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| ID | Type | Description | Link |
|---|---|---|---|
| ALTER-UC-011 | Other Identifier | Same as current |
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Evaluation of long-term renal function improvement, surgical safety, as well as efficacy and safety of preoperative anlotinib hydrochloride capsules combined with benmelstobart injection versus surgery in patients with localized renal cell carcinoma undergoing partial nephrectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib + Benmelstobart | Experimental | Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)； Benmelstobart 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle |
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| Upfront partial nephrectomy (standard care) | Active Comparator | Patients receive upfront partial nephrectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy | Drug | Patients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma. |
| Measure | Description | Time Frame |
|---|---|---|
| Pentafecta Achievement | It includes: negative surgical margin, warm ischemia time (WIT) ≤ 25 minutes, no perioperative complications, estimated glomerular filtration rate (eGFR) preservation ≥ 90% at 9-12 months postoperatively, and no increase in chronic kidney disease (CKD) stage at 9-12 months postoperatively. The eGFR preservation rate is calculated as the percentage of the postoperative eGFR relative to the preoperative baseline eGFR. An increase in CKD stage is defined as progression to Stage III, IV, or V; progression from Stage I to Stage II is not considered an increase in CKD stage. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Primary tumor partial response (PR) rate in the experimental arm | Through study completion, an average of 1 year | |
| Safety | Number of participants with treatment-related adverse events as assessed by CTCAE 6.0 To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
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| Partial nephrectomy | Procedure | Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma. |
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| Through study completion, an average of 2 years |
| 2-year DFS Rate | 2-year Disease-Free Survival Rate | 2-years |
| R.E.N.A.L. score changes in the experimental group | The R.E.N.A.L. Nephrometry Score is a 4-12 point anatomical classification system for renal tumors, with each letter representing a key feature scored as 1, 2, or 3 points, as follows: (R) Radius (Maximum tumor diameter, cm)； (E) Exophytic/endophytic properties (Tumor growth pattern)； (N) Nearness to the collecting system or renal sinus (Tumor distance to collecting system/renal sinus, mm)； (A) Anterior/posterior location； (L) Location relative to the polar line (Relationship to renal polar line; suffix (h) is added if the tumor is adjacent to major renal artery or vein) | Through study completion, an average of 1 year |
| Jilin Provincial Cancer Hospital | Changchun | China |
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| Hunan Provincial Cancer Hospital | Changsha | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | China |
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| Yunnan Provincial Cancer Hospital | Kunming | China |
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| Nanjing Drum Tower Hospital | Nanjing | China |
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| The First Affiliated Hospital of Guangxi Medical University | Nanning | China |
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| The Affiliated Hospital of Qingdao University | Qingdao | China |
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| Huadong Hospital Affiliated to Fudan University | Shanghai | China |
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| Liaoning Provincial Cancer Hospital | Shenyang | China |
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| Shanxi Province Cancer Hospital | Taiyuan | China |
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| Tianjin Medical University Cancer Institute and Hospital | Tianjin | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 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 |
| 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 |
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