A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive Esophageal Squamous Cell Carcinoma After Radical Surgery Without Neoadjuvant Therapy
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).
• Signed an Informed Consent Form
• Participant type and target disease characteristics:
‣ ECOG PS 0-1
⁃ Histologically confirmed T1-3N+M0 thoracic esophageal squamous cell cancer (AJCC 8th)
⁃ can tolerate radical resection of esophageal cancer
⁃ Resection must be performed within 4-12 weeks prior to enrollment
⁃ All participants must be confirmed disease-free by physical and imaging examinations within 4 weeks prior to enrollment. Imaging examinations must include CT/MRI scans of the neck, chest and abdomen.
⁃ All baseline laboratory tests will be evaluated as required and results should be available within 28 days prior to enrollment. Laboratory test values must be selected according to the following criteria (CTCAE V5.0):
• WBC ≥2000/μL;
∙ Neutrophils ≥1500/μL;
∙ Platelets ≥100 x 103/μL;
∙ Hemoglobin ≥9.0 g/dL;
∙ Creatinine: Serum creatinine ≤1.5 x above normal (ULN) or creatinine removal rate \> 50mL/ min (Cockcroft/Gault formula);
∙ 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);
• Age and fertility status:
‣ Age ≥18 years old
⁃ Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity of HCG is 25 IU/L or equivalent) within 24 hours before starting study treatment.
⁃ Women must be non-breastfeeding