Esophageal squamous cell carcinoma (ESCC)
Conditions
Interventions
Experimental group:Immunomodulatory Low-dose Radiotherapy Combined With Chemoimmunotherapy of Tirelizumab, Paclitaxel (albumin bound), and Carboplatin
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. age = 18 years old, = 75 years old, regardless of gender (> 75 years old but in excellent physical condition, those who can tolerate the treatment of this study protocol after MDT discussion can also be individualized into the group); 2. thoracic esophageal squamous cell carcinoma confirmed by pathology; 3. TNM staging was performed using the Union for international cancer control (UICC) / American Joint Committee on cancer (AJCC) Eighth Edition ctnm system, and regional lymph node grouping was performed using the Japanese esophageal Society (Jes) esophageal cancer lymphatic drainage grouping system. According to the MDT discussion of esophageal cancer, the initial stage of esophageal squamous cell carcinoma that cannot be completely (R0) resected is: cT3-4NxM0 and or incomplete (R0) resection of lymph nodes: cT2-4N+M0, stage ?-?a; 4. ECOG PS score: 0-1; 5. have not received any systemic anti-tumor treatment in the past (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biological therapy, local therapy and other research treatment drugs); 6. adequate baseline organ function. The following blood routine indicators shall be met: ? neutrophil count = 1.5 × 109/l; ? Hemoglobin = 90g/l; ? Platelet count = 100 × 109/l; The following blood biochemical indexes shall be met: ? ALT and AST = 2.5 × ULN; ? Total bilirubin = 2 × ULN; ? Plasma Cr = 1.5 × ULN, or CCR = 60ml/min; 7. the blood pressure of hypertensive patients should be controlled within the normal range with antihypertensive drugs, and the fasting blood glucose of diabetic patients should be controlled at = 8mmol/l with hypoglycemic drugs; 8. international normalized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 × ULN (for those who use stable doses of anticoagulant therapy, such as aspirin, low molecular weight heparin or warfarin, and whose INR is within the expected treatment range of anticoagulants, and have no active bleeding tendency, they can be screened); 9. female subjects with fertility should have a urine or serum pregnancy test within 72 hours before receiving the first dose of study drug and prove to be negative, and are willing to use effective methods of contraception from the test period to 5 months after the last dose. For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 7 months after the last administration. 10. there are no other serious diseases (such as autoimmune diseases, immunodeficiency, organ transplantation or other diseases requiring continuous hormone treatment) that conflict with this protocol; 11. no history of other malignancies; 12. the patient agreed to participate in this clinical study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. cervical esophageal cancer; 2. the pathological type is non squamous cell carcinoma or mixed pathological type, or combined with other incurable malignant tumors (except cured non malignant black skin tumors, cervical cancer in situ, prostate cancer); 3. the patient has previously received anti-tumor treatment (including chemotherapy, radiotherapy, surgery or immunotherapy); 4. the patient has or is expected to have significant risks of esophageal perforation, fistula and massive bleeding; 5. for active autoimmune or immunodeficiency diseases, immunosuppressants were used before enrollment, and the dosage of immunosuppressants used was = 10mg/ day, and the dosage of oral prednisone continued for more than 2 weeks; 6. clinically obvious cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention, left ventricular ejection fraction 16S, APTT > 53s, TT > 21s, FIB < 1.5g/l), who are receiving thrombolytic or anticoagulant therapy and have active bleeding tendency; 12. previous or current severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, severe impairment of lung function, or active tuberculosis within 1 year; 13. there is uncontrollable active hepatitis B or C; 14. there are those who do not meet the enrollment conditions according to the evaluation of other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete resection rate (R0) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| conversion rate;Objective response rate;Pathological complete response rate;Major pathologic response;2-year event-free survival;2-year overall survival; | — |
Countries
China
Contacts
Public ContactWei Ren; Zhendong Hu
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed