CAIX PET/ CT Guided Radiation Therapy in CcRCC.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
PETCT-guided radiation therapy
RadiationPETCT-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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: mccRCCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS
time from the start of treatment to progression
Time frame
2 yearSecondary outcomes
1
local control rate
local control rate of all irradiated lesions
Time frame
2 year2
Duration of current-line systemic therap
Time (months) from the start date of the first radiotherapy course to the date when the current-line systemic therapy regimen must be changed due to disease progression. Oligoprogression managed with radiotherapy without changing systemic therapy will not be counted as an event.
Time frame
From first radiotherapy to change of systemic therapy due to disease progression (up to 3 years).Sponsors and contacts
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Source ClinicalTrials.gov