esophageal cancer
Conditions
Interventions
Experiment Group:Arterial infusion chemotherapy combined with arotinib and paampilizumab
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with esophageal squamous cell carcinoma of stage ?~? A (T1-4N1-3M0) confirmed by histopathology; 2. According to the evaluation standard of solid tumor efficacy RECIST version 1.1, there is at least one measurable focus; 3. Male or female patients aged 18-80; 4. ECOG PS score: 0-1; The expected survival period is more than 3 months; 5. It has sufficient organ and bone marrow functions, that is, it meets the following standards: 1) The blood routine examination standard should meet: a) Hemoglobin content (HB) = 90g/L (no blood transfusion within 28 days); b) Absolute neutrophil count (ANC) = 1.5 × 109/L c) Platelet count (PLT) = 100 × 109/L d) White blood cell count (WBC) = 4 × 109/L 2) Biochemical examination shall meet the following standards: a) Total serum bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); b) ALT and AST = 2.5ULN; c) Cr = 1.5ULN or creatinine clearance rate (CCr) = 60ml/min, (Cockcroft-Gault formula); 3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = lower limit of normal value (50%). 4) Coagulation function is sufficient, defined as international standardized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; 6. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine pregnancy test is negative within 7 days before the study enrollment, and must be a non-lactating patient, or meet one of the following criteria to prove that there is no pregnancy risk: 1) Postmenopause is defined as amenorrhea at least 12 months after the age of more than 50 years and the cessation of all exogenous hormone replacement therapy; 2) Women younger than 50 years of age can also be considered as postmenopausal if they have amenorrhea for 12 months or more after stopping all exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are within the range of laboratory postmenopausal reference values; 3) He has undergone irreversible sterilization operations, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, except for bilateral tubal ligation. Men should agree with patients who must use contraception during the study period and within 6 months after the end of the study period. 7. The patient voluntarily joined the study and signed the informed consent form, with good compliance.
Exclusion criteria
Exclusion criteria: 1. Esophageal squamous cell carcinoma patients with active bleeding within 2 months of the primary lesion; 2. Those who have multiple factors affecting oral medication (after gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.); 3. Allergies to arterial chemotherapeutic drugs, raw materials and excipients of arotinib and piazepril mab; 4. Patients with esophageal cancer ulcer type who are judged by the researcher to be prone to bleeding; 5. Patients with any serious and/or uncontrolled disease, including: 1) Patients with poor blood pressure control (systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg); Having myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QT interval = 430ms) and cardiac insufficiency of grade I (New York Heart Association (NYHA) cardiac function classification); 2) Active or uncontrolled serious infection; 3) Liver diseases such as cirrhosis, decompensated liver disease and chronic active hepatitis; 4) Poor control of diabetes (FBG>10mmol/L); 5) Urine routine test showed that urine protein =++, and confirmed that the 24-hour urine protein content was more than 1.0 g; 6. Wounds or fractures that have not been cured for a long time; 7. Pulmonary hemorrhage with NCI CTC AE V5.0 grade>1 occurred within 4 weeks before enrollment; Bleeding at other sites with NCI CTC AE V5.0 grade>2 occurred within 4 weeks before enrollment; Patients with bleeding tendency (such as active gastrointestinal ulcer) or undergoing thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues; 8. Have undergone major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks before the first dose of the study or are expected to undergo major surgery during the study treatment; 9. A history of gastrointestinal perforation and/or fistula within 6 months before treatment; Or have experienced arterial/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism; 10. Patients whose imaging shows that the tumor has invaded important blood vessels or who are judged by the researcher to be very likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 11. Ascites with clinical significance, including any ascites that can be found in physical examination, ascites that have been treated in the past or still need to be treated at present, can be selected if only a small amount of ascites is shown by imaging but without symptoms; 12. Patients with equal amount of effusion in both sides of the chest, or a large amount of effusion in one side of the chest, or who have caused respiratory dysfunction and need drainage; 13. Known to have active pulmonary tuberculosis; 14. Suffering from interstitial lung disease requiring steroid hormone treatment; 15. Uncontrolled metabolic disorders or other non-malignant tumor organs or systemic diseases or secondary reactions to cancer, which may lead to higher medical risks and/or uncertainty in survival evaluation; 16. Significant malnutrition, such as the need for intravenous nutrition; Except for those with malnutrition corrected for more than 4 weeks before the first dose of study treatment; 17. Those who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders; 18. Have a history of immunodeficiency, including those who are H
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR);Disease control rate(DCR);Duration of remission (DOR);Safety; | — |
Countries
China
Contacts
Public ContactXuhua Duan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed