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

Last updated: March 11, 2023
Sponsor: Shandong Cancer Hospital and Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Squamous Cell Carcinoma

Esophageal Disorders

Esophageal Cancer

Treatment

N/A

Clinical Study ID

NCT05323890
Shandong CHI
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-75
  2. Histologically or cytologically confirmed resectable squamous-cell esophageal cancer (cT1-2N+/ cT3-4aN0-3M0)
  3. Eastern Cooperative Oncology Group (ECOG) status 0-1
  4. Signed written informed consent prior to the implementation of any trial-relatedrocedures
  5. Adequate organ function, evidenced by laboratory results with no contraindications tochemotherapy Absolute neutrophil count ≥ 1,500 х109/l Thrombocytes ≥ 100 х 109/lHemoglobin ≥ 90 mg/l Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated usingthe Cockcroft-Gault formula) ≥40 mL/min Alanine aminotransferase (ALT) and aspartateaminotransferase (AST) > 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) > 5 x ULN Bilirubin > 1.5 х ULN

Exclusion

Exclusion Criteria:

  1. Patients diagnosed with any other malignant tumor
  2. Patients at risk for tracheoesophageal fistula or aortoesophageal fistula
  3. Have received prior therapy with: chemotherapy, radiation therapy,immune checkpointinhibitor
  4. Insufficient caloric and/or fluid intake despite consultation with a dietitian and/ortube feeding
  5. Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such aspyelonephritis) before the first dose of trial treatment
  6. Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lungdysfunction
  7. A history of interstitial lung disease or non-infectious pneumonia
  8. Active autoimmune disease with systemic therapy (ie, use of disease modifiers,corticosteroids, or immunosuppressive drugs) in the past 2 years
  9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
  10. Patients who have received allogeneic stem cell or solid organ transplantation
  11. Women during pregnancy or lactation

Study Design

Total Participants: 15
Study Start date:
April 20, 2022
Estimated Completion Date:
October 20, 2024

Connect with a study center

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong 250117
    China

    Active - Recruiting

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