A Phase 2 interventional study of Stereotactic body radiotherapy and rhGM-CSF in Carcinoma, Non-Small-Cell Lung, sponsored by Wuhan University. Withdrawn at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by Wuhan University · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of stage IV NSCLC patients who failed in second-line chemotherapy.
Metastasis lesion will be treated with a SBRT of 50Gy/5F from day 1 to day 5 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. 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.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →Wuhan University is the lead sponsor of 45 studies on the registry; 14 are open to participants now.
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Stable lab values:
Hematological: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) ≤1.5× the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels >1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels >1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver metastases ,globulin≥20 g/L, albumin≥30 g/L.
Exclusion criteria:
Metastasis lesion will be treated with a SBRT of 50Gy/5F from day 1 to day 5 in a cycle of 21 days.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.
Radiation: Stereotactic body radiotherapy · Drug: rhGM-CSF
A type of radiation therapy
Also known as: SBRT, SABR
Immune modulating agents
Also known as: Recombined human granulocyte-macrophage colony stimulating factor
abscopal effect rate
Time frame: at the time point of 4 weeks after completion of rhGM-CSF
overall survival
Time frame: 2 years
Incidence of Adverse events
All adverse events will be recorded
Time frame: 2 years
progression free survival
Time frame: 2 years
objective response rate
Time frame: 2 years
abscopal effect rate
Time frame: at the time point of 2 months after completion of rhGM-CSF
Incidence of treatment-related adverse events
All treatment-related adverse events will be recorded
Time frame: 2 years
Incidence of immune-related adverse events
All Immune-related adverse events will be recorded
Time frame: 2 years
Total T cells count in peripheral blood
To assess the absolute number of T cells in per milliliter peripheral blood pre- and post-therapy.
Time frame: pre-treatment,1, 2, 3, 6, 12 months after completion of rhGM-CSF
Absolute number of CD4+T, CD8+T and regulatory T cells
To assess ratio of effector T cells: regulatory T cells in per milliliter peripheral blood pre- and post-therapy.
Time frame: pre-treatment,1, 2, 3, 6, 12 months after completion of rhGM-CSF
Plan to share: Yes — Data of tumor response, abscopal effect rate and survival time will be available within 4 months of study completion
This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Wuhan University