Esophageal squamous cell carcinoma
Conditions
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18-75 years, gender is not limited; 3. The diagnosis of esophageal squamous cell carcinoma was confirmed by histopathological examination of the primary tumor biopsy; 4. Advanced esophageal squamous cell carcinoma diagnosed by histopathology and imaging examination; 5. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging; 6. Patients with brain metastases who are asymptomatic or whose symptoms are stable after local treatment are allowed to be enrolled. The patients must meet the following conditions: (1) There are measurable lesions outside the central nervous system; (2) No central nervous system symptoms or no exacerbation of symptoms within at least 2 months; (3) No need for glucocorticoid treatment or discontinuation of glucocorticoid treatment within 3 days before the first study drug administration; 7. ECOG score 0-1 points; 8. Expected survival time > 3 months; 9. Sufficient organ function, subjects should meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) is >= 1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets >= 100 x 10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin > 9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin = 60ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that the simple laboratory abnormality does not have clinical significance, it is also allowed to be included in the group); 10. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects (whether male or female) were required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1. It is known that there is a tendency to complete obstruction under endoscopy and requires interventional therapy to relieve the obstruction; 2. After esophagus or tracheal stent implantation; 3. Received systemic treatment for advanced or metastatic esophageal cancer in the past; 4. Patients with a high risk of bleeding or perforation due to the obvious invasion of the tumor into the adjacent organs (aorta or trachea) of the esophageal lesion, or patients with fistula formation; 5. Diagnosed with other malignant diseases other than esophageal cancer within 3 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 6. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 7. Received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs for another stimulation or synergistic inhibition of T cell receptors (eg, CTLA-4, OX-40, CD137); 8. Received radiation therapy for thoracic tumors in the past; 9. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration; 10. Active autoimmune disease requiring systemic therapy (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years prior to the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 11. Those who are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent) are allowed; 12. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 13. Those who are known to be allergic to the study drug sintilimab, platinum, paclitaxel, nab-paclitaxel, docetaxel, 5-Fu active ingredients or excipients; 14. Have not recovered sufficiently from toxicity and/or complications caused by any intervention (ie, <= Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment; 15. Known history of human immunodeficiency virus (HIV) infection (ie HIV1/2 antibody positive); 16. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the research center); Note: Hepatitis B patients who meet the following criteria can also be enrolled: (1) HBV viral load <200IU/ml before the first dose, patients should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation; (2) For patients with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, but viral reactivation needs to be closely monitored; 17. Active HCV infected patients (HCV antibody positive and HCV-RNA level above the detection limit); 18. Received li
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactHuang Bingjiang
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed