Non-small Cell Lung Cancer Stage III
Conditions
Keywords
stage III locally advanced unresectable non-small-cell lung cancer, circulating tumor DNA, peripheral blood mononuclear cells
Brief summary
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.
Interventions
GENETICbiomarker detection
PBMC and ctDNA analysis
Sponsors
First People's Hospital of Hangzhou
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed, written and dated informed consent prior to any study specific procedures 2. Male or female aged over 18 years and under 70 years 3. Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to Version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology \[IASLC Staging Manual in Thoracic Oncology\]), and clinical evaluation is suitable for concurrent chemoradiotherapy or sequential chemoradiotherapy 4. With measurable lesions (according to RECIST 1.1 criteria, long diameter of tumor lesions is 10mm, short diameter of lymph node lesions is 15mm). 5. World Health Organization (WHO) Performance Status of 0\ 2 6. Life expectancy ≥6 months 7. 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 8. International standardized ratio of normal coagulation function, no active bleeding and thrombosis disease International standardized ratio INR≤1.5×ULN Partial thromboplastin time APTT≤1.5×ULN Prothrombin time Pt ≤1.5 UlN 9. For women of non-surgical sterilization or reproductive age, use of a medically approved contraceptive method (such as an intrauterine device, birth control pills, or condoms) during the study treatment period and within 3 months after the study treatment period; Women of reproductive age who are not surgically sterilized must be negative for serum or urine HCG within 7 days prior to study enrolment; And must be non-lactation; Male patients who are not surgically sterilized or of reproductive age need to agree to use a medically approved method of contraception with their spouse for the duration of the study treatment period and for three months after the end of the study treatment period 10. Patients volunteered to participate in this study with good compliance and cooperated with multiple blood sample collection and follow-up
Exclusion criteria
Patients should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers associated with immune efficacy | up to 2 years | 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 |
| Optimal time for immunotherapy | up to 2 years | Changes in the expression levels of ctDNA and PBMC immune cells before and after chemoradiotherapy to find the optimal time point for immunotherapy |
Countries
China
Contacts
Primary ContactShirong Zhang, Ph.D
Outcome results
None listed