Status:
NOT_YET_RECRUITING
Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In the current era of immune checkpoint inhibitors (ICI), the role and timing of nephrectomy remains unknown, particularly in cases of residual kidney disease after a major response at metastatic site...
Detailed Description
Patients with metastatic kidney cancer will be treated according to current first-line treatment guidelines. Patients may be included in the study (by signing a consent form) and randomized if a comp...
Eligibility Criteria
Inclusion
- Patient aged ≥ 18 years
- Diagnosed with synchronous metastatic kidney cancer
- With primary tumor still in place (no primary cytoreductive nephrectomy)
- Having received systemic ICI immunotherapy-based combination therapy
- In CR or mPR (defined as \>75% response in metastatic lesions from baseline) according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), excluding the primary renal lesion.
- Signed consent to participate
- Affiliated to the national social security scheme or beneficiaries of such a scheme
Exclusion
- Women who are or may become pregnant (without effective contraception) or who are breast-feeding.
- Person in an emergency situation or unable to give consent.
- An adult under legal protection (guardianship, curators or safeguard of justice),
- Inability to undergo medical follow-up for geographical, social or psychological reasons.
- Patients who have undergone prior cytoreductive nephrectomy
- Patients considering nephrectomy for symptomatic disease, but without major response (CR or mPR) in metastatic disease
- Patients with non-metastatic disease at diagnosis who have received ICI in a neo-adjuvant setting
- Patients with contraindications to surgery or ineligible for nephrectomy
- Patients not wishing to undergo nephrectomy
- Patients with end-stage renal disease
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06882486
Start Date
September 1 2025
End Date
September 1 2030
Last Update
March 18 2025
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