Esophageal carcinoma, EC
Conditions
Interventions
Experimental group:chemotherapy+sintilimab+radiotherapy
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent prior to the implementation of any test related procedures; 2. Aged 18-75 years, gender is not limited; 3. Newly diagnosed subjects with stage IVB or recurrent metastatic esophageal cancer confirmed by histopathology and imaging examination, with measurable oligometastases 3 months; 9. Adequate organ function, subjects 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 =60ml/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. Subjects 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 female subjects of childbearing age, a urine or serum pregnancy test should be tested negative within 3 days prior to initial study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. It is known that endoscopic obstruction tends to be complete and requires interventional treatment to remove the obstruction; 2. After stent implantation in esophagus or trachea; 3. Previous systematic treatment for advanced or metastatic esophageal cancer; 4. Patients with high risk of bleeding or perforation due to tumor obvious invasion of the organs adjacent to the esophageal lesion (major artery or trachea), or patients with fistula; 5. Malignant diseases other than esophageal carcinoma diagnosed within 3 years prior to initial administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 6. Currently participating in an interventional clinical study, or receiving other investigational drugs or using investigational devices within 4 weeks prior to initial dosing; 7. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137); 8. Systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) was received within 2 weeks before the first administration; 9. An active autoimmune 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; 10. Being treated with systemic corticosteroids (excluding intranasal, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (<=10mg/ day of prednisone or equivalent) are permitted; 11. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. Those who are known to be allergic to the active ingredients or excipients of sindillimab, cisplatin and albumin-paclitaxel of the drug in this study; 13. Have 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); 14. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive); 15. Untreated active hepatitis B (defined as HBsAg positive coupled with a detected HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center); Note: Hepatitis B patients who meet the following criteria can also be enrolled: (1) HBV viral load <1000 copies /ml (200IU/ml) prior to initial dosing, patients should receive anti-HBV therapy to avoid viral reactivation throughout the study chemotherapeutic regimen; (2) For patients with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required; 16. Active HCV infected patients (HCV antibody positive and HCV-RNA level above the lower limit of detection); 17. The live vaccine was administered within 30 days prior to initial administration (cycle 1, day 1); Note: Inactivated injectable virus vaccine against seasonal influ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;objective remission rate;overall survival;safety index; | — |
Countries
China
Contacts
Public ContactWang Linlin
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed