Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, 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 (T1b with an endophytic component ≥75% or T2)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pucotenlimab combination with Vorolanib as neoadjuvant therapy | Experimental | Vorolanib Treatment Vorolanib 200mg orally once daily, with or without food.Intravenous Infusion of Pucotenlimab(Injection) Infuse Pucotenlimab at a dose of 200mg intravenously every three weeks, constituting one treatment cycle, the maximum duration of treatment should not exceed 4 cycles.Perform imaging evaluation after 2 cycles, including renal CT plain scan+enhancement, measurement of tumor volume, and evaluation of ORR. If PD is detected in the first imaging assessment, the study will be terminated. According to the current diagnosis and treatment routine, communicate with the patient about the follow-up treatment plan:Radical nephrectomy; Utilization of other targeted therapies; Combination targeted therapy with immunotherapy. If the tumor shrinks significantly and the surgeon evaluates that partial nephrectomy can be safely performed, drug therapy should be stopped and partial nephrectomy should be performed; otherwise, continue treatment to 4 cycles before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pucotenlimab combination with Vorolanib | Drug | 3.7.1 Vorolanib Vorolanib 200mg PO QD, taken with or without food. 3.7.2 Pucotenlimab Intravenous infusion of 200mg of Pucotenlimab (injection), once every 3 weeks, as one treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) based on RECIST 1.1 criteria. | Evaluation at the end of Cycle 2 or Cycle 4 (each cycle is 21 days) of Pucotenlimab treatment |
Not provided
Not provided
Inclusion Criteria:
Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment):
a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); b. Platelet count (PLT) ≥ 100 × 109/L (100000/mm3); c. Hemoglobin (HB) ≥ 90 g/L;
Liver:
Coagulation function:
International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN 11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
Exclusion Criteria:
• Renal vein cancer thrombus
• Diffuse tumor growth, with no clear boundary from normal renal parenchyma
• General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery
• Have serious cardiovascular and cerebrovascular diseases, uncontrollable
• hypertension and diabetes
• Patients who have long-term use of immunosuppressants after organ transplantation
• Patients who are currently using immunosuppressive drugs
• Patients with clear infection or fever
• Patients with T-cell lymphoma and myeloma
• Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months
• Metastatic renal cell carcinoma.
• Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug
• Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).
• Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.
• Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.
Known history of mental illness, drug abuse, alcoholism, or drug use.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiling Zhang, M.D | Contact | +862087342318 | zhangzhl@sysucc.org.cn | |
| Yulu Peng, M.D | Contact | +862087342318 | pengyl1@sysucc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Other (Non U.s.) | 0755 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709220 | vorolanib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |