To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic renal cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Dose fractionation: 39-48Gy/3f or 40-50Gy/5f, alternative 20-50Gy/5f if OAR dose-limited. Dose adjusted per radiation toxicities during treatment.
Oral anti-angiogenic agent, 12 mg qd fasting, 21d/cycle (2w on/1w off)
Intravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion
Fujian Cancer Hospital
Fuzhou, Fujian, China
Objective Response Rate (ORR)
Time frame: Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month.
Progression-Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease Control Rate (DCR)
Time frame: Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and regular follow-up during consolidation therapy, from enrollment to 36 month.
Overall Survival (OS)
Time frame: Followed up for the entire study period until patient death or study conclusion, from enrollment to 36 month.
Objective Response Rate in the Field of Irradiation
Time frame: Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month..
Objective response rate (ORR) of irradiated versus non-irradiated lesions assessed by RECIST v1.1
Time frame: Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months.
Incidence of treatment-related adverse events (TRAEs) assessed by CTCAE v5.0
Time frame: From baseline through study treatment period, up to 2 years.
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