OncoMatch/Clinical Trials/NCT06190639
A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive ESCC
Is NCT06190639 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT06190639 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage T1-3N+M0 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages