Esophageal squamous cell carcinomas
Conditions
Interventions
Case series:Amrotinib hydrochloride combined with paclitaxel liposomes and neda platinum
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 male or female; 2. A histopathologically or cytologically diagnosed potentially resectable esophageal squamous cell carcinoma of the IIB~IVA stage, with at least one treatable measurable lesion (length diameter of spiral CT scan >=10mm, meeting the requirements of RESCIST 1.1 standard); 3. ECOG PS score 0-1; 4. Expected survival >=12 weeks; 5. If the main organ functions normally, the following criteria shall be met: (1) blood routine examination: HB 90 g/L and B (no blood transfusion within 14 days); ANC 1.5x10^9/L; PLT 80x10^9/L or higher; (2) biochemical examination: ALB 30 g/L; (no ALB input within 14 days); ALT and AST =60 ml/min; 6. Women of child-bearing age shall agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for a period of six months after the end of the study; If the serum or pregnancy test is negative within 7 days before study registration, the patient must be non-lactating; Men should agree with patients who must use contraception during the study period and within 6 months of the end of the study; 7. Subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up; 8. Patients who researchers believe could benefit.
Exclusion criteria
Exclusion criteria: 1. Have developed or present with other malignant tumors within 1.5 years, with the exception of cured carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 2. Allergic or sensitive to orotinib, paclitaxel liposomes or nedaplatin; 3. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency, 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); Grade I or above myocardial ischemia or myocardial infarction; Arrhythmia (including QT interval >=480ms) and grade I cardiac dysfunction; 5. Active or uncontrolled severe infections; 6. Decompiled liver disease, active hepatitis b (hbv-dna >=10^4copies/ml or 2000 IU/ml) or hepatitis C (hepatitis c antibody and HCVRNA positive) and other liver diseases were all higher than the lower limit of the analysis method; 7. Unrelieved toxic reactions higher than CTC AE level 1 due to any previous treatment, excluding alopecia; Having multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 9. Urine routine indicated that urine protein >=++, and confirmed the 24-hour urine protein quantitative > 1.0g; 10. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days prior to grouping; 11. Patients with any physical signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event >=CTCAE grade 3 within the first 4 weeks of the grouping had unhealed wounds, ulcers or fractures; 12. 6 months after the occurrence of an avt event, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 13. Pregnant or nursing women; 14. Distant metastases; 15. Liver and kidney insufficiency; 16. Patients with significant myelosuppression; 17. A history of mental illness or substance abuse; Patients who have participated in clinical trials of other drugs within 18.4 weeks; 19. According to the judgment of the researcher, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 20. Not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;RO resection rate; | — |
Countries
China
Contacts
Public ContactMa Jie
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed