Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC (NCT06138496) | Clinical Trial Compass
CompletedPhase 2
Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC
China39 participantsStarted 2023-09-01
Plain-language 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)
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
Exclusion criteria
✕. Lymph node metastasis
✕. Tumor encasing the renal artery
✕. Tumor thrombus within the renal vein
✕. Diffuse tumor growth without a clear boundary with normal renal parenchyma
✕. Poor general condition precluding tolerance of general anesthesia based on anesthesiological assessment
What they're measuring
1
ORR
Timeframe: Evaluation at the end of Cycle 3 or 6 (each cycle is 14 days) of Cadonilimab treatment