Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

Prior treatment

• Patients with immunodeficiency, or still receiving systemic steroid hormone therapy (prednisone \> 10 mg/day or other equivalent drugs) 7 days before the administration of the first dose of neoadjuvant therapy in this study, or other forms of immunosuppressive therapy;
• Patients with active infection and still in need of systemic treatment 7 days before the administration of the first dose of neoadjuvant therapy in this study;
• Patients with previous motor nerve or sensory nerve toxicity symptoms greater than WHO grade 1;
• Patients who have received allogeneic organ or stem cell transplantation in the past;
• Patients with known active alcohol or drug abuse or dependence.

Other illness

• Patients who may have tracheoesophageal fistula or aortic esophageal fistula;
• Patients with other malignant tumors within 2 years and not cured (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ);
• Patients with active autoimmune system diseases, or with a history of autoimmune system diseases or symptoms and in need of systemic hormone therapy or anti-autoimmune drug therapy;
• Patients with uncontrollable systemic diabetes;
• Patients with interstitial lung disease, non-infectious pneumonia or pulmonary fibrosis;
• Patients allergic to the drugs or related components involved in this study;
• Patients with any serious or unstable medical conditions or mental illnesses;

Lab values

• Patients who received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immune or molecular targeted therapies within 4 weeks before screening;

Other

• Patients with severe malnutrition or in need of tube feeding;
• Patients currently participating in other clinical studies;

• Voluntary signing of informed consent;
• Male or female, aged 18 years or above and 75 years or below;
• Patients diagnosed with esophageal squamous cell carcinoma by biopsy histopathological examination of the primary lesion; cervical metastasis was excluded by cervical B-ultrasound.
• Patients who were judged by imaging and endoscopic ultrasound examination to have potentially surgically resectable middle and lower esophagus (below 18 cm from the incisors) and require neoadjuvant therapy (T2-4aNxM0, stage II-IVA); for T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle.
• Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
• The ECOG performance status score is 0-1;
• Have adequate heart, lung, liver and kidney functions, and the laboratory tests within 14 days before screening meet the following indicators:
  • Hemoglobin HB ≥ 90 g/L ii. Absolute neutrophil count ANC ≥ 1.5 × 109 /L iii. Platelet count PLT ≥ 80 × 109 /L iv. Albumin ALB ≥ 35 g/L v. Alanine aminotransferase ALT and aspartate aminotransferase AST ≤ 1.5 times the upper limit of the normal range vi. Total bilirubin ≤ 30 μmol/L vii. Creatinine SCr ≤ the upper limit of the normal range. viii. Coagulation: PT-INR ≤ 2.3 or PT \< 6 seconds compared with the normal control
• Patients need to be able to complete the treatment and follow-up according to the research plan on schedule;
• Patients need to have sufficient tissue samples and agree to use their tissue samples and blood samples for research analysis;
• Pregnancy tests in women of childbearing age were negative and were willing to take effective contraceptive measures during the study.