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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria: 1. Voluntary signing of informed consent; 2. Male or female, aged 18 years or above and 75 years or below; 3. Patients diagnosed with esophageal squamous cell carcinoma by biopsy histopathological examination of the primary lesion; cervical metastasis was excluded by cervical B-ultrasound. 4. 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. 5. Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 6. The ECOG performance status score is 0-1; 7. Have adequate heart, lung, liver and kidney functions, and the laboratory tests within 14 days before screening meet the following indicators: i. 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 8. Patients need to be able to complete the treatment and follow-up according to the research plan on schedule; 9. Patients need to have sufficient tissue samples and agree to use their tissue samples and blood samples for research analysis; 10. Pregnancy tests in women of childbearing age were negative and were willing to take effective contraceptive measures during the study. Exclusion Criteria: 1. Patients who may have tracheoesophageal fistula or aortic esophageal fistula; 2. Patients with severe malnutrition or in need of tube feeding; 3. 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); 4. 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; 5. 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; 6. 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; 7. Patients with uncontrollable systemic diabetes; 8. Patients with interstitial lung disease, non-infectious pneumonia or pulmonary fibrosis; 9. Patients with previous motor nerve or sensory nerve toxicity symptoms greater than WHO grade 1; 10. Patients who have received allogeneic organ or stem cell transplantation in the past; 11. Patients allergic to the drugs or related components involved in this study; 12. Patients currently participating in other clinical studies; 13. 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; 14. Patients with any serious or unstable medical conditions or mental illnesses; 15. Patients with known active alcohol or drug abuse or dependence.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pCR

Secondary Outcome Measures

Name	Time	Method
MPR;RFS;R0 resection rate;AEs

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