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Spots Global Cancer Trial Database for Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma

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Trial Identification

Brief Title: Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma

Official Title: Perioperative Immunoagent (Tislelizumab) Plus Chemotherapy for Locally Advanced Resectable Thoracic Oesophageal Squamous Cell Carcinoma Trail:A Prospective Single-arm,Phase II Study (PILOT Trail)

Study ID: NCT06056336

Interventions

Tislelizumab

Study Description

Brief Summary: The purpose of this study is to analyze esophageal cancer patients who underwent neoadjuvant immunotherapy with chemotherapy followed by esophagectomy to determine whether additional adjuvant therapy is associated with improved survival outcomes.

Detailed Description: Eligiled patients with pathologically confirmed thoracic esophageal squamous cell carcinoma and at clinical T1b-3N1-3M0 or T3N0M0 according to the eighth edition of American Joint Committee on Cancer staging will be allocated to neoadjuvant immunotherapy (tislelizumab 200mg d1, q3w × 2 cycles ) and chemotherapy (nad-paclitaxel 260 mg/m2 d1 + carboplatin AUC = 5 d1, q3w × 2 cycles) treatment. Patients with resected (R0) were assigned to receive tislelizumab ( at a dose of 200 mg every 3 weeks for 30 weeks) in pCR patients or adjuvant immunotherapy and chemothearpy for two cycles, and then tislelizumab ( at a dose of 200 mg every 3 weeks for 24 weeks) in non-pCR patients.The primary endpoint for this study is 2-year disease-free survival (DFS) in non-pCR patients.The secondary endpoints include pCR rate, major pathological response (MPR) rate, 2-year DFS in pCR patients, R0 resection rate, adverse events, and overall survival (OS).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Shanghai chest hospital, Shanghai, Shanghai, China

Contact Details

Name: Changqing Pan

Affiliation: the International Committee of Medical Journal Editors

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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