Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 sites. In these cases, the rationale for a delayed nephrectomy is that it might achieve a long-term response. This strategy could allow some patients to discontinue treatment and maintain tumor response. Furthermore, this approach might provide a potentially curative option for patients with metastases that are managed with and responding to ICI. Regarding the results of our first retrospective cohort data (showing that two thirds of patients are free from recurrence without systemic treatment after nephrectomy), we designed a non-comparative randomized phase II trial assessing progression-free survival of patients with complete response or major partial response after ICI-based treatment, operated on delayed nephrectomy with discontinuation of systemic therapy (experimental arm) and in patients managed with continuation of systemic therapy without nephrectomy (control arm). In a de-escalation approach, this strategy may have sense to allow patients with an excellent response to immunotherapy to stop systemic treatment with a curative objective and a substantial impact from a medico-economic point of view.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Diagnoza: rak nerki z przerzutami (rozsianiem)
- •Pierwotny guz nerki jeszcze na miejscu (nie usunięty wcześniej)
- •Leczenie immunoterapią (inhibitory punktów kontroli immunologicznej)
- •Bardzo dobra odpowiedź na leczenie (zmniejszenie przerzutów o ponad 75%)
- •Podpisana zgoda na uczestnictwo w badaniu
- •Ubezpieczenie w polskim systemie zdrowotnym
✗ Disqualifies
- •Kobiety w ciąży, mogące zajść w ciążę lub karmiące piersią
- •Niemożność udzielenia świadomej zgody
- •Pod opieką sądową lub ubezwłasnowolnieni
- •Niemożność regularnych wizyt kontrolnych
- •Wcześniejsze usunięcie nerki
- •Brak dobrej odpowiedzi na immunoterapię w przerzutach
- •Schorzenie nerek w stadium końcowym
- •Przeciwwskazania medyczne do operacji
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Institut Paoli-Calmettes
Marseille, France
Trial contact
Jihane PAKRADOUNI
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/15/2026.
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