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Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC

RecruitingPhase 2Ages 18 Years - 75 YearsAllShandong Cancer Hospital and Institute
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In plain words

What the trial is, and whether it could suit you

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 second

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 1,500 ั…109/L, Thrombocytes โ‰ฅ 100 ั… 109/L, Hemoglobin โ‰ฅ 90 mg/L, Creatinine โ‰ค 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) โ‰ฅ 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
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What it tests

  • Camrelizumab Plus Chemotherapy
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Where

1 site
Shandong Cancer Hospital and Institute
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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