NCT05541445

Pembrolizumab Plus CRT Followed by Surgery in Upper ESCC

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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	The subjects first receive induction therapy with pembrolizumab combined with chemotherapy for 6 weeks, and then receive sequential therapy with pembrolizumab combined with concurrent chemoradiotherapy for 6 weeks, and receive surgical treatment within 4-8 weeks after neoadjuvant therapy. For patients whose postoperative pathology is confirmed as PCR (pathological complete response), the patients will be observed with long-time follow-up; If the postoperative pathology is confirmed as non-PCR, pembrolizumab will be administrated until 1 year or disease progression or intolerable toxicity.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2022-09-15
• Last updated: 2022-09-15

Locations

1 site across 1 country: China