Cervical Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Radical radiochemotherapy or surgery
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who sign the informed consent form and are willing to complete the study according to the protocol; 2. The lesion site is limited to the cervical segment or the midpoint of the lesion is located in the cervical segment; 3. Pathological biopsy results showed esophageal squamous cell carcinoma; 4. Aged 18 to 75 years; 5. ECOG score: 0-1 points; 6. No metastasis to distant organs such as lung, liver, pelvis and peritoneum; 7. Patients with resectable cervical esophageal cancer (T1b-T4aNanyM0) evaluated by CT and endoscopic ultrasonography before surgery; 8. Normal function of major organs, including: (1) Routine blood examination (no blood components, cell growth factors, whitening drugs, platelet increasing drugs, and anemia correction drugs are not allowed to be used within 14 days before the first use of the study drug): 1) White blood cell count >= 4.0x10^9/L; 2) Neutrophil count >= 1.5x10^9/L; 3) Platelet count >= 100x10^9/L; 4) Hemoglobin >= 90 g/L. (2) Blood biochemical examination: 1) Total bilirubin = 50 mL/min (Cocheroft-Gault formula). (3) Coagulation function: 1) International Normalized Ratio (INR) <= 1.5xULN; 2) Activated partial thromboplastin time (APTT) <= 1.5xULN. (4) Blood sugar: within the normal range and/or patients with diabetes are under treatment but the blood sugar is controlled in a stable state. 9. Female subjects with fertile potential should undergo a serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraception during the trial and at least 3 months after the last dose Measures (such as intrauterine devices, contraceptives or condoms); for male subjects whose partners are females of childbearing age, effective contraceptive measures should be taken during the trial and within 3 months after the last dose; 10. The subjects have good compliance and can follow up the efficacy and adverse events/reactions according to the requirements of the program.
Exclusion criteria
Exclusion criteria: 1. There are unresectable factors, including tumor invading the trachea or large blood vessels, or those who have surgical contraindications and are unresectable or refuse surgery; 2. Poor nutritional status, BMI 10mg/day prednisone or equivalent dose); in the absence of active autoimmunity In case of disease, inhaled or topical steroids and adrenal corticosteroid replacement at doses >10 mg/day prednisone or equivalent are permitted; (3) Received live attenuated vaccine within 4 weeks before the first use of the study drug; (4) Major surgery or serious trauma within 4 weeks before the first use of the study drug; 5. Have a history of immunodeficiency, including HIV positive test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation; 6. There are clinical symptoms or diseases of the heart that are not well controlled, including but not limited to: such as (1) NYHA class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are still poorly controlled without clinical intervention or after clinical intervention. 7. Serious infection (CTCAE 5.0 > grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization; baseline chest imaging examinations suggest the presence of active lung Inflammation, symptoms and signs of infection within 14 days before the first use of the study drug, or requiring oral or intravenous antibiotic treatment, except for the case of intravenous prophylactic antibiotics administered within 48 hours; 8. Medications/treatments used in other clinical studies within 4 weeks before randomization; 9. Those who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or have other pulmonary fibrosis that may interfere with the judgment and management of immune-related pulmonary toxicity , Organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with active pneumonia or severe pulmonary function impairment on CT at screening; active pulmonary tuberculosis; 10. Patients with any active autoimmune disease or history of autoimmune disease and possible recurrence [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis , nephritis, hyperthyroidism, hypothyroidism (patients that can be controlled by hormone replacement therapy alone can be enrolled)]; patients with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, insulin Patients with treatment-controlled type 1 diabetes or a history of asthma who have been in complete remission in childhood without any intervention can be enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;disease-free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;recurrence-free survival;appraisal of life quality; | — |
Countries
China
Contacts
Public ContactLi Zhigang
Shanghai Chest Hospital
Outcome results
None listed