The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in second-line chemotherapy.
Metastasis lesion of stage IV NSCLC will be treated with a SBRT of 50Gy/4-10F from day 1 to day 14 in one cycle. Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.Thymosin Alpha 1(1.6mg Biw) will be Subcutaneous injection from the fist week to the 12th weeks, Efficacy evaluation, especially abscopal effect evaluation, will be conducted at the end of therapy and every month after that. Adverse events will be recorded according to NCI-CTC version 4.03.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Stereotactic body radiotherapy A type of radiation therapy to the Metastasis lesion
Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.
Thymosin Alpha 1(1.6mg Biw)will be executed from the fist Week to the 12th Weeks.
First affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGabscopal effect rate
Time frame: at the time point of 4 weeks after completion of the combined treatment
overall survival
Time frame: 1 year after completion of the combined treatment
Incidence of Adverse events
Time frame: 1 year after completion of the combined treatment
objective response rate
Time frame: 4 weeks after completion of the combined treatment
Incidence of immune-related adverse events
Time frame: 1 year after completion of the combined treatment
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