Phase II Trial of CD70-Targeted Immuno-PETCT to Guide Treatment Pause in Metastatic Clear Cell Renal Cell Carcinoma with Favorable or Intermediate IMDC Risk

What this Trial Is About

Researchers are evaluating a treatment pause strategy guided by CD70-targeted immuno-PETCT imaging in patients with metastatic clear cell renal cell carcinoma mccRCC who have favorable or intermediate risk according to IMDC criteria. The study aims to determine if patients who achieve disease control and metabolic response after 12 months of first-line PD-1PD-L1 immune checkpoint inhibitors combined with VEGFR tyrosine kinase inhibitors can safely stop treatment to improve quality of life without reducing treatment effectiveness. Participants will receive standard first-line combination therapy with PD-1PD-L1 inhibitors and VEGFR-TKI for about 12 months. After this period, patients will be assessed by CT scans and CD70 immuno-PETCT imaging. Those meeting specific imaging criteria indicating disease control and metabolic response will enter a treatment holiday where systemic therapy is paused and they are closely monitored. If disease progression or symptoms occur, the original treatment will be restarted. During the holiday, patients undergo regular anatomical monitoring every 8 to 12 weeks and molecular imaging every 24 weeks, along with blood tests for early warning biomarkers. Throughout the study, participants will provide biological samples and complete quality of life questionnaires at multiple time points. The study measures treatment-free survival, overall and progression-free survival, safety, patient-reported outcomes on quality of life and mental health, and cost-effectiveness. Follow-up continues up to three years from treatment start, with evaluation of responses and outcomes after treatment pauses to balance survival benefits with quality of life in advanced RCC.

CD70-Targeted Immuno-PET/CT-Directed Free of Therapy Used for mccRCC Patients With IMDC Favorable or Intermediate Risk