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Through the neoadjuvant treatment with a combination of Cadonilimab and Lenvatinib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (tumors measuring 4-7 cm located at the renal hilum or with endophytic growth ≥75% or tumors >7 cm)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cadonilimab combined with Lenvatinib as neoadjuvant therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab Combined With Lenvatinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate (ORR) based on RECIST 1.1 criteria. | Evaluation at the end of Cycle 3 or 6 (each cycle is 14 days) of Cadonilimab treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response rate (MPR) | The proportion of patients with residual viable tumor cells in tumor specimens and lymph nodes resected after neoadjuvant therapy, which are ≤10%. | The evaluation was conducted 5 days after surgery. |
| Nephron-sparing surgery (NSS) success rate |
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Inclusion Criteria:
Voluntary provision of written informed consent prior to any study-related procedures.
Age ≥18 years at the time of enrollment; no restriction on sex.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Estimated survival ≥3 months.
Pathological confirmation of clear cell RCC or predominantly clear cell renal cell carcinoma by preoperative needle biopsy.
Patient willingness to undergo nephron-sparing surgery.
Presence of indications for nephron-sparing surgery but with high surgical complexity: 1) tumors measuring 4-7 cm located at the renal hilum or with endophytic growth ≥75%; or 2) tumors >7 cm.
At least one measurable lesion per RECIST v1.1 criteria, suitable for repeated accurate measurement.
Adequate organ function, with laboratory results during the screening period meeting all of the following criteria:
Hematology (no blood component or colony-stimulating factor support permitted within 2 weeks prior to treatment initiation):
Hepatic function:
Coagulation:
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × ULN
Willingness and ability to comply with scheduled visits, treatment plans, laboratory assessments, and all other study requirements.
Exclusion Criteria:
Patients meeting any of the following criteria will be ineligible for participation:
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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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|
The success rate of all enrolled patients undergoing partial nephrectomy. |
| Evaluation at the end of surgery. |
| R0 resection rate | R0 resection rate refers to the percentage of patients in whom a tumor is surgically removed with no microscopic residual disease. Specifically, it means that after pathological examination of the resected specimen, the tumor margins are negative (no cancer cells are found at the cut edge). | The evaluation was conducted 5 days after surgery. |
| Surgical complication rate | Surgical complication rate is the proportion of patients who experience any unintended, adverse event (such as infection, bleeding, organ injury, or anastomotic leak) following a surgical procedure | From the end of surgery to three months after surgery |
| Drug safety profile | Incidence and severity of adverse events during the use of Cadonilimab and Lenvatinib. | During the treatment of combination of Cadonilimab and Lenvatinib. |
| 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 |