Pucotenlimab and Lenvatinib, it eventually enables the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who have indications for nephron-sparing surgery but face significant difficulty in kidney preservation (T1b with an endophytic component ≥75% or T2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pucotenlimab combined with Lenvatinib as neoadjuvant therapy | Experimental | Pucotenlimab combined with Lenvatinib as neoadjuvant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pucotenlimab Combined With Lenvatinib | Drug | Patients treated by Pucotenlimab combined with Lenvatinib for 3 months before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate (ORR) based on RECIST 1.1 criteria. | At the end of Cycle 6 (each cycle is 14 days) of Pucotenlimab treatment |
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Inclusion Criteria:
Hematology (no blood component or growth factor support therapy in the two weeks before treatment):
Hepatic function:
Coagulation function:
International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
· Willingness and ability of the subject to comply with the scheduled visits, treatment plan, laboratory tests, and other study requirements.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Other (Non U.s.) | 0755 | China |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |