Actively Recruiting
Study Comparing Pembrolizumab with Chemotherapy as Pre-Surgery Treatment for Stage II-IVa Esophageal Squamous Cell Carcinoma
Led by Tang-Du Hospital · Updated on 2023-08-23
114
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of pembrolizumab combined with albumin paclitaxel and cisplatin compared to chemotherapy alone using albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin. The study focuses on patients with stage II-IVa resectable esophageal squamous cell carcinoma, aiming to improve neoadjuvant therapy outcomes. This is a phase 2 randomized controlled trial planned to enroll 114 patients. Participants are randomly assigned into three groups receiving either pembrolizumab plus albumin paclitaxel and cisplatin, pembrolizumab plus 5-fluorouracil and cisplatin, or chemotherapy alone with 5-fluorouracil and cisplatin. Each group receives three cycles of neoadjuvant therapy followed by surgery after three weeks. After surgery, patients undergo 16 cycles of pembrolizumab as adjuvant immunotherapy. Throughout the study, patients are monitored for treatment efficacy and safety. Tumor evaluations occur at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until disease progression. Outcomes measured include pathologic complete response rate, major pathological response, event-free survival, and overall survival. Safety is assessed by recording adverse reactions and perioperative complications. The total follow-up extends up to 10 years for survival outcomes.
CONDITIONS
Brief Title
Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell
Research Team
X
Xiaolong Yan, MD
H
HongTao Duan, MD
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