Status:
UNKNOWN
Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Advanced Esophageal Squamous Cell Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 microenvironm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05323890
Start Date
April 20 2022
End Date
October 20 2024
Last Update
March 14 2023
Active Locations (1)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117