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Phase 2
Age: 18Years - 75Years
All Genders
ID06056336

Treatment Study of Tislelizumab and Chemotherapy Before and After Surgery in Patients with Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Led by Guo Xufeng · Updated on 2023-09-28

73

Participants Needed

1

Research Sites

117 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying patients with thoracic esophageal squamous cell carcinoma who receive neoadjuvant immunotherapy combined with chemotherapy followed by surgical removal of the tumor. The purpose is to assess whether adding further adjuvant therapy after surgery improves survival outcomes. This phase II study focuses on patients with specific clinical stages of esophageal cancer based on established cancer staging criteria. Eligible patients receive two cycles of neoadjuvant treatment with tislelizumab 200 mg every 3 weeks and chemotherapy drugs nad-paclitaxel and carboplatin. After surgery with complete tumor removal R0 resection, patients with no pathological residual cancer pCR receive tislelizumab for up to 30 weeks, while those without pCR receive two cycles of adjuvant immunotherapy plus chemotherapy followed by tislelizumab for 24 weeks. This approach evaluates the impact of additional therapy based on surgical response. Participants undergo regular assessments including imaging, pathological evaluation four weeks after surgery, and long-term follow-up for up to five years. Researchers monitor disease-free survival, overall survival, tumor response rates, surgical success, and adverse events. The main outcome is two-year disease-free survival among patients without complete response. Safety and effectiveness measures continue throughout the study and extended observation periods.

CONDITIONS

Brief Title

Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma

Research Team

X

Xufeng Guo, PH.D

X

Xufeng Guo, Ph.D

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