OncoMatch/Clinical Trials/NCT06190639
A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive ESCC
Is NCT06190639 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies sintilimab for esophageal squamous cell carcinoma.
Treatment: sintilimab — The goal of this clinical trial is to evaluate the efficacy and safety of sintilimab as adjuvant therapy in node-positive esophageal squamous cell carcinoma after radical surgery without neoadjuvant therapy. The main question it aims to answer is: • Efficacy of sintilimab as adjuvant therapy Participants will receive sintilimab 200 mg once on day 1, every 21 days(Q3W).
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage T1-3N+M0 (AJCC 8th)
Histologically confirmed T1-3N+M0 thoracic esophageal squamous cell cancer (AJCC 8th)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Complete resection followed by treatment for the removed esophageal cancer (e.g., chemotherapy, targeted drugs, radiation, or biotherapy)
Cannot have received: targeted therapy
Complete resection followed by treatment for the removed esophageal cancer (e.g., chemotherapy, targeted drugs, radiation, or biotherapy)
Cannot have received: radiation therapy
Complete resection followed by treatment for the removed esophageal cancer (e.g., chemotherapy, targeted drugs, radiation, or biotherapy)
Cannot have received: biotherapy
Complete resection followed by treatment for the removed esophageal cancer (e.g., chemotherapy, targeted drugs, radiation, or biotherapy)
Cannot have received: immunotherapy
Radiotherapy, chemotherapy, immunotherapy, esophagectomy, esophagus-gastric junction, and gastric surgery were performed before the trial.
Lab requirements
Blood counts
WBC ≥2000/μL; Neutrophils ≥1500/μL; Platelets ≥100 x 10^3/μL; Hemoglobin ≥9.0 g/dL
Kidney function
Serum creatinine ≤1.5 x ULN or creatinine removal rate > 50mL/min (Cockcroft/Gault formula)
Liver function
AST ≤3 x ULN; ALT ≤3 x ULN; Total bilirubin ≤1.5 x ULN (except for subjects with Gilbert syndrome, where total bilirubin must be < 3 x ULN)
Laboratory test values must be selected according to the following criteria (CTCAE V5.0): 1. WBC ≥2000/μL; 2. Neutrophils ≥1500/μL; 3. Platelets ≥100 x 103/μL; 4. Hemoglobin ≥9.0 g/dL; 5. Creatinine: Serum creatinine ≤1.5 x above normal (ULN) or creatinine removal rate > 50mL/ min (Cockcroft/Gault formula); 6. AST ≤3 x ULN; 7. ALT ≤3 x ULN; 8. Total bilirubin ≤1.5 x ULN (except for subjects with Gilbert syndrome, where total bilirubin must be < 3 x ULN);
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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