Locally advanced esophageal squamous cell carcinoma
Conditions
Interventions
Adbelimab combined with chemotherapy:Adbelimab combined with chemotherapy
Surgery
Sponsors
Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily participated in this study, signed the informed consent form, had good compliance and cooperated with the follow-up. 2. Age: 18 to 75 years old, including both 18 and 75 years old, both male and female are acceptable. 3. Patients with esophageal squamous cell carcinoma diagnosed by biopsy pathology and who were surgically resectable before enrollment; 4. It was evaluated as thoracic esophageal cancer by CT/MRI images and the clinical stage was (cT1a-3N2 M0, cT3N1 M0, stage III;cT4aN2-3M0 (Phase IVA), AJCC 8th; 5. Physical condition score: ECOG 0-1 (ECOG scoring criteria are attached as Appendix 1); 6. The expected survival period is >=3 months; 7. Has not received any previous anti-tumor treatment for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc. 8. There are no serious abnormalities in hematopoietic function, heart, lung, liver or kidney function, or immune deficiency. 9. Normal functions of major organs, including (no blood components, cell growth factors, leukopeners, platelet-raising drugs, or anemia-correcting drugs are allowed to be used within 14 days before the first use of the study drug) : neutrophils >=1.5×10^9/L;Hemoglobin >=9g/dL;Platelet count >=100×10^9/L;Total bilirubin <=1.5 times the upper limit of the normal value;AST (SGOT) and ALT (SGPT)<=2.5 times the upper limit of normal values;Creatinine <=1.5 times the upper limit of the normal value. 10. The subjects voluntarily joined this study, had good compliance, and cooperated with the follow-up of safety and survival.
Exclusion criteria
Exclusion criteria: 1. Esophageal perforation or hematemesis; 2. Have any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitinitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after effective hormone replacement therapy), etc.) and use immunosuppressants within 28 days; 3. It is known that there is an allergy to large molecule protein preparations, or to any adbelimab (SHR-1316) and the components in its preparations; 4. Suffering from uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris (3) Had a myocardial infarction within one year;(4) Patients with clinically significant supraventricular or ventricular arrhythmias who require clinical intervention; 5. Suffering from congenital or acquired immune dysfunction (such as HIV-infected individuals), active hepatitis B (HBV-DNA>=10^4 copies/ml) or hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method) or active tuberculosis; 6. There is an active infection or a fever of unknown cause > 38.5? occurred within 2 weeks before randomization (as judged by the researcher, the fever caused by the tumor in the subjects can be included in the group); 7. Fertile men or women who are unwilling to take contraceptive measures in the trial, and female patients who are pregnant or lactating; 8. According to the researcher's judgment, the subject has other factors that may cause them to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, family or social factors that may affect the subject's safety or the collection of trial data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main pathological response rate; | — |
Countries
China
Contacts
Public ContactCheng Meiying
Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)
Outcome results
None listed