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

NCT05323890 | Unknown Phase 2

• 1 other identifier: Shandong CHI
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Advanced Esophageal Squamous Cell Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Pathologic complete response rate

  Pathologic complete response rate

  From date of surgery to 14 days later

Secondary Outcomes (2)

• Disease free survival

  24 months

• Incidence of Treatment-related Adverse Events

  8 weeks

Study Arms (1)

Tislelizumab arm

EXPERIMENTAL

Radiotherapy: PTV 41.4Gy in 23 Fractions，5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg/m2) and Cisplatin (75 mg/m2) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks)

Drug: Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy

Interventions

Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy DRUG

Patients received tislelizumab at a fixed dose of 200 mg every three weeks (q3w, 21 days) for 2 cycles.

Also known as: Anti-PD-1 Therapy

Tislelizumab arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy; Drug Therapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Xue Meng, Ph.D, M.D

CONTACT

17653115602; mengxuesdzl@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, M.D

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: April 20, 2022
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CN (1)