Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients
NCT ID: NCT03489616
Last Updated: 2018-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2018-01-15
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiotherapy+chemotherapy+ rhGM-CSF
Patients with PR or SD after first-line chemotherapy will be treated with pemetrexed on d1 (500mg/m2) or other single agent on d1, d8. Local radiotherapy dose will be\> 4Gy per time（or BED \>45Gy） from day 2 to day 15 in a cycle of 21 days. Subcutaneous injection of rhGM-CSF (200ug/m² per day) will be executed 24 hours after chemotherapy. Repeat in the second metastatic lesions.
rhGM-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.
Pemetrexed
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.
Local Radiotherapy
Radiotherapy promotes the release of tumor antigen
Single agent
Other chemotherapy drugs,such as Docetaxel, gemcitabine
Single agent maintenance therapy
Maintenance treatment by single agent in a cycle of 21 days.
Single agent
Other chemotherapy drugs,such as Docetaxel, gemcitabine
Interventions
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rhGM-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.
Pemetrexed
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.
Local Radiotherapy
Radiotherapy promotes the release of tumor antigen
Single agent
Other chemotherapy drugs,such as Docetaxel, gemcitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Jinming Yu
chief physician
Principal Investigators
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JINMING YU, doctor
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Locations
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Shandong Cancer Hospital and Institute
Jinan, Shandong, China
SHANDONG Cancer Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18.
Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24.
Other Identifiers
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SDCH201701LC
Identifier Type: -
Identifier Source: org_study_id
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