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.
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Age ≥ 18 years, ≤ 75 years, both genders are eligible.
Patients with histologically confirmed clinical stage of locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM staging).
ECOG: 0-1.
Within the past six months, received EGFR monoclonal antibodies or EGFR-TKIs.
Participated in other interventional clinical trials within 30 days prior to screening.
Have severe comorbidities, such as heart failure, high-risk uncontrollable arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD stage 4 or higher), thyroid dysfunction, mental disorders, diabetes, severe chronic diarrhea (more than 7 bowel movements per day), etc., and those deemed unsuitable for this clinical study by the investigator.
Patients with brain metastases with symptoms or symptom control for less than 3 months.
Single group
HLX10
DrugSerplulimab 300mg d1, d22
Chemotherapy
DrugAlbumin-paclitaxel 175mg/m², carboplatin AUC = 4-5, d1, d22
Nimotuzumab
DrugNimotuzumab 400mg d1, qw, total of 5 cycles
MPR
Major Pathological response
pCR
Pathological complete regression rate
R0 resection rate
R0 resection rate
DFS
disease-free survival
EFS
event-free survival
LEFS
local event-free survival
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