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

Sponsored by Shandong Cancer Hospital and Institute

About this trial

Last updated 2 years ago

Study ID

Shandong CHI

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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-related rocedures

5. 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

No

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 checkpoint inhibitor

4. Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube 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 as pyelonephritis) before the first dose of trial treatment

6. Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction

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

Locations

Location

Status

Recruiting