Esophageal squamous cell carcinoma
Conditions
Interventions
Single Arm:tislelizumab in combination with liposome paclitaxel+cisplatin
Sponsors
Sixth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age:18 to 75 years old; 2. Histology comfirmed as esophageal squamous cell carcinoma; 3. Clinical tumor stage:T2-4aN0M0,T1-4aN+M0; 4. According to RECIST 1.1 ,at least one measurable lesion; 5. ECOG PS :0~1; 6. Operative patient; 7. The main organs function normally,it must met the following criteria; (1) Blood routine examination A. HB >= 90g/L; B. ANC >= 1.5 x10^9 / L; C. PLT >= 80 x 10^9 / L; (2) biochemical examination A. ALB >= 30g / L; B. ALT and AST <= 2.5ULN; C. TBIL <= 1.5ULN; D. plasma Cr <= 1.5ULN. 8. left ventriculaor ejection fraction(LVEF)normal low limit (50%); 9. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 10. participants voluntarily joined the clinical trial,signed the informed consent,good adhereence,and were well-adhereed to follow up.
Exclusion criteria
Exclusion criteria: 1. Have used immunosuppressive drugs within 14 days before adminstration,dose not include nosel and inhaled corticosteriods or physiological dose of systemic steriod hormones(no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose); 2. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 3. Patients with other malignancies within 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 4. HIV infection or acquired immunodeficiency syndrome,active hepatitis B (HBV-DNA >= 1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study; 5. 6 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male> 450 ms, female> 470 ms, The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism), in stable phase, need a cardiovascular physician evaluation; 6. Severe infections within 4 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or > 38.5 degrees C during screening visits or on the first scheduled day of dosing; 7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Less than 4 weeks from the last clinical trial; 9. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 10. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 reaction rate;Objective response rate;Media disease-free survival;Media overall survival;Safty; | — |
Countries
China
Contacts
Public ContactGong Taiqian
Sixth Medical Center of PLA General Hospital
Outcome results
None listed