NCT07457528

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

Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Resectable Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	HLX10	Serplulimab 300mg d1, d22
DRUG	Chemotherapy	Albumin-paclitaxel 175mg/m², carboplatin AUC = 4-5, d1, d22
DRUG	Nimotuzumab	Nimotuzumab 400mg d1, qw, total of 5 cycles

Timeline

• Start date: 2026-03-12
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2026-03-09
• Last updated: 2026-03-11

Locations

1 site across 1 country: China