drugset / Trial / NCT07457528

Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC

NCT07457528

NaSingle-groupOpen-labelTreatment

Summary

This trial is conducted in patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 46 patients with resectable locally advanced esophageal cancer in Tianjin cancer hospital. Patients will be treated with serplulimab, nimotuzumab plus concurrent chemoradiotherapy (41.4Gy/1.8Gy/23F) . Six to eight weeks after the completion of neoadjuvant chemoradiotherapy, patients who are considered operable by surgeons will undergo radical resection of esophageal cancer. Postoperative pathological assessment includes MPR rate, pCR rate, and pathological response grade, etc. This trial aims to explore the safety and efficacy of adding serplulimab and nimotuzumab to neoadjuvant chemoradiotherapy, with a focus on whether the combined treatment regimen can enhance the efficacy and safety of neoadjuvant chemoradiotherapy.

Timeline

Start
2026-03-12
Primary completion
2027-06-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 400 mg
Subject Serplulimab Monoclonal antibody 300 mg
Background Carboplatin Small molecule
Background Paclitaxel Small molecule 175 mg/m2