Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALrhGM-CSF
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.
DRUGPemetrexed
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.
RADIATIONLocal Radiotherapy
Radiotherapy promotes the release of tumor antigen
DRUGSingle agent
Other chemotherapy drugs,such as Docetaxel, gemcitabine
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy; 2. Patients who were oligometastasis evaluated by PET-CT or other examinations after first-line chemotherapy. Eligible patients should have 2 to 5 distant metastases (at least 2 metastases were suitable for low fractionated radiotherapy). At least one distant measurable lesion outside the radiation sites. 3. Age varied from 18 to 75 years old. 4. ECOG performance status 0-2. 5. Expected lifespan ≥3 months. 6. Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥90 g/L. 7. Able to understand and give written informed consent and comply with study procedures.
Exclusion criteria
1. Allergy of rhGM-CSF and its accessories. 2. Disease of systemic immune or immune disorders. 3. Histology confirmed small cell carcinoma or other malignant compositions in the cancer tissue. 4. Patients with thrombotic disease or platelets ≥600×109/L 5. Cancer history within 5 years apart from NSCLC before enrollment. 6. Tumor related immunotherapy within 4 weeks, including but not limited to immune cell therapy, tumor vaccine therapy, Immune checkpoint therapy, and other immunomodulators (such as thymosin, lentinan) except for rhGM-CSF. 7. The abnormality of kidney , heart or lung functions（serum creatinine, Cr\>177mol/L; serum AST or ALT more than 2 times above normal limits; total bilirubin, TBIL\>34mol/L）. 8. HIV virus, hepatitis C virus or T lymphocyte virus (type1 or type 2) infection and active hepatitis or other uncontrolled infections. 9. Women in pregnancy or lactation. 10. Others who do not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 years | Progression-Free-Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abscopal effect rate | At the time point of 4 weeks after completion of rhGM-CSF | Radiotherapy-induced immune-mediated tumour regression at sites distant to the irradiated field |
| OS | 2 years | Overall survival |
Countries
China
Contacts
Primary ContactMing Huan Li, doctor
Backup ContactJINMING YU, doctor
Outcome results
None listed