OncoMatch/Clinical Trials/NCT04280822
Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma
Is NCT04280822 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Neoadjuvant immunochemotherapy for esophageal cancer.
Treatment: Neoadjuvant immunochemotherapy — The effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant immunochemotherapy Toripalimab (JS001) with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients versus neo-adjuvant chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage T1N1-3M0, T2-3N0-3M0 (8th Union for International Cancer Control, UICC-TNM)
Stage (T1N1-3 or T2-3N0-3 M0), (8th Union for International Cancer Control, UICC-TNM)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anticancer therapy
Patients must not have received any prior anticancer therapy of esophageal carcinoma.
Lab requirements
Blood counts
white blood cells count ≥4.0×10^9/L, neutrophil ≥1.5×10^9/L, platelets ≥100.0×10^9/L, hemoglobin ≥90g/L
Kidney function
normal functions of kidney, endogenous creatinine clearance rate(CRE)≤1.5N
Liver function
normal functions of liver, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N
Absolute white blood cells count ≥4.0×10^9/L, neutrophil ≥1.5×10^9/L, platelets ≥100.0×10^9/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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