OncoMatch/Clinical Trials/NCT06403878
Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer
Is NCT06403878 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Carboplatin and Nab paclitaxel for esophageal cancer.
Treatment: Carboplatin · Nab paclitaxel · Sintilimab — We intend to conduct a prospective single-arm clinical study to explore the efficacy and safety of immunochemotherapy in neoadjuvant therapy in elderly patients with advanced esophageal squamous cell carcinoma. Most previous randomized controlled studies (such as the 5010 study) have excluded older patients ≥70 years of age. However, in the real world, elderly patients with esophageal cancer account for a large number of patients, and elderly people have many complications and poor tolerance to treatment, which limits the application of synchronous chemoradiotherapy in this group. There is no standard treatment plan for patients over 70 years old, and the purpose of this study is to explore the effectiveness and safety of neoadjuvant immunochemotherapy in the treatment of this group of elderly people.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage T2-4AN0M0, T1-4AN+M0 (AJCC eighth edition)
Clinical stage is T2-4aN0M0 or T1-4aN+M0, and MDT evaluation deems the patient operable (AJCC staging eighth edition).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Granulocyte count ≥1.5×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥80g/L
Kidney function
creatinine clearance rate ≥60 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤1.5×ULN, ALT or AST ≤2.5×ULN
Cardiac function
Normal ECG or abnormal ECG (deemed clinically insignificant by investigator); LVEF ≥50%
Hematological tests: Granulocyte count ≥1.5×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥80g/L. Biochemical tests: Total bilirubin ≤1.5×ULN, ALT or AST ≤2.5×ULN; creatinine clearance rate ≥60 mL/min (Cockcroft-Gault formula). Coagulation: INR or PT ≤1.5×ULN. Cardiac: Normal ECG or abnormal ECG (deemed clinically insignificant by investigator); LVEF ≥50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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