esophagus cancer
Conditions
Interventions
experimental group:sintilimab in combination with paclitaxel and cisplatin neoadjuvant therapy
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent prior to the implementation of any test related procedures; 2. Aged 18-75 years; 3. Histopathological examination confirmed resectable esophageal carcinoma (histologically, squamous cell carcinoma), without esophageal/gastric junction adenocarcinoma; 4. Before surgery, CT/MRI, color ultrasound, PET-CT, and ultrasonic gastroscopy were used to clearly diagnose esophageal cancer staging as >= CT3 or >=N+; 5. Newly diagnosed patients without previous surgery, radiotherapy or chemotherapy, targeted therapy or immunotherapy; 6. ECOG score 0-2; 7. No serious heart, lung or liver dysfunction; No acute infection was associated; 8. No participation in other clinical studies within 3 months prior to treatment; 9. Sufficient organ function, subject should meet the following laboratory criteria: 1) The absolute value of neutrophils (ANC) >=1.5x10^9/L in the last 14 days without the use of granulocyte colony-stimulating factor; 2) Platelets >=100x10^9/L in the case of no blood transfusion in the last 14 days; 3) Hemoglobin >10g/dL in the absence of blood transfusion or use of erythropoietin in the last 14 days; 4) Total bilirubin ULN but direct bilirubin =60ml/min; 7) Good coagulation function, defined as INR or prothrombin time (PT) <=1.5 ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is beyond the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can be included; 9) Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judged that it is a simple laboratory abnormality without clinical significance, it is also allowed to be enrolled); 10. For female subjects 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 (cycle 1 day 1). If a urine pregnancy test cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age were defined as at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (both men and women) should use contraceptives with an annual failure rate of less than 1% throughout the treatment period and up to 180 days after the last study dosing.
Exclusion criteria
Exclusion criteria: 1. Previous operation history of thoracic malignant tumor; 2. Pathologically small cell carcinoma or distant metastasis; Patients with tumor involvement of the cervical esophagus or high upper thoracic segment requiring laryngectomy; 3. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg); 4. Patients at high risk of bleeding or perforation due to tumor invasion of an adjacent organ of the esophageal lesion (aorta or trachea), or patients with fistula; 5. Other malignant diseases other than esophageal cancer diagnosed within 5 years prior to initial administration (excluding basal cell carcinoma of the skin after radical resection, squamous carcinoma of the skin, and/or carcinoma in situ after radical resection); 6. Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 7. Received Chinese patent drugs with anti-tumor indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for local use of pleural effusion control) within 2 weeks before the first administration; 8. Known interstitial pulmonary disease requiring steroid therapy, active pulmonary tuberculosis, active autoimmune disease requiring systemic therapy (e.g., use of palliative drugs, glucocorticoids, or immunosuppressants) developed within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 9. The study was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days prior to initial administration; Note: Physiological dose of glucocorticoids (<=10mg/ day of prednisone or equivalent drug) is allowed; 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. People who are known to be allergic to the active ingredients or exciphers of the drugs in this study, such as cisplatin, cisplatin, or albu-paclitaxel; 12. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive); 13. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center); Note: HBV subjects who meet the following criteria can also be enrolled: 1) HBV viral load <1000 copies/mL (200IU/ mL) before first administration, and subjects should receive anti-HBV therapy throughout the study chemotherapeutic drug therapy to avoid viral reactivation; 2) For subjects resistant to HbC (+), HBsAg (-), anti-HbS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required; 14. Active HCV infected subjects (HCV antibody positive and HCV-RNA levels above the detection limit); 15. Have received live vaccine within 30 days before the first administration (cycle 1, day 1); Note: Inactivated virus vaccine for injection against seasonal influenza is allowed up to 30 days prior to the first administration; However, live attenuated influenza vaccines administered i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response;Objective response rate;Perioperative mortality;Treatment related AES; | — |
Countries
China
Contacts
Public ContactKang Mingqiang, Lin Jiangbo
Fujian Union Hospital
Outcome results
None listed