Esophageal cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 ~ 75 years old, male or female; 2. Potential resectable stage IIb ~IVA esophageal squamous cell carcinoma confirmed hiopathologically or cytologically, with at least one treatable measurable lesion (spiral CT scan diameter >= 10mm, meeting the requirements of RESCIST version 1.1); 3. ECOG PS score: 0-1; 4. Expected survival >= 12 weeks; 5. The major organs are functioning normally, that is, they meet the following criteria: (1) Blood routine examination: A.Hacuity 90 g/L and B (No blood transfusion within 14 days) B.ANC acuity 1.5 x 10^9 / L; C.PLT 80 x 10^9 / L or higher; (2) Biochemical examination: A. ALB acuity 30 g/L; (No ALB delivered within 14 days) B. ALT and AST = 60 mL /min; 6. Women of child-bearing age should consent to the use of contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for 6 months after the study's completion; Negative sera or pregnancy test within 7 days prior to study enrollment must be non-lactating; Men should agree to use contraceptives during the study period and within 6 months after the end of the study; 7. Subjects voluntarily participate in this study, sign informed consent, good compliance, and cooperate with follow-up. 8. Patients whom the investigator believes could benefit.
Exclusion criteria
Exclusion criteria: 1. Previous or current concurrent malignancy within 1.5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [TA (non-invasive tumor), TIS (carcinoma in situ), and T1 (tumor invasion of basal membrane)]; 2. Allergies or sensitivities to amrotinib, paclitaxel liposomes or nedaplatin; 3. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 4. Any serious and/or uncontrolled disease: patients with unsatisfactory blood pressure control (SBP >= 150 mmHg or Diastolic blood pressure >= 100 mmHg); Grade I or higher myocardial ischemia or myocardial infarction; Arrhythmia (including QT interval >= 480 ms) and grade I cardiac insufficiency; 5. Active or uncontrolled severe infection; 6. Decompensated liver disease, active hepatitis B (HBV-DNA >= 10^4 copies/ml or 2000IU/ml) or hepatitis C (positive hepatitis C antibody and HCVRNA) were all above the lower limit of the analysis method: 7. Unmitigated toxic reactions above CTC AE grade 1 due to any prior treatment, excluding hair loss; 8. People with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 9. Routine urine indicated urinary protein >= ++, and confirmed 24-hour urinary protein quantitative > 1.0 g; 10. Major surgical treatment, open biopsy or significant traumatic injury had been received within 28 days before the grouping; 11. Patients with any signs or history of bleeding regardless of severity; During the 4 weeks prior to grouping, patients with any bleeding or bleeding event >= CTCAE grade 3 had unhealed wounds, ulcers or fractures; 12. 6 months after the occurrence of arterial/venous thrombosis events, such as cerebral vascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism; 13. Pregnant or lactating women; 14. Distant metastases; 15. Liver and kidney dysfunction; 16. Patients with obvious bone marrow suppression; 17. Have a history of mental illness or abuse of psychiatric substances; 18.Patients who participated in clinical trials of other drugs within 4 weeks; 19. Patients with a concomitant disease that, in the Investigator's judgment, seriously endangers patient safety or affects patient completion of the study; 20. Those considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;OS; | — |
Countries
China
Contacts
Public ContactJie Ma
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed