NCT05828381

Envafolimab Combined With Abraxane and Cisplatinas as Neoadjuvant Treatment for Resectable Esophageal Cancer

A Prospective, Single-arm Multicenter Clinical Trial of Envafolimab Combined With Abraxane and Cisplatinas in Resectable Esophageal Squamous Cell Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Big breakthroughs have been made in the combination therapy of immune checkpoint inhibitors when it comes to the neoadjuvant therapy of esophageal cancer. Several studies, such as Cross, have shown that although preoperative adjuvant chemoradiotherapy could improve the local control rate of lesions, the incidence of distant metastasis still remains high in the long term. Compared with preoperative adjuvant chemoradiotherapy, the treatment of combination with immunotherapy has shown a lot of advantages such as shorter hospital stay, fewer complications and lower cost, which may replace preoperative chemotherapy or chemoradiotherapy for esophageal cancer as a new treatment .This is a single-arm, exploratory phase II clinical study to evaluate the efficacy and safety of Envafolimab combination with Abraxane and cisplatin as preoperative neoadjuvant therapy for patients with resectable esophageal squamous cell carcer. In the study, all subjects meeting enrollment criteria will receive 2 cycles of neoadjuvant therapy with Envafolimab combined with Abraxane and cisplatin as scheduled. Around 4-6 weeks after the last neoadjuvant therapy, they will receive radical surgery. Evaluation will be conducted after the completion of the surgical cycle to determine the pathological complete response rate , R0 resection rate and major pathological response rate of these treated patients. The objective is To evaluate the efficacy and safety of Enbrelizumab in combination with Abraxane and cisplatin for preoperative neoadjuvant therapy in patients with resectable esophageal squamous cancer.

Conditions

• Immunotherapy;Envafolimab; Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Envafolimab	300mg,sc,d1,q3w; for a total of 2 cycles.
DRUG	Abraxane	100mg/m2,ivgtt, D1、D8,q3w ,for a total of 2 cycles
DRUG	Cisplatin	75 mg/m2 vigtt D1 , q3w , for a total of 2 cycles

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-04-25
• Last updated: 2023-04-25