Esophageal carcinoma
Conditions
Interventions
Treatment group:Pabolizumab combined with preoperative chemotherapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male and female; 2. Thoracic esophageal squamous cell carcinoma with cervical lymph node metastasis; 3.ECOG: 0 ~ 1; 4. Expected survival =12 weeks; 5. If the major organs function normally, the following criteria are met: (1) Blood routine examination: a.HB=90g/L; b.ANC=1.5×10^9/L; C. PLT =80×10^9/L; (2) Biochemical examination: a.ALB=30g/L; B.lt and AST=2.5ULN; In the presence of liver metastasis, ALT and AST=5ULN; C.bil =1.5ULN; d. Plasma Cr=1.5ULN or creatinine clearance (CCr)=60ml/min; 6. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%); 7. Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period; 8. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Does not meet the above inclusion criteria; 2. Allergic or metabolic disorder to paclitaxel and platinum; 3. Patients with brain metastases; 4. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included); 5. Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormones) and continue to use within 2 weeks before enrollment; 6. Patients with any severe and/or uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure =150mmHg or diastolic blood pressure =100 mmHg); Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QT interval =480ms) and grade I cardiac insufficiency; 7. Active or uncontrolled severe infection; 8. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA=104 copy number /ml or 2000IU/ml), or hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower detection limit of analytical methods); 9. Urine routine indicated urine protein =++, and confirmed 24-hour urine protein quantity > 1.0g; 10. Pregnant or lactating women; 11. Patients who have had other malignancies within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 12. Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 13. Patients who have participated in clinical trials of other drugs within four weeks; 14. Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study; 15. Those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission;Multi-plane 3D reconstruction;Resection rate;Local recurrence rate;Transfer rate;Recurrence-free survival;Overall survival rate;Operative complication; | — |
Countries
China
Contacts
Public ContactLi Xiangnan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed