Esophageal squamous cell carcinoma
Conditions
Interventions
Treatment group:kadunilimab
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject is able to understand the informed consent form, voluntarily participate and sign the informed consent form; 2. Age 18-75 years old, male or female; 3. Patients with resectable esophageal squamous cell carcinoma confirmed by histopathology or cytology; 4. Patients with pathological stage cT1b-cT2N+ or cT3-cT4aNany. 5. Have not received previous anti-tumor treatment (such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. According to the efficacy evaluation criteria for solid tumors (RECIST1.1), there is at least one measurable lesion, and the measurable lesion should not have received local treatment such as radiotherapy; 7. ECOG score 0-1; 8. Expected survival= 12 weeks; 9. No serious abnormal blood system, heart and lung function and autoimmune defects; 10. Blood routine indexes: white blood cells (WBC) = 3.0 × 109/L; Absolute neutrophil count (ANC) = 1.5 × 109/L; Platelet (PLT) = 100 × 109/L; hemoglobin (Hgb) =90 g/L; 11. Blood biochemical indexes: AST(SGOT), ALT (SGPT)=2.5 × upper limit of normal value (ULN); Total bilirubin (TBIL) =ULN; serum creatinine (CRE) =1.5 × ULN; 12. Coagulation function: prothrombin time (PT), international normalized ratio (INR) = 1.5 × ULN; 13. Ejection fraction > 50% on echocardiography before treatment start; 14. Subject is competent and willing to comply with visits, treatment plans, laboratory tests, and other research-related procedures as prescribed by the study protocol.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of distant metastasis by CT/MR/PET-CT; 2. Previous anti-PD-1, anti-PD-L1, or anti-CTL-A4 antibody therapy, or any other antibody or drug specific target with T-cell co-stimulation or checkpoint pathways; 3. Other malignant tumors in the past 5 years; 4. Uncontrollable pleural effusion, pericardial effusion, or ascites; 5. Severe cardiovascular disease, such as symptomatic coronary heart disease, congestive heart failure of grade = II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrollment; 6. Complicated by severe uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; 7. Have uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; known history of HIV infection or AIDS; Active syphilis; active tuberculosis; Active infection; uncontrolled hypertension, symptomatic cardiac insufficiency; Active bleeding; 8. History of interstitial lung disease (except radiation pneumonia not treated with national hormones) and non-infectious pneumonia; 9. Have an allergic reaction to the drugs used in this study; 10. Use of steroids or other systemic immunosuppressive therapy 14 days prior to recruitment; 11. Pregnant or lactating women or women of childbearing age who have a positive baseline pregnancy test; 12. Patients assessed by investigators to have poor patient compliance and could not guarantee treatment and follow-up according to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate;Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Disease control rate;Objective response rate;Safety; | — |
Countries
China
Contacts
Public ContactMa Minjie
The First Hospital of Lanzhou University
Outcome results
None listed