esophageal cancer
Conditions
Interventions
RAMIE:Robotic assisted
OE:Open surgery
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. squamous cell carcinoma was diagnosed by gastroscopy or cytologic examination; 2. primary tumor in thoracic esophageal cancer, the primary site decided to lump the esophageal margin position (upper thoracic esophagus: from the thoracic entrance, next to the azygos vein arch, endoscopy of the incisor teeth of 20 cm to 4.0 * 10^9/L: blood leukocyte, neutrophil (ANC) counts over 2 * 10^9/L * 10^9 /L >100, platelet count and hemoglobin >90g/L lung function: FEV1 = 1.2L; FEV1% = 50%, DLCO = 50% and FEV1: (L): FVC measured value (L). FEV1%: measured / estimated value of forced vital capacity. DLCO%: carbon monoxide breath diffusion function measured value / expected value%; liver function: serum bilirubin is lower than the maximum normal value 1.5 times; ALT and AST are lower than the maximum normal value 1.5 times. Renal function, serum creatinine (SCr) less than or equal to 120 mu mol/L, creatinine clearance rate (CCr) = 60ml/min; 6. understand the situation of this study and sign informed consent.
Exclusion criteria
Exclusion criteria: Cancer related exclusion criteria: 1. transthoracic abdominal enhanced CT, cervical lymph nodes and body PET-CT (optional) or EBUS (optional) imaging to determine the clinical stage cT1-2N0-1M0 (AJCC/UICC version eighth), stage T4b unresectable (by two senior Department of thoracic surgery physicians judge) and multiple lymphadenopathy (estimated lymph = 3) node metastasis and multi station lymph nodes (estimated lymph node stations more than 2) or distant metastasis (M1) patients; 2. having been or undergoing additional chemotherapy, radiation therapy, or targeted therapy; 3. gastroscopy showed non squamous cell carcinoma; 4. patients who have previously suffered from other cancers (except those who have been diagnosed with cervical carcinoma or local basal cell carcinoma); 5. A history of congestive heart failure confirmed; drug treatment of poorly controlled angina; electrocardiogram (ECG) transmural myocardial infarction confirmed; poorly controlled hypertension; valvular heart disease with clinical significance; or high-risk cannot control arrhythmia; 6. severe uncontrolled generalized systemic diseases such as active infection or poorly controlled diabetes mellitus; 7. abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer), or undergoing thrombolysis or anticoagulant therapy; 8. serum pregnancy tests were positive or were in lactating women, and reproductive age men and women who were reluctant to adopt adequate contraception during the study of medications; 9. known immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), active infection, or known HIV seropositive; 10. is known to be allergic to any research drug; 11. have a history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 12. there are peripheral nervous system disorders or those with obvious mental disorders and disorders of the central nervous system; 13. patients with antineoplastic agents were included in the study. 14. participate in other clinical studies simultaneously. Rejection standard: 1. patients who are not treated according to the study plan, methods, and course of treatment; 2. subjects withdrew informed consent and asked to quit the test; 3. the researchers believe that the subject is not suitable for continued treatment for some reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3y-OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3y-DFS;Perioperative index;postoperative quality of life; | — |
Countries
China
Contacts
Public ContactXufeng Guo
Shanghai Chest Hospital
Outcome results
None listed