An Open-label, Investigator-initiated, Single Arm, Exploratory Phase 2 Trial Evaluating the Feasibility and Efficiency of PET/CT Directed Free of Therapy Used for Metastatic and Advanced Renal Cell Carcinoma (Perfumer)

NCT07175480 Phase 2 RECRUITING

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.

Details

Lead sponsor	Jinling Hospital, China
Phase	Phase 2
Status	RECRUITING
Enrolment	30
Start date	2025-01-24
Completion	2030-08

Conditions

• Renal Cell Carcinoma (RCC)
• Metastatic Renal Cell Carcinoma (mRCC)

Interventions

• Intermittent PD-1/PD-L1 ICI + VEGFR-TKI

Primary outcomes

• Progression-free survival (PFS) rate — 24 months from treatment initiation
  Proportion of participants alive and without disease progression at 24 months will be assessed according to PERCIST 1.0 criteria.

Countries

China