Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies the investigators have shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, the investigators aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
68Ga-NY104 PET/CT will be performed at baseline, 6 months, 12 months, and 24 months after radiation therapy if the tumor is under control. If CT or MRI shows any suspicious recurrence or metastasis, 68Ga-NY104 PET/CT can be performed at the decision of the urology oncologist or radiation oncologist. The scan begins 1 hour after intravenous injection of 68Ga-NY104.
18F-FDG PET/CT will be performed at baseline and 6 months after radiation therapy. The scan begins 1 hour after intravenous injection of 18F-FDG.
Radiation therapy will be delivered to cover as much metastasis as possible if not all. For new lesions after radiation plus systemic therapy, if the new lesions are considered suitable for RT, RT can be delivered again without changing systemic therapy.
Systemic therapy will be delivered to patients to control the tumor. Possible regimen includes targeted therapy alone, immunotherapy alone, and targeted therapy combined with immunotherapy. The treatment regimen will be decided according to the urology oncologist.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression free survival 2, PFS2
Progression Free Survival 2 (PFS2) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions, when the lesions could not be fully covered by radiotherapy, and the drug regimen had to be changed.
Time frame: the time from the start of RT to 4 years after treatment
Lesion uptake on 68Ga-NY104 PET/CT
Time frame: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT
Lesion uptake on 18F-FDG PET/CT
Time frame: From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT
Number of positive lesions detected on 68Ga-NY104 PET/CT
Time frame: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT
Number of positive lesions detected on 18F-FDG PET/CT
Time frame: From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT
Number of lesions detected combining all available imaging modalities
Time frame: From the start of any imaging modality to 1 week after completion of all imaging modalities
Objective response rate
The percentage of patients with complete remission or partial remission of tumor after treatment.
Time frame: the time from the start of RT to 4 years after treatment
Progression free survival 1, PFS1
Progression Free Survival 1 (PFS1) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions.
Time frame: the time from the start of RT to 4 years after treatment
Disease control rate
The percentage of patients with complete remission, partial remission, or stable disease after treatment.
Time frame: the time from the start of RT to 4 years after treatment
Overall survival
Time frame: the time from the start of RT to 4 years after treatment
Adverse event
The adverse event due to PET/CT and treatment will be recorded according to CTCAE 5.0.
Time frame: the time from the start of RT to 4 years after treatment
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