esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group1:Camrelizumab(200mg,d1) combined with albumin bound paclitaxel(175mg/m2,d1) and carboplatin(AUC=5,d1), Q3W,for 2 cycle
Experimental group2:Camrelizumab(200mg,d1) combined with albumin bound paclitaxel(175mg/m2,d1) and carboplatin(AUC=5,d1), Q3W,for 4 cycle
Sponsors
Jiangsu Cancer Hospital
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. Aged 18 to 75 years, including 18 and 75 years old, no gender limit; 3. Biopsy pathological diagnosis of esophageal squamous cell carcinoma, patients with resectable esophageal cancer before enrollment; 4. Thoracic esophageal cancer assessed by CT/MRI and the clinical stage is T1b-3N1-3M0 or T3N0M0 (according to AJCC 8th edition); 5. Physical condition score ECOG 0-1 (see Annex 1 for the ECOG scoring standard); 6. Expected survival period >= 3 months; 7. Have not received any anti-tumor therapy for esophageal cancer before, including radiotherapy, chemotherapy, surgery, etc.; 8. No serious hematopoietic function, heart, lung, liver, kidney dysfunction and immune deficiency; 9. The main organ functions are normal, including (no blood components, cell growth factors, whitening drugs, platelet increasing drugs, and anemia correction drugs are not allowed to be used within 14 days before the first use of the study drug): Neutrophils>=1.5x10^9/L; Hemoglobin>=9g/dL; Platelets>=100x10^9/L; Total bilirubin<=1.5 times the upper limit of normal; AST (SGOT) and ALT (SGPT) <= 2.5 times the upper limit of normal; creatinine <= 1.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Esophageal perforation or hematemesis; 2. Have any active autoimmune disease or have a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (it can be included after hormone replacement therapy is effective), etc.), and use of immunosuppressive drugs within 28 days; 3. Known to be allergic to macromolecular protein preparations, or to any camrelizumab (SHR-1210) and its components; 4. Suffering from uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA class II heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4) subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 5. Suffering from congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B (HBV-DNA >= 10^4 copies/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or active tuberculosis; 6. Active infection or unexplained fever greater than 38.5°C within 2 weeks before randomization (subject to the investigator's judgment, the subject can be included in the group due to fever caused by tumor); 7. Males or females of childbearing potential are reluctant to take contraceptive measures in the trial, and female subjects are pregnant or breastfeeding; 8. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, for example, suffering from other serious diseases (including mental illness) requires combined treatment, and family or social factors may affect the safety of subjects or the collection of trial data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of subjects of pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Disease-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZhang Qin
Outcome results
None listed