PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Inclusion criteria

• Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
• Patients must not have received any prior anticancer therapy.
• More than 6 months of expected survival.
• Age ranges from 18 to 70 years.
• Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
• WHO PS score 0-1
• Signed informed consent document on file.

Exclusion criteria

• Patients have received any prior anticancer therapy.
• Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
• Patients with concomitant hemorrhagic disease.
• Patients who cannot tolerate surgery.
• Pregnant or breast feeding.
• Patients without informed consent because of psychological, family, social or any other factors.
• Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
• Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
• Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
• Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
• Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
• Patients with history of interstitial lung disease or noninfectious pneumonia.
• Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
• Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).