Esophageal carcinoma
Conditions
Interventions
Robotic Assisted Ivor Lewis (RA-IL):Robotic Assisted Ivor Lewis (RA-IL)
Thoracoscopic Ivor Lewis(TL-IL):Thoracoscopic Ivor Lewis(TL-IL)
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 80 years old, regardless of gender; 2. Pathological diagnosis: Adenocarcinoma or squamous cell carcinoma 3. Tumor staging: cT1-2N0M0 or cT1-2N+M0 assessed as resectable after neoadjuvant therapy, T3-4aNanyM0 4.ECOG score: 0 - 1; 5.ASA: Grade I - III 6.Normal function of major organs, that is, meeting the following criteria: (1) Routine blood test: a. HB = 90g/L; b. ANC = 1.5 × 109/L; c. PLT = 80 × 109/L; (2) Biochemical test: a. ALB = 30g/L; b. ALT and AST = 2.5 ULN; c. TBIL = 1.5 ULN; d. Plasma Cr = 1.5 ULN or creatinine clearance rate (CCr) = 60 ml/min; 7. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%); 8. Women of childbearing age should agree to take contraceptive measures (such as intrauterine devices, contraceptives or condoms) within 6 months during the study and after the study ends; Serum or urine pregnancy tests should be negative within 7 days before study enrollment, and they must be non-lactating patients; Men should agree to take contraceptive measures within 6 months during the study and after the study period for patients; 9. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1) Patients with contraindications to neoadjuvant therapy, such as paclitaxel and platinum allergy or metabolic disorders, are excluded. Additionally, patients with any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism) are also excluded. The patient had vitiligo. Children who experienced complete remission of asthma during childhood and did not require any intervention in adulthood may be included. However, patients with asthma requiring medical intervention using bronchodilators are excluded from the study. Furthermore, patients receiving immunosuppressive or systemic hormone therapy for immunosuppression (prednisone at a dose of >10mg/day or equivalent efficacy hormone) within 2 weeks prior to enrollment are ineligible. Patients with severe and/or uncontrolled medical conditions including poorly controlled blood pressure (systolic blood pressure =150mmHg or diastolic blood pressure =100 mmHg), grade I or above myocardial ischemia or myocardial infarction; arrhythmia (including QT interval =480ms); grade I cardiac insufficiency; severe active infection; decompensated liver disease; active hepatitis B (HBV-DNA=104 copies/ml or 2000IU/ml) or hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method); urinary protein =++ and confirmed 24-hour urinary protein quantitation >1.0g are all excluded from participation in this study. 2) pregnant or lactating women; 3) Patients with other malignant tumors within 5 years (except for basal cell carcinoma of the skin and carcinoma in situ of the cervix that have been cured); 4) Patients with a history of psychotropic drug abuse and cannot be quit or patients with mental disorders; 5) Patients who have participated in clinical trials of other drugs within four weeks; 6) Preoperative planning requires resection of other organs, such as gallbladder, thyroid, liver, etc 7) Severe spinal deformity; 8) According to the judgment of the investigator, patients with concomitant diseases (such as acute myocardial infarction, cerebral infarction, pulmonary embolism, etc.) that seriously endanger the safety of patients or affect the completion of the study; 9) Those who are considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival;Perioperative safety; | — |
Countries
China
Contacts
Public ContactLi Xiangnan
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed