Liver metastasis
Conditions
Interventions
Test group:Taxol cationic liposomes for injection, oxaliplatin, capecitabine
Sponsors
Lishui Central Hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18~75 (inclusive) years old, gender unlimited. 2. Untreated liver metastases, including but not limited to gastric cancer, colorectal cancer and pancreatic cancer, with the primary focus confirmed by histopathology or cytology. 3. If the liver metastasis is a single measurable target lesion, the diameter of the single target lesion is required to be = 2cm; If the liver metastasis is = 2 target lesions, at least 2 target lesions with diameter = 1cm are required. 4. ECOG physical state score: 0-2 points. 5. The estimated survival time is more than 3 months. 6. The function of main organs should meet the following standards before treatment: routine blood test Absolute neutrophil count (ANC) = 1.5 × 10^9/L Platelet = 90 × 10^9/L Hemoglobin = 90 g/L kidney Serum creatinine = 1.5 × Upper limit of normal range (ULN) liver Total bilirubin = 1.5 × ULN (including subjects with liver metastasis or liver cancer) Gilbert syndrome subjects: = 3 × ULN AST and ALT = 2.5 × ULN Subjects with liver metastasis or liver cancer: = 5 × ULN Coagulation International normalized ratio (INR) or prothrombin time (PT) = 1.5 × ULN Partial activated thromboplastin time (APTT) = 1.5 × ULN 7. Women should agree to use contraception (such as intrauterine device [IUD], contraceptive pill or condom) during the study period and within 6 months after the end of the study; The serum pregnancy test was negative within 7 days before the study was proposed to be enrolled, and must be a non-lactating subject; The male should agree to the subject who must use contraception during the study period and within 6 months after the end of the study period. 8. Subjects must give informed consent to the study before the test and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. The adverse reactions of the previous anti-tumor treatment have not recovered to the CTCAE 5.0 grade evaluation = 1 (except for the toxicity that the researchers judged to have no safety risk such as alopecia). 2. Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, and the researcher judged that it is not suitable for inclusion. 3. Active infection within 2 weeks before administration (NCI CTC AE v5.0 = grade 2). 4. Those with grade II or above peripheral neuropathy (NCI CTC AE v5.0). 5. Those who have a history of autoimmune diseases and immunodeficiency, including HIV test positive, or have other acquired or congenital immunodeficiency diseases, or are using immunosuppressants. 6. hepatitis B surface antigen positive (HBsAg) or hepatitis B core antibody positive (HBcAg), and the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer test = 2 × 103 IU/mL subjects. 7. Subjects with positive anti-hepatitis C virus antibody and HCV-RNA higher than the lower limit of the central detection value. 8. If the specific antibody against Treponema pallidum is positive and the non-specific antibody is positive, the researcher judges it as an active syphilis subject. 9. Those with known history of allergy to liposomes or paclitaxel. 10. Those who need to receive the combination of CYP2C8 and CYP3A4 strong inducers and strong inhibitors within 2 weeks before or during the treatment of the first study. 11. Cardiac abnormalities, including: 1) Diagnosis of long QT syndrome or QTcF in screening period = 450ms for men and = 470ms for women (only one ECG review is allowed during screening period, subject to the results of the last ECG in screening period); 2) High degree of atrioventricular block; 3) Malignant arrhythmia with poor drug control; 4) History of chronic heart failure and NYHA cardiac function grade = 3; 5) Severe cardiac valve regurgitation or stenosis requiring treatment; 6) Acute coronary syndrome and serious myocardial disease within 6 months before screening, including: primary cardiomyopathy and other serious myocardial diseases evaluated by researchers; Serious pericardial diseases, including acute pericarditis, constrictive pericarditis and other serious pericardial diseases evaluated by researchers; 7) Poor control of hypertension (defined as: under the control of antihypertensive drugs, systolic blood pressure is greater than 160mmHg or diastolic blood pressure is greater than 100mmHg for = 3 times); 8) Echocardiography showed LVEF<50%; 12. Subjects who have a history of severe neurological or mental disorders (including epilepsy or dementia) in the past, affecting the test compliance. 13. Thrombosis or embolism occurred within 6 months before the first administration, such as cerebrovascular accident (including transient ischemic attack) and pulmonary embolism; 14. Other researchers consider it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicity(DLT);Maximum tolerated dose(MTD);Adverse events: occurrence of all adverse events (AEs) and serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;ORR;DCR;Change rate of target lesion in arterial perfusion blood supply area; | — |
Countries
china
Contacts
Public Contactji jiansong
Lishui Central Hospital of Zhejiang Province
Outcome results
None listed