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Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer

Recruiting
18 years of age
Both
Phase N/A

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Overview

This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.

Eligibility

Inclusion Criteria:

        Age at least 18 years. ECOG PS 0-1. Pathologically confirmed NSCLC, esophageal squamous
        cell carcinoma or thymic epithelial tumor.
        Life expectancy of more than 3 months. Patients with no indications for palliative
        radiotherapy in the opinion of the investigator.
        Patients with a prior history of surgery are eligible if they have recovered adequately
        from the toxicity and/or complications of surgery.
        Signed informed consent for the use of fresh tumor biopsies before and during the
        treatment.
        Women of childbearing age and men must agree to use effective contraception during the
        trial.
        Adequate organ function within 1 week prior to the enrollment:
          1. Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 *
             10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, and platelet count ≥ 100 * 10 ^ 9/L;
          2. Adequate hepatic function: total bilirubin < 1.5 x upper limit of normal (ULN). Note:
             If total bilirubin is > 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate
             aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
          3. Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50
             mL/min;
        Exclusion Criteria:
        Pregnant or lactating women. History of any other malignancy. Patients in whom palliative
        radiotherapy is indicated in the opinion of the investigator.
        Active infection, congestive heart failure, myocardial infarction within the 6 months prior
        to enrollment, unstable angina pectoris or cardiac arrhythmia.
        Patients who have received tumor vaccine; or administration of live, attenuated vaccine
        within 4 weeks before the start of treatment.
        Mental disorders, drug abuse, and social condition that may negatively impact compliance in
        the opinion of the investigator.

Study details

NSCLC, Esophageal Squamous Cell Carcinoma, Thymic Epithelial Tumor

NCT04522687

Shanghai Cancer Hospital, China

25 January 2024

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