OncoMatch/Clinical Trials/NCT06006650
Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell
Is NCT06006650 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin for neoadjuvent.
Treatment: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin — The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage II, III, IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy
no prior antitumor therapy, such as immunotherapy or chemoradiotherapy
Cannot have received: chemoradiotherapy
no prior antitumor therapy, such as immunotherapy or chemoradiotherapy
Cannot have received: anti-PD-1 therapy
Previously treated with anti-PD-1 or anti-PD-L1 antibodies
Cannot have received: anti-PD-L1 therapy
Previously treated with anti-PD-1 or anti-PD-L1 antibodies
Cannot have received: investigational drug
Receiving any investigational drug within 4 weeks before the first use of the investigational drug
Cannot have received: anti-tumor vaccine
People who have been vaccinated with anti-tumor vaccine or who have been vaccinated with live vaccine within 4 weeks prior to the first administration of the study drug
Cannot have received: live vaccine
People who have been vaccinated with anti-tumor vaccine or who have been vaccinated with live vaccine within 4 weeks prior to the first administration of the study drug
Lab requirements
Blood counts
Hemoglobin ≥100g/L, white blood cell count ≥4*10^9/L or neutrophil count ≥2.5*10^9/L, platelet count ≥100*10^9/L
Kidney function
serum creatinine level below the upper limit of normal or creatinine clearance rate ≥60ml/min, urea nitrogen ≤200mg/L, urinary protein <+, if urinary protein +, 24-hour total protein must be <500mg
Liver function
serum total bilirubin level ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal, Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal
Cardiac function
no myocardial infarction within 1 year; Unstable angina pectoris; Asymptomatic severe arrhythmias; The centerless function is incomplete
Organs function well: Hemoglobin ≥100g/L, white blood cell count ≥4*10^9/L or neutrophil count ≥2.5*10^9/L, platelet count ≥100*10^9/L, serum total bilirubin level ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal, Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, serum creatinine level below the upper limit of normal or creatinine clearance rate ≥60ml/min, urea nitrogen ≤200mg/L, urinary protein <+, if urinary protein +, 24-hour total protein must be <500mg, blood glucose: In patients with normal-range and/or diabetes under treatment but stable glycemic control, pulmonary function: baseline FEV1 of at least 2L; If the baseline FEV1 was <2L, the predicted FEV1 after surgery was >800ml, and the cardiac function was: no myocardial infarction within 1 year; Unstable angina pectoris; Asymptomatic severe arrhythmias; The centerless function is incomplete
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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