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

Advanced Esophageal Squamous Cell Cancer Clinical Trial

Official title:

Neoadjuvant Tislelizumab Combined With Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma : Single Arm Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323890
• Other study ID #: Shandong CHI
• Status: Recruiting
• Phase: Phase 2
• Start date: April 20, 2022
• Est. completion date: October 20, 2024

Study information

• Verified date: March 2023
• Source: Shandong Cancer Hospital and Institute
• Contact: Xue Meng, Ph.D, M.D
• Phone: 17653115602
• Email: mengxuesdzl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 20, 2024
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?109/l Thrombocytes = 100 ? 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 ? ULN

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

Related Conditions & MeSH terms

• Advanced Esophageal Squamous Cell Cancer
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Neoplasms, Squamous Cell

Intervention

Drug:
• Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy
Patients received tislelizumab at a fixed dose of 200 mg every three weeks (q3w, 21 days) for 2 cycles.

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Pathological Response Rate	No more than 10% of tumor cells were found in neoadjuvant surgical specimens.	From date of surgery to 14 days later
Primary	Pathologic complete response rate	Pathologic complete response rate	From date of surgery to 14 days later
Secondary	Disease free survival	Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.	24 months
Secondary	Incidence of Treatment-related Adverse Events	Number and percentage of cases of all adverse events	8 weeks