Esophageal squamous cell carcinoma
Conditions
Interventions
Queue A:Cohort A received neoadjuvant immunotherapy combined with chemotherapy
Queue B:Cohort B was treated with neoadjuvant immunotherapy combined with chemotherapy followed by radiotherapy
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.He was diagnosed as squamous cell carcinoma by gastroscopic biopsy. 2.According to the AJCC/UICC 8th edition staging system, the tumor was cT2-4aN0-1M0 after chest and abdominal enhanced CT, neck ultrasound, PET-CT and other examinations. 3.Age 18-75 years old; 4.ECOG score of physical condition 0-1; 5.Life expectancy greater than 3 months; 6.The patient has no indication for emergency surgery; 7.No recent childbearing requirement; 8.The main organs function well, the examination indicators meet the following requirements: blood routine examination: hemoglobin >=90 g/L (no blood transfusion within 14 days); Neutrophil count >=1.5×10^9/L; Platelet count >=75×10^9/L; Biochemical examination: total bilirubin = 50 ml/min (Cockcroft-Gault formula); Blood coagulation function is normal; Normal lung function; 9. Sign informed consent;
Exclusion criteria
Exclusion criteria: 1.With other malignant tumors, except those that have been cured or whose disease is stable; 2.Patients with any unstable systemic disease (including active infection, poorly controlled moderate to severe hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease, etc.) that prevents them from tolerating treatment; 3.Those who have received or are receiving other chemotherapy, radiation, or targeted therapy; 4.Pregnant or lactating women; 5.Co-use of antitumor drugs outside the study protocol; 6.A known or suspected history of autoimmune disease or immunodeficiency, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; 7.In the judgment of the investigator, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate after neoadjuvant therapy combined with immunotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;R0 resection rate;Pathological downphase rate;Objective response rate;EFS rate in one year;3-year OS rate; | — |
Countries
China
Contacts
Public ContactFan Hong/ Yao Guangyu
Zhongshan Hospital, Fudan University
Outcome results
None listed