The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and rhGM-CSF is safe, effective in the treatment of oligometastatic stage IV NSCLC patients.
The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of oligometastatic stage IV NSCLC patients who were PR or SD after first-line chemotherapy,and to observe the abscopal effect, whether the scheme can improve PFS and OS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
rhGM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. rhGM-CSF can promote the maturation of dendritic cells and macrophage, increase their antigen presentation ability.
Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.
Radiotherapy promotes the release of tumor antigen
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
RECRUITINGSHANDONG Cancer Hospital
Jinan, Shandong, China
RECRUITINGPFS
Progression-Free-Survival
Time frame: 2 years
Abscopal effect rate
Radiotherapy-induced immune-mediated tumour regression at sites distant to the irradiated field
Time frame: At the time point of 4 weeks after completion of rhGM-CSF
OS
Overall survival
Time frame: 2 years
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Other chemotherapy drugs,such as Docetaxel, gemcitabine