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Recruiting Not applicable NCT07540260

CAIX PET/ CT Guided Radiation Therapy in CcRCC.

No applicable phase (e.g. observational)
Conditions: Radiation Therapy Metastatic Renal Cancer Recurrent Renal Cell Cancer

Sponsor: Peking University First Hospital

trial.available_in: БГ
Overview
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).
Who can participate
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
Interventions
PETCT-guided radiation therapy
RADIATION
Locations 1
China (1)
Peking University First Hospital
Beijing , Beijing Municipality
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.11.2025
Completion date
31.12.2030
Registry ID
NCT07540260
Source
clinicaltrials.gov
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