esophageal cancer
Conditions
Interventions
Vagotomy group:vagotomy
vagus nerve preservation group:Vaginal nerve preservation surgery
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age range from 18 to 80, both males and females are eligible. Histologically confirmed esophageal squamous cell carcinoma. Potentially resectable stage II/III/IVA (cT1b-cT2N+ or cT3-cT4a any N) according to the 8th edition of AJCC staging. Expected survival time > 12 weeks. ECOG performance status: 0-2. Normal organ and bone marrow function, defined as follows: (1) Hemoglobin: = 100 g/L, white blood cells: = 3500 G/L, neutrophils: = 1500 G/L. (2) Platelets: = 100,000/mm^3. (3) Normal upper limit of creatinine, BUN within normal upper limit, AST/ALT: = 1.5 times the upper limit. (4) Total bilirubin: = 1.5 times the upper limit, alkaline phosphatase: = 1.5 times the upper limit. (5) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) = lower limit of normal (50%). Subjects should take appropriate contraceptive measures to prevent pregnancy during the clinical trial period or within six months after the trial. Subjects have good compliance, cooperate with the study protocol and follow-up work, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with any active autoimmune disease or a history of autoimmune disease. Patients who are currently receiving immunosuppressive therapy or steroids for the purpose of immunosuppression, and have been continuously using them within 2 weeks prior to enrollment. Patients with severe and/or uncontrolled diseases. Patients with active or uncontrolled severe infections. Patients with liver diseases such as decompensated liver disease, active hepatitis B or C. Patients with a history of other malignant tumors within the past 5 years (excluding cured basal cell carcinoma and cervical carcinoma in situ). Patients with mental disorders or a history of substance abuse that cannot be discontinued. Patients with lymph node metastasis in the clavicle. Patients with poor nutritional status, with a body mass index (BMI) <18.5 kg/m^2; if symptomatic nutritional support is provided and corrected before enrollment, consideration for inclusion can be made after assessment by the principal investigator. Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response, pCR;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| event free survival, EFS;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactLi Yadong
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed