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. Aged 18 to 75 years; 2. Potentially resectable stage IIB~IVA esophageal cancer confirmed by histopathology or cytology, with at least one measurable lesion after treatment (long diameter of spiral CT scan >=10mm, meeting the requirements of RESCIST version 1.1); 3. ECOG PS score: 0-1 points; 4. Expected survival period >= 12 weeks; 5. The main organs are functioning normally, that is, the following criteria are met: (1) Routine blood examination: HB>=90 g/L (no blood transfusion within 14 days), ANC>=1.5x10^9/L, PLT >=80x10^9/L; (2) Biochemical tests: ALB>=30g/L (without ALB infusion within 14 days), ALT and AST=60 ml/min; 6. Patients 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; negative serum or pregnancy test within 7 days before study enrollment, must be non-lactating patients; males should agree to patients who must use contraceptives during the study and within 6 months after the end of the study; 7. The patients voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 8. Patients who the investigator believes can benefit.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors that have occurred or are currently at the same time within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)]; 2. Those who are allergic or sensitive to anlotinib, tislelizumab, paclitaxel liposome or nedaplatin; 3. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 4. Any serious and/or uncontrolled disease: patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); myocardial ischemia or myocardial infarction of grade I or above; arrhythmias (including QT interval >=480 ms) and class I cardiac insufficiency; 5. Active or uncontrolled serious infection; 6. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA>=104copies/ml or 2000IU/ml) or hepatitis C (positive for hepatitis C antibody and HCVRNA) are all higher than the lower limit of the analysis method; 7. Unrelieved toxic reactions higher than CTC AE grade 1 due to any previous treatment, excluding alopecia; 8. Those with multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 9. Urine routine indicates urine protein >=++, and confirmed 24-hour urine protein quantitative > 1.0 g; 10. Received major surgical treatment, incisional biopsy or obvious traumatic injury within 28 days before grouping; 11. Regardless of the severity, patients with any signs of bleeding constitution or medical history; patients with any bleeding or bleeding events >= CTCAE grade 3 within 4 weeks before assignment, with unhealed wounds, ulcers or fractures; 12. Those who have experienced arterial/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 13. Lactating patients; 14. Those with distant metastasis; 15. Liver and kidney insufficiency; 16. Patients with obvious bone marrow suppression; 17. Have a history of mental illness or abuse of psychotropic substances; 18. Patients who have participated in clinical trials of other drugs within 4 weeks; 19. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study; 20. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;RO resection; | — |
Countries
China
Contacts
Public ContactMa Jie
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed