Cervical esophageal carcinoma
Conditions
Interventions
Group 1:Radical radiochemotherapy
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who sign informed consent and are willing to complete the study according to the plan; 2. The lesion site was confined to the neck segment or the lesion midpoint was located in the neck segment; 3. Pathological biopsy results showed esophageal squamous cell carcinoma; 4. Aged 18-75 years; 5. ECOG score: 0-1; 6. No lung, liver, pelvic cavity, peritoneum and other distant organ metastasis; 7. Preoperative CT and endoscopic ultrasonography evaluated the patient as a resectable cervical esophageal carcinoma (T2-T4aNanyM0); 8. Normal function of major organs, including: (1) Routine blood examination (no blood components, cell growth factors, elevated white drugs, elevated platelet drugs, anemia correction drugs are allowed within 14 days before the first use of the study drug) : white blood cell count >= 4.0x10^9/L; Neutrophil count >= 1.5x10^9/L; Platelet count >= 100x10^9/L; Hemoglobin >= 90 g/L; (2) Blood biochemical examination: total bilirubin = 50 mL/min (Cocheroft-Gault formula); (3) Coagulation function: International Standardized ratio (INR) <= 1.5xULN; Activated partial thrombin time (APTT) <= 1.5xULN; (4) Blood glucose: within the normal range and/or in patients with diabetes under treatment but under stable blood glucose control; 9. Fertile female patients are required to take a negative serum pregnancy test within 72 hours prior to the start of the study drug administration and to use effective contraception (such as an IUD, contraceptive pill or condom) during the trial period and for at least 3 months after the last drug administration; For male patients with a female partner of childbearing age, effective contraceptive measures should be taken during the trial and within 3 months after the last dose; 10. The patients had good compliance and could follow up the efficacy and adverse events/reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with unresectable factors, including tumor invasion of trachea or large blood vessels or surgical contraindications, who cannot be resectable or refuse surgery; 2. Poor nutritional status, BMI 10mg/ day prednisone or equivalent) in the 2 weeks prior to the initial use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and prednisone dose >10mg/ day or equivalent adrenocortical hormone replacement are permitted; (3) Received live attenuated vaccine within 4 weeks prior to the first administration of the study drug; (4) Major surgery or severe trauma within 4 weeks before the first use of the study drug; 5. A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation; 6. There are clinical cardiac symptoms or diseases that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without or after clinical intervention; 7. Severe infections (CTCAE 5.0 > 2), such as severe pneumonia, bacteremia, and infection complications requiring hospitalization, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic therapy, except when intravenous prophylactic antibiotics were administered for less than 48 hours; 8. Used other investigational drugs/treatments within 4 weeks prior to randomization; 9. Current patients with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or lung disease requiring hormone therapy, or other pulmonary fibrosis, mechanical pneumonia (e.g., bronchiolitis oblans), pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia that may interfere with the determination and management of immune-related pulmonary toxicity, patients with active pneumonia or severe lung function impairment on CT during screening; Active tuberculosis; 10. Patients with any active autoimmune disease or a history of autoimmune disease with a risk of recurrence [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients who can be controlled by hormone replacement therapy alone can be included)]; Patients with skin conditions that do not require systemic treatment, such as leucoplakia, psoriasis, alopecia, type 1 diabetes that can be controlled by insulin therapy, or patients with a history of asthma that has been in complete remission in childhood without any intervention can be enrolled; Patients with asthma requiring bronchodilator intervention were excluded; 11. Active hepatitis B (HBV-DNA >= 2000 IU/mL or 104 copies/mL), hepatitis C (HCV antibody po
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival;Overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactLi Zhigang
Outcome results
None listed