IMMUNOTHERAPY Clinical Trial
Official title:
A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer
This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age 18-75 - Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC - Absence of EGFR, ALK, and ROS1 gene mutations - Eastern Cooperative Oncology Group (ECOG) status 0-1 - Signed written informed consent prior to the implementation of any trial-related rocedures - Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count = 1,500 ?109/L, Thrombocytes = 100 ? 109/L, Hemoglobin = 90 mg/L, Creatinine = 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) = 40 mL/min, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) > 5 x ULN, Bilirubin > 1.5 ? ULN Exclusion Criteria: - Patients diagnosed with any other malignant tumor - Have received prior therapy with chemotherapy or immune checkpoint inhibitor - Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding - Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment - Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction - A history of interstitial lung disease or non-infectious pneumonia - Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years - Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections - Patients who have received allogeneic stem cell or solid organ transplantation - Women during pregnancy or lactation |
Country | Name | City | State |
---|---|---|---|
China | Shandong Cancer Hospital and Institute | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong Cancer Hospital and Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Molecular imaging research and biomarker analysis | Plasma ctDNA testing, serum metabolomics testing, 18F-FDG uptake value, circulating immunological biomarkers, and observation of tumor immune microenvironment | 20 weeks | |
Primary | Major Pathological Response Rate | No more than 10% of tumor cells were found in neoadjuvant surgical specimens | From date of surgery to 14 days later | |
Primary | Pathologic complete response rate | No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes | From date of surgery to 14 days later | |
Secondary | Adverse events | Number and percentage of cases of all adverse events | 24 weeks | |
Secondary | Disease-free survival | The period of time from the initiation of treatment to the observation of disease progression or occurrence of death for any reason | 24 months |
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