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RECRUITING
NCT07457528
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2026-03-12

Completion Date

2027-06-30

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

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

Locations (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China