Esophageal Squamous Cancer
Conditions
Interventions
Experimental group:Sindillimab in combination with chemotherapy
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent prior to implementing any trial-related procedures; 2. No gender limit, aged >=18 years; 3. Patients diagnosed with esophageal squamous cell carcinoma by primary biopsy histopathological examination; 4. Patients deemed operable and requiring neoadjuvant therapy by imaging and esophagoscopy (CT2-4, N1-3M0), stage II-IVA; 5. According to imaging and esophagoscopy, the main tumor of the patient was esophageal squamous cell carcinoma with a distance of >=5cm from the annular pharyngeal muscle in the cervical and thoracic segments; 6. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), at least one focal lesion can be observed on imaging; 7. The patient has not received any previous anti-tumor therapy, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 8. ECOG score 0-1; 9. Adequate organ function, patient shall meet the following laboratory criteria: (1) The absolute value of neutrophil granulocyte (ANC) >=1.5x10^9/L in the last 14 days without the use of granulocyte colony stimulating factor; (2) Platelets >=100x10^9/L without blood transfusion in the last 14 days; (3) Hemoglobin >9g/dL in the last 14 days without blood transfusion or erythropoietin use; (4) Total bilirubin =60 ml/min; (7) Good coagulation function, defined as International Standardized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; (8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range; Patients whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range; (9) The myocardial enzyme profile was within the normal range (if the researchers comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included); 10. For women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all patients (both men and women) are required to use a contraceptive with an annual failure rate of less than 1% throughout the treatment period up to 120 days after the last study drug (or 180 days after the last chemotherapeutic drug).
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other malignancies and not cured within 5 years prior to initial administration (excluding radical cutaneous basal cell carcinoma, cutaneous squamous epithelial carcinoma, and/or carcinoma in situ after radical excision); 2. Patients at risk of tracheoesophageal fistula or aortoesophageal fistula; 3. Currently participating in interventional clinical research and treatment; 4. An active autoimmune immune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 5. Be receiving systemic glucocorticoid therapy (excluding nasal, inhalation, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to initial administration; Note: Physiological doses of glucocorticoids (<=10 mg/ day of prednisone or equivalent) are permitted; 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Patients who are known to be allergic to the active ingredients or excipients of sindillizumab and combined chemotherapy; 8. Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., <= grade 1 or baseline, excluding weakness or hair loss); 9. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 10. Untreated active hepatitis B (defined as HBsAg positive coupled with a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the study center); 11. Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection); 12. Received live vaccine within 30 days prior to initial administration (cycle 1, day 1); Note: Inactivated injectable virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; But live attenuated influenza vaccines administered intranasally are not allowed. 13. Lactating patients; 14. The presence of any serious or uncontrolled systemic disease; 15. Medical history or evidence of disease that may interfere with test results, prevent participants from fully participating in the study, abnormal values of treatment or laboratory tests, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers other potential risks unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathologic response, MPR;relapse free survival, RFS;objective response rate, ORR;overall survival, OS; | — |
Countries
China
Contacts
Public ContactLin Shuang
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed