PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Highly malignant pathology
Prior systemic therapy for advanced RCC
Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
ECOG performance status >1
Trial design
Treatments tested in this trial
- Intermittent PD-1/PD-L1 ICI + VEGFR-TKI
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov