RecruitingPhase 2NCT07175480

PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk

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

Sponsor

Jinling Hospital, China

Enrollment

30 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether PET/CT scans can guide treatment breaks ("therapy holidays") for people with metastatic kidney cancer (renal cell carcinoma, or RCC) who have responded well to their current treatment. The goal is to spare patients from ongoing treatment when it may not be necessary. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with locally advanced or metastatic kidney cancer (Stage IV RCC) - Your cancer is classified as favorable or intermediate risk using IMDC criteria - Your overall health and activity level is good (ECOG status 0-1, Karnofsky score 70% or higher) - Your organ and bone marrow function meets the laboratory requirements **You may NOT be eligible if...** - Your cancer is high risk per IMDC criteria - You have poor organ function or blood count abnormalities - You have other conditions that would complicate treatment or imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntermittent PD-1/PD-L1 ICI + VEGFR-TKI

Any PD-1/PD-L1 inhibitor or VEGFR-TKI that is commercially marketed, regulatory-approved and reimbursed under public health plans.Dose as recommended by the manufacturer.