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Pembrolizumab Plus CRT Followed by Surgery in Upper ESCC

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
A Prospective, Single-arm Phase Ib/II Study to Explore the Safety and Efficacy of Pembrolizumab Combined With Neoadjuvant Chemoradiotherapy (CRT) Followed by Surgery for Upper Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

Clinical Trial Summary

Through a prospective, single-center, single-arm, phase Ib/II study, we aim to explore the safety and feasibility of a new treatment mode for upper esophageal cancer, which is that pembrolizumab combined with chemoradiotherapy as neoadjuvant therapy and then followed by radical surgery.

Clinical Trial Description

Treatment includes induction treatment, sequential treatment and maintenance treatment. 1. Preoperative neoadjuvant therapy 1) Induction therapy (2 cycles): Immunotherapy+Chemotherapy Pembrolizumab 200mg, IV, D1, q3w, Albumin paclitaxel, 125mg/m2, IV, D1/D8, q3w; Cisplatin, 70mg/m2 in total, IV, given in three times, q3w. 2) Sequential treatment: Immunotherapy+Chemoradiotherapy Pembrolizumab 200mg, IV, D1, q3w, 2 cycles; Albumin paclitaxel, 100mg, IV, D1, QW, 4 cycles; Cisplatin, 20mg/m2, IV, D1, QW, 4 cycles. Radiotherapy: PTV: 44gy/2gy/22fx, 5 days a week, 5 weeks in total. 2. Surgery 4-8 weeks after the end of the neoadjuvant therapy, the operation can be performed only when the indexes of leukocyte, platelet, liver and kidney function of the patient are normal. The operation aims to achieve R0 resection with laryngeal preservation. 3. Postoperative adjuvant treatment Patients who did not reach pCR after operation were given pembrolizumab 200mg, IV, D1, q3w 4-6 weeks after operation until 1 year, disease progression or intolerable toxicity. 4. Follow-up period Patients will be continuously monitored during the study. The enrolled subjects will be closely followed up for 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05541445
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Yong Li, MD
Phone +8613831120879
Email liyongdoctor@126.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 1, 2022
Completion date December 1, 2024
View Details
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