Esophageal Squamous Cell Carcinoma
Conditions
Interventions
experimental group:Tirelizumab + radiotherapy + chemotherapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1) 18-75 years old; 2) Histopathological diagnosis was esophageal squamous cell carcinoma; 3) Clinical stage T1-2N1-3M0 or T4NanyM0 (AJCC, 8th Edition, 2017), with the upper boundary of the tumor at least 5cm from the esophageal entrance; 4) Have not received anti-tumor related treatment; 5) Patients with an ECOG score of 0-1 were included in the evaluation based on the activity scoring table developed by the Eastern Cooperative Oncology Group (ECOG) in the United States; 6) Adequate organ function: a) Blood routine examination (no blood transfusion, no use of granulocyte colony stimulating factor (G-CSF), no correction with other drugs within 14 days before treatment) Neutrophil count (NE)>1500/ µ L Hemoglobin count (HGB)>8.0 g/dL; Platelet count (PLT)>100 000/ µ L b) Blood biochemistry (liver and kidney function) Serum creatinine (Cr) = 1.5 × Upper limit of normal (ULN); Total bilirubin (TBIL) = 1.5 × ULN; AST or ALT levels = 2 × ULN 7) Sign the informed consent form to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1) Patients who have received the following medical interventions within 4 weeks before treatment: a) Participate in drug treatment of other clinical studies; b) Vaccination history of live attenuated vaccines. 2) Previously received monoclonal antibodies against programmed death molecule 1 (PD-1)/PD-1 ligand (PD-L1), cytotoxic lymphocyte associated antigen 4 (CTLA-4) antibodies, or other immune or molecular targeted therapies; 3) Patients who are completely unable to eat; 4) There is already a high risk of esophageal perforation or perforation; 5) Investigators judged that surgery was intolerable; 6) Patients with interstitial pneumonia, non infectious pneumonia, or pulmonary fibrosis; 7) Previous use of immunosuppressive drug glucocorticoids within 7 days before starting treatment; 8) There is any active autoimmune disease or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9) Active infection before treatment (such as the need for intravenous drip of antibiotics, antifungal, or antiviral drugs), or fever of unknown origin>38.5 ° C during screening/prior to first administration; 10) Metal implants or foreign bodies in the body (including but not limited to cardiac pacemakers and nerve stimulators) 11) Any other malignant tumor was diagnosed before treatment; 12) Known allergies to the study drug or any of its excipients, or severe allergic reactions to other monoclonal antibodies; 13) Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures; 14) According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subject, may confuse the study results, or affect the subject's completion of this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Major pathological remission;Pathological complete remission rate;Event Free Survival ; | — |
Countries
China
Contacts
Public ContactJiang Zhu
Sichuan Cancer Hospital
Outcome results
None listed