CAIX PET/CT–guided radiation for clear cell kidney cancer

CAIX PET/ CT Guided Radiation Therapy in CcRCC.

This trial will try using CAIX-targeted PET/CT scans plus FDG PET/CT to guide focused stereotactic radiation alongside standard targeted therapy and anti‑PD‑1 immunotherapy for adults with recurrent or metastatic clear cell kidney cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07540260 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm study enrolling roughly 70 adults with recurrent or metastatic clear cell renal cell carcinoma who are receiving first-line targeted therapy combined with anti‑PD‑1 immunotherapy. Participants will undergo dual PET/CT imaging (FDG PET/CT and a CAIX-targeted PET/CT) to map disease sites and guide radiotherapy planning. When feasible, PET-visible lesions will be treated with image-guided stereotactic ablative radiotherapy (SABR), with a multidisciplinary team confirming that ≥75% of detectable lesions can be targeted. Patients will be followed for progression-free survival, local control of treated lesions, and treatment-related adverse events at a single center in Beijing.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed clear cell renal cell carcinoma that is recurrent or metastatic, who are on or planned for first-line targeted therapy plus anti‑PD‑1 immunotherapy, have access to dual PET/CT imaging, and have disease judged amenable to treating ≥75% of lesions with SABR.

Not a fit: Patients who cannot safely receive stereotactic radiotherapy, have uncontrolled serious comorbidities or active infection, are pregnant or breastfeeding, are unwilling or unable to comply with study procedures, or whose disease cannot be imaged or targeted sufficiently for SABR may not receive benefit.

Why it matters

Potential benefit: If successful, this approach could improve local control of metastatic lesions and potentially prolong progression-free survival by directing precise radiotherapy to biologically active tumors.

How similar studies have performed: Stereotactic ablative radiotherapy has shown promise for oligometastatic renal cell carcinoma in prior studies, but CAIX-targeted PET is a relatively new imaging approach with limited published outcome data to date.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Mingwei Ma

Conditions: Radiation Therapy, Metastatic Renal Cancer, Recurrent Renal Cell Cancer, SBRT