Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.

  • STATUS
    Recruiting
  • End date
    Oct 20, 2024
  • participants needed
    15
  • sponsor
    Shandong Cancer Hospital and Institute
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Updated on 26 April 2022
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Summary

This study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. The tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting the efficacy of neoadjuvant therapy for esophageal cancer. This study will provide valuable information for further prospective clinical trials of neoadjuvant anti-PD-1 and other immunotherapy in esophageal cancer patients.

Details
Condition Advanced Esophageal Squamous Cell Cancer
Treatment Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy
Clinical Study IdentifierNCT05323890
SponsorShandong Cancer Hospital and Institute
Last Modified on26 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18-75
Histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( cT1-2N+/ cT3-4aN0-3M0)
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 х109/l Thrombocytes ≥ 100 х 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 х ULN

Exclusion Criteria

Patients diagnosed with any other malignant tumor
Patients at risk for tracheoesophageal fistula or aortoesophageal fistula
Have received prior therapy with: chemotherapy, radiation therapy,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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