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/AClinical Study ID
NCT05323890
Shandong CHI
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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-relatedrocedures
- 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:
- 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 checkpointinhibitor
- Insufficient caloric and/or fluid intake despite consultation with a dietitian and/ortube 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 aspyelonephritis) before the first dose of trial treatment
- Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lungdysfunction
- 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
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
ChinaActive - Recruiting
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