esophageal cancer
Conditions
Interventions
PD-1 combination therapy group:PD-1 combined with chemotherapy as neoadjuvant therapy
PD-L1 combination therapy group:PD-L1 combined with chemotherapy as neoadjuvant therapy
Sponsors
The Second Hospital & Clinical Medical School, Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 to 75 years old; 2. ECOG (Eastern Cooperative Oncology Group) PS (Physical Fitness Status): 0-2 points; 3. Esophageal cancer patient diagnosed as operable by histopathology (T2-4aN0-2M0). 4. There are measurable lesions that meet the RECIST 1.1 criteria; 5. Expected survival period >= 3 months; 6. Have sufficient organ and bone marrow function; 7. Thyroid function indicators: FT3, FT4, TSH normal or abnormal have no clinical significance; 8. Normal myocardial enzyme indicators; 9. Willing to use a medically recognized and highly effective contraceptive measure during the study period and within 6 months after the last administration of the study drug; For female participants of childbearing age, a serum pregnancy test must be conducted within 7 days before starting the study medication, and the result must be negative; No breastfeeding is allowed during the research period; 10. With my consent and signed informed consent form, I have good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1.If subjects are treated with corticosteroids for clinical symptoms, they must receive a stable or gradually decreasing dose of = 2000 IU/mL), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method) or people with co infection of hepatitis B and hepatitis C; 5. Within 14 days prior to the first use of the investigational drug, have used immunosuppressive drugs (i.e. not exceeding 10 mg/day of prednisone or its equivalent); 6. Vaccination with attenuated live vaccine within 4 weeks prior to the first administration or planned during the study period; 7. There is evidence of past or current pulmonary fibrosis, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severe impairment of lung function; 8. Uncontrollable hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 90 mmHg, despite optimal drug treatment); 9. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450ms in males and >= 470ms in females). According to NYHA standards, patients with grade III-IV heart failure, or those with left ventricular ejection fraction (LVEF)38.5° C during screening/before the first administration; 11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. Pregnant or lactating women; Patients with fertility who are unwilling or unable to take effective contraceptive measures; 13. It is known that there may be allergic reactions, hypersensitivity reactions, or intolerance to Adabelimab or Carilizumab; 14. The researcher believes that there are any conditions that may harm the subjects or cause them to be unable to meet or perform the research requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR; EFS;OS;safety; | — |
Countries
China
Contacts
Public ContactBin Li
The Second Hospital & Clinical Medical School, Lanzhou University
Outcome results
None listed