Clear Cell Renal Cell Carcinoma
Conditions
Keywords
Cadonilimab, Neoadjuvant therapy, Clear Cell Renal Cell Carcinoma
Brief summary
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)
Interventions
DRUGCadonilimab Combined With Lenvatinib
* Lenvatinib Treatment Lenvatinib (8mg \[body weight \< 60 kg\] or 12 mg \[body weight ≥ 60 kg\]) orally once daily, with or without food. * Intravenous Infusion of Cadonilimab (Injection) Infuse Cadonilimab at a dose of 6mg/kg intravenously every two weeks, constituting one treatment cycle, a total of 3 or 6 cycles.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary provision of written informed consent prior to any study-related procedures. 2. Age ≥18 years at the time of enrollment; no restriction on sex. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 4. Estimated survival ≥3 months. 5. Pathological confirmation of clear cell RCC or predominantly clear cell renal cell carcinoma by preoperative needle biopsy. 6. Patient willingness to undergo nephron-sparing surgery. 7. 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. 8. At least one measurable lesion per RECIST v1.1 criteria, suitable for repeated accurate measurement. 9. 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): * Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (≥1,500/mm³) * Platelet count (PLT) ≥100 × 10⁹/L (≥100,000/mm³) * Hemoglobin (Hb) ≥90 g/L Hepatic function: * Serum total bilirubin (TBIL) ≤1.5 × ULN * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN * Serum albumin (ALB) ≥28 g/L Coagulation: \- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × ULN 10. 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: 1. Lymph node metastasis 2. Tumor encasing the renal artery 3. Tumor thrombus within the renal vein 4. Diffuse tumor growth without a clear boundary with normal renal parenchyma 5. Poor general condition precluding tolerance of general anesthesia based on anesthesiological assessment 6. Severe cardiovascular or cerebrovascular disease, uncontrolled hypertension, or uncontrolled diabetes mellitus 7. Long-term use of immunosuppressive agents following organ transplantation 8. Current use of immunosuppressive medications 9. Active or clinically apparent infection or fever 10. T-cell lymphoma or multiple myeloma 11. Concurrent other malignancies, currently undergoing treatment for other benign or malignant tumors, or a history of other malignancies within the preceding 6 months 12. Metastatic renal cell carcinoma 13. Receipt of traditional Chinese herbal medicines with antitumor indications or immunomodulatory agents within 14 days prior to the first dose of study drug 14. Ongoing systemic therapy (including thymosin, interferon, or interleukins; local use for control of pleural effusion is permitted) 15. Active or potentially relapsing autoimmune disease; the following conditions are exempt: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism secondary to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type 1 diabetes mellitus requiring only stable-dose insulin replacement therapy 16. Concurrent enrollment in another clinical study, unless it is an observational/non-interventional study or the follow-up phase of an interventional study 17. Known history of psychiatric illness, substance abuse, alcohol dependence, or illicit drug use 18. Pregnant or breastfeeding women 19. Any concurrent disease, prior treatment, or laboratory abnormality that may confound study results, interfere with the subject's full study participation, or indicate that participation may not be in the subject's best interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Evaluation at the end of Cycle 3 or 6 (each cycle is 14 days) of Cadonilimab treatment | Objective Response Rate (ORR) based on RECIST 1.1 criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response rate (MPR) | The evaluation was conducted 5 days after surgery. | The proportion of patients with residual viable tumor cells in tumor specimens and lymph nodes resected after neoadjuvant therapy, which are ≤10%. |
| Nephron-sparing surgery (NSS) success rate | Evaluation at the end of surgery. | The success rate of all enrolled patients undergoing partial nephrectomy. |
| R0 resection rate | The evaluation was conducted 5 days after surgery. | 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). |
| Surgical complication rate | From the end of surgery to three months after surgery | 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 |
| Drug safety profile | During the treatment of combination of Cadonilimab and Lenvatinib. | Incidence and severity of adverse events during the use of Cadonilimab and Lenvatinib. |
Countries
China
Outcome results
None listed