NCT07175480
PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk
Recruiting · Phase 2 · Jinling Hospital, China · registry updated 2025-09-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This phase 2 trial aims to test the feasibility and efficiency of PET/CT-directed treatment interruption strategy in metastatic renal cell carcinoma patients with IMDC favorable/intermediate risk who achieve complete (CMR) or partial metabolic response (PMR) after ≥12 months of first-line PD-1/PD-L1 Immune checkpoint inhibitor (ICI)+ VEGFR-tyrosine kinase inhibitor (TKI) therapy. It helps figure out whether PET/CT can safely direct treatment pause as well as explores a new individualized treatment option based on metabolic imaging for RCC patients.
Inclusion
- Male or female subjects aged ≥ 18 years at time of signing informed consent
- Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV)
- Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
- Eastern Cooperative Oncology Group performance status 0 or 1
- Karnofsky Performance Status (KPS) grade ≥ 70%
- Adequate organ and bone marrow function meeting all laboratory criteria:
Exclusion
- Highly malignant pathology
- Prior systemic therapy for advanced RCC
- Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
- ECOG performance status \>1
- Karnofsky Performance Status (KPS) \<70%
- Inadequate organ and bone marrow function