Exploring the efficacy and safety of recombinant human vascular endothelial inhibitor (Endo) in combination with Bragg therapy in advanced refractory non-small cell lung
Radiotherapy: Start radiotherapy on the first day of treatment, as described in 6.2 above; GM-CSF treatment: GM-CSF 200 μg on the first day of treatment, administered subcutaneously daily for 7 days; IL-2 treatment. 2 million IU of IL-2 on the day after GM-CSF, administered subcutaneously daily for 7 days; Immunotherapy: PD-1/PD-L1 inhibitors within one week of radiotherapy; Recombinant human vascular endothelial inhibitor (Endo): Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h starting on the first day of treatment, every 21 days for a minimum of ≥ 2 cycles of this combination therapy. Maintenance treatment phase: Maintenance with PD-1/PD-L1 inhibitor in combination with recombinant human vascular endothelial inhibitor (Endo) until progression or intolerable side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
hypofractionated radiotherapy/SBRT
PD-1/PD-L1 inhibitor within one week of radiotherapy
IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
The Second Affiliated Hospital of SchoowUniversity
Suzhou, China
RECRUITINGoverall response rate(ORR)
ORR is defined as the proportion of patients who have a partial (PR) or complete response (CR) to therapy among the total number of evaluable patients.
Time frame: six weeks
Disease control rate (DCR)
the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)
Time frame: six weeks
Progression free survival (PFS)
The time from commencement of treatment to disease progression or death from any cause.
Time frame: six weeks
Overall survival (OS)
The time from the first day of enrollment to death from any cause.
Time frame: six weeks
Incidence of adverse events
the rate of AE
Time frame: six weeks
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IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h was started on the first day of treatment, every 21 days for a minimum of ≥ 2 cycles of this combination therapy.