esophageal squamous cell carcinoma
Conditions
Interventions
Intervention group:the neoadjuvant therapy of calirizumab combined with carboplatin and albumin paclitaxel
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patient must be confirmed as esophageal squamous cell carcinoma by the pathologist (excluding mixed adenosquamous carcinoma and other pathological types). 2. The age is >= 18 years old and = 1.5 x 10^9 g/dL, platelet count (PLT) >= 100 x 10^9 / L, hemoglobin (HB) >= 9.0 g/dL. 2) liver function: serum total bilirubin (TBIL) = 60 mL/min (calculated by Cockcroft /Gault formula): 4) the coagulation function is sufficient, which is defined as the international standardized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN;If the subject is receiving anticoagulant therapy, as long as PT is within the range of anticoagulant drugs. 9. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the treatment period. 10. Patients should sign a written informed consent form and be able to comply with the follow up and related procedures stipulated in the protocol. 11. It can provide archived pathological tissue or fresh pathological tissue within 6 months for the detection of PD-L1 and other biomarkers.
Exclusion criteria
Exclusion criteria: 1. Patients used other clinical trial drugs at the same time. 2. Patients who have recently undergone major surgery but have not recovered. 3. Previous treatment with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137 or anti-ctla-4 antibodies, or any other antibodies or drugs specifically targeting T cell co-stimulation or checkpoint pathways. 4. Known allergy to any monoclonal antibody or chemotherapy drug (paclitaxel, carboplatin), preparation or excipients. 5. Patients who also take rifampicin, phenytoin sodium, carbamazepine, and barbiturates (these drugs induce CYP3A and may reduce plasma paclitaxel levels). 6. Received systemic treatment with anti-tumor indications of Chinese herbs or immunoregulatory drugs (including thymosin, interferon, interleukinin, etc.) within 2 weeks before the first therapy. 7. Receive live attenuated vaccine within 4 weeks prior to or during the study period before the first therapy of the study treatment. Note: inactivated virus vaccines against seasonal influenza are allowed within 4 weeks prior to first administration; But live attenuated flu vaccines are not allowed. 8. Before the first therapy, there was a preexisting cancer caused by antitumor therapy that did not return to the national cancer of the United States Institute of disease research general adverse event terminology version 5.0 (NCI CTCAE version 5.0) level 0 or level 1 toxicity (excluding hair loss, non-clinically significant, and asymptomatic laboratory abnormalities). 9. There is active known autoimmune disease and symptomatic treatment of the disease or before 2 years history (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can be set). 10. A known history of primary immunodeficiency. 11. Active tuberculosis is known. 12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 13. HIV infection and carriers (HIV antibody positive) are known. 14. Severe infections in the active phase or with poor clinical control. 15. Symptomatic congestive heart failure (New York cardiology association class II-IV) or symptomatic or poorly controlled arrhythmias. 16. Uncontrolled arterial hypertension (systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg), even with standard treatment. 17. Any arterial thromboembolic events occurred in the 6 months prior to inclusion, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack. 18. Significant malnutrition, such as the need for intravenous supplementation; Malnutrition correction for more than 4 weeks prior to the first dose of study and treatment was excluded. 19. A history of deep venous thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months prior to enrollment.(Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, is not considered "serious" thromboembolism). 20. Uncontrolled metabolic disorders or other non-malignant organ or systemic disease or cancer secondary responses can lead to higher medical risk and/or uncertainty in the evaluation of survival. 21. Hepatic encephalopathy, hepatorenal syndrome or child-pugh grade B or more severe cirrhosis. 22. History of intestinal obstruction or any of the following: inflam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events;The safety of surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to treatment;Major pathological response rate;Evaluation of pathological response to therapy;Disease-free survival (DFS);Overall survival (OS);Quality of Life;Biomarkers associated with immunotherapy; | — |
Countries
China
Contacts
Public ContactCheng Chao
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed