CAIX PET/ CT Guided Radiation Therapy in CcRCC.

NCT07540260 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Not applicable

Started

2025-11-01

Last updated

2026-04-20

Condition(s) studied

Radiation TherapyMetastatic Renal CancerRecurrent Renal Cell Cancer

Investigational drug(s) / intervention(s)

PETCT-guided radiation therapy

PETCT-guided radiation therapy: PETCT-guided radiation therapy: All patients will undergo both FDG PET/CT and CAIX PET/CT. Radiotherapy will be planned and delivered based on the imaging findings, with the goal of achieving the most comprehensive feasible (all-site) coverage whenever appropriate.

Study summary

This is a prospective, single-arm study in adults with recurrent or metastatic clear cell renal cell carcinoma (ccRCC). Participants will receive standard systemic therapy (targeted therapy plus anti-PD-1 immunotherapy) and undergo dual PET/CT imaging (FDG PET/CT and a CAIX-targeted PET/CT) to map disease sites. When feasible, PET/CT-visible lesions will be treated with image-guided stereotactic ablative radiotherapy (SABR). Patients will be followed to evaluate progression-free survival, local control of treated lesions, and treatment-related adverse events (planned enrollment: \~70).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Adults (≥18 years) Histologically confirmed clear cell renal cell carcinoma Recurrent or metastatic disease Planned or ongoing first-line systemic therapy (targeted therapy plus anti-PD-1 immunotherapy) Dual PET/CT imaging available (FDG PET/CT and CAIX-targeted PET/CT) and eligible for radiotherapy planning Multidisciplinary assessment confirms radiotherapy is feasible to treat ≥75% of detectable lesions Able to provide written informed consent Exclusion Criteria: Unable to receive stereotactic radiotherapy as planned Uncontrolled serious comorbidities or active infection Pregnant or breastfeeding Unable or unwilling to comply with study procedures and follow-up

Primary outcome measure(s)

PFS — 2 year
time from the start of treatment to progression

Trial sites (1)

Facility	City	Region	Status
Peking University First Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07540260 on ClinicalTrials.gov ↗ ← All trials in China