OncoMatch/Clinical Trials/NCT07457528
Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC
Is NCT07457528 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including HLX10 and Chemotherapy for resectable esophageal squamous cell carcinoma.
Treatment: HLX10 · Chemotherapy · Nimotuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage CT1N2-3M0, CT2-4AN0-3M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR monoclonal antibody
Exception: within the past six months
Within the past six months, received EGFR monoclonal antibodies or EGFR-TKIs.
Cannot have received: EGFR tyrosine kinase inhibitor
Exception: within the past six months
Within the past six months, received EGFR monoclonal antibodies or EGFR-TKIs.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5×10^9, platelets ≥ 80×10^9, hemoglobin ≥ 90g/L
Kidney function
Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula)
Liver function
Total bilirubin level ≤ 1.5 times ULN, AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN with liver metastasis)
Cardiac function
LVEF ≥ lower limit of normal (50%) by Doppler ultrasound
Important organ functions meet the following requirements: 1. Absolute neutrophil count ≥ 1.5×10^9, platelets ≥ 80×10^9, hemoglobin ≥ 90g/L; 2. Total bilirubin level ≤ 1.5 times ULN, AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN with liver metastasis); 3. Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula); 4. Serum albumin ≥ 28g/L; 5. LVEF ≥ lower limit of normal (50%) by Doppler ultrasound; 6. Pulmonary function: FEV1/FVC ≥ 70%, FEV1 ≥ 50% of normal value, DLCO > 80% predicted.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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