An observational study in Non-small Cell Lung Cancer Stage III, sponsored by First People's Hospital of Hangzhou. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by First People's Hospital of Hangzhou · Observational
This study aims to dynamically monitor the expression profile status of peripheral blood mononuclear cells (PBMC) and the changes in circulating tumor DNA (ctDNA) levels in patients with stage III locally advanced unresectable non-small-cell lung cancer(NSCLC) after concurrent chemoradiotherapy or sequential chemoradiotherapy, and to explore biomarkers related to the immune microenvironment and the optimal time point for immunotherapy after chemoradiotherapy.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 50 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →First People's Hospital of Hangzhou is the lead sponsor of 70 studies on the registry; 26 are open to participants now.
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Patients with Stage III locally advanced unresectable Non-small cell lung cancer (NSCLC)
Adequate organ and marrow function as defined below:
Absolute neutrophil count >1.5 x 109/L (1500 per mm3) Platelets >90 x 109/L (90,000 per mm3) Haemoglobin ≥9.0 g/dL (5.59 mmol/L) Serum creatinine CL >50 mL/min by the Cockcroft-Gault formula Serum bilirubin ≤1.5 x upper limit of normal (ULN) Total bilirubin (TBIL) ≤ 1.5 x upper limit of normal (ULN) In patients with no liver metastasis: AST and ALT ≤2.5 x ULN In patients with liver metastasis: AST or ALT ≤5 x ULN Urinary protein \<2+; If the urine protein is ≥2+, the 24-hour urine protein quantification must show the protein to be ≤1g
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
Genetic: biomarker detection
PBMC and ctDNA analysis
Biomarkers associated with immune efficacy
According to the biomarker detection before and after chemoradiotherapy to identify biomarkers related to the immune microenvironment, including the expression levels of NK cells, T cells, B cells and other immune cells reflected by PBMC, as well as the expression levels of ctDNA
Time frame: up to 2 years
Optimal time for immunotherapy
Changes in the expression levels of ctDNA and PBMC immune cells before and after chemoradiotherapy to find the optimal time point for immunotherapy
Time frame: up to 2 years
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Hangzhou