Clinical Trial

Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell

Recruiting Phase 2
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Summary
The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
Trial Details
NCT Number NCT06006650
Lead Sponsor Tang-Du Hospital
Conditions Neoadjuvent, PD-1 Inhibitor, Chemotherapy, Esophageal Squamous Cell Carcinoma
Enrollment 114 participants
Start Date 2022-08-01
Primary Completion 2031-12-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-08-23