Tumor
Conditions
Interventions
Experimental group:Oxaliplatin + adriamycin (at least 2 mL) + BM601 lipiodol suspension (3 ml) hepatic artery embolization
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged 18-75 years, with an estimated survival period of more than 3 months; 2. Hepatocellular carcinoma confirmed by histopathology and/or clinical diagnosis; the Chinese clinical stage of liver cancer (CNLC) is stage ?b~?b; 3. General condition score ECOG 0-2 points; 4. There is at least one measurable or evaluable tumor lesion, that is, the longest diameter of the baseline period is >= 3 cm; 5. Patients should have sufficient bone marrow reserve function, or have no liver and kidney coagulation dysfunction, and the laboratory test values ??must meet the following conditions: (1) Absolute neutrophil count > 1.5 × 10^9/L, and white blood cell count > 3 × 10^9/L; (2) Platelet count > 80 × 10^9/L; (3) Hemoglobin > 90 g/L; (4) Serum creatinine 30 mL/min; (5) If there is no confirmed liver metastasis, AST, ALT < 2.5 × ULN; if there is confirmed liver metastasis, AST, ALT < 5 × ULN; (6) Total bilirubin < 3 × ULN; (7) International normalized ratio (INR) < 1.5, and activated partial prothrombin time (APTT) < 1.5 × ULN; 6. The patient has no brain metastases (except for patients with asymptomatic brain metastases, or patients with brain metastases but patients whose condition has been stabilized for more than 4 weeks after treatment); 7. The patient voluntarily signs the informed consent form, and the expected compliance is good.
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to the study drug ingredients or their analogs; 2. The patient has any instability or any other disease or medical condition that may affect its safety or research compliance, any serious or uncontrolled systemic disease, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled Controlled hypertension, severe infection, active peptic ulcer, abnormal immune function, etc.; 3. Cardiovascular and cerebrovascular diseases/symptoms/indications that meet any of the following conditions: (1) Collect ECG QTc > 470 ms after resting for ten minutes (corrected QT interval [corrected by Fridericia formula]), QT interval measurement should be from the beginning of the QRS complex to the end of the T wave); (2) Any clinically important resting ECG abnormality in rhythm, conduction or shape, such as complete left bundle branch block, 2nd and 3rd degree heart block, PR interval > 250 ms, etc. ; (3) Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in first-degree relatives under the age of 40 , or any concomitant drug known to prolong the QT interval; (4) Left ventricular ejection fraction (LVEF) < 50%; (5) Those who have a history of decreased myocardial contractility and have experienced related symptoms within 6 months before the study administration: such as chronic congestive heart failure, pulmonary edema, or decreased cardiac ejection fraction; (6) Those who have a history of acute and chronic cardiovascular and cerebrovascular diseases, and have experienced related symptoms within 6 months before the study administration: such as myocardial infarction, severe or unstable angina, cerebral infarction, cerebral hemorrhage, or transient cerebral ischemia blood attack, etc.; 4. Suffer from other malignant tumors or have a history of other malignant tumors, except those that have been effectively controlled in the past, non-invasive, 5-year-free recurrence and metastasis of skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ and breast duct cancer; 5. There is bile duct invasion; 6. For women of childbearing age (postmenopausal women must have been menopausal for at least 12 months before they are considered infertile), the urine pregnancy test results are positive within 7 days before the intratumoral injection of the study drug; or judged by the investigator, during the study During the period and within 3 months after the last dose of the study drug, those who are willing to become pregnant, breastfeed, or unwilling to use effective contraceptive measures (including male subjects and their female spouses of childbearing age); 7. Within 4 weeks before the first administration of the study drug: (1) Received chemotherapy, biological/targeted drug therapy, immunotherapy and other anti-tumor treatments; (2) have undergone major surgery; (3) Participated in other clinical trials, used or are using other experimental drug treatments (except non-intervention drug clinical trials); 8. Other severe, acute, or chronic clinical or psychiatric diseases or laboratory abnormalities that may increase the risk of research and research medication, or may interfere with research results; 9. Patients with active autoimmune diseases or patients with a history of autoimmune diseases that may relapse, but patients with t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;serious adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| untreatable tumor progression;objective response rate;disease control rate;duration of disease remission;tumor progression free survival;time to disease progression; | — |
Countries
China
Contacts
Public ContactZhao Zhongwei
Lishui Central Hospital
Outcome results
None listed