primary liver cancer(primary hepatocellular carcinoma)
Conditions
Interventions
As2O3:transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
placebo:transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the primary hepatocellular carcinoma diagnosis standardcytohistology standard or non-invasive standard: 1)+2)a or 1)+2) b+3) of the following are the non-invasive diagnosis criteria: (1) patients with HBV or HCV related liver cirrhosis; (2) radiological lesion(s) in liver with arterial hypervascularity and venous or delayed phase washout: a. one kind of imaging technology diagnosis for those with lesions>2cm; b. two kinds of imaging technology obtains the consistent conclusion for lesions with diameter of 1-2 cm. (3) serum AFP level =400 ug/L lasting for more than 1 month or =200 ug/L lasting for more than 2 months, other diseases that may cause the AFP level increase can be excluded, such as pregnancy, genital or embryonic tumors and active hepatitis. - aged 18 to 75 year,male or female; - life expectancy of 12 weeks; - Barcelona Clinic Liver Cancer (BCLC)stage B; - laboratory tests: (1) leukocyte>3*19^9/L; (2) hemoglobin=8.5g/dl; (3) platelet count =50*10^9/L; (4) ALT and AST were less than three times the normal limit; (5) albumin = 3.0 g/dl; (6) total bilirubin acuities 3 mg/dl; (7) prothrombin time international standardization ratio (PT - INR) < = 2.3 or prothrombin time (PT)more than normal compared 3 seconds; (8) serum creatinine is less than 1.5 times the normal of the upper limit; - patients with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. concomitant malignancies distinct from HCC currently or previously; 2. allergic to subject agent(such as arsenic) or other agent related to the trial; 3. BCLC stage 0, A, C or D; 4. HCC accounting for the 70% of the liver size or more; 5. liver function Child-Pugh score of C; 6. ECOG score of 1 or higher; 7. severe heart diseases, such as congestive heart failure with cardiac function of New York Heart Association(NYHA)functional class II or severe, active coronary disease(except for who with myocardial infarction for more than 6 months) and cardiac arrhythmia needing medical management(except for that controllable by ß-blockerscalcium channel blockers and digoxin); 8. uncontrollable hypertension(diastolic blood pressure cannot be controlled below 90 mmHg even after antihypertension treatment by antihypertensive drugs); 9. active severe infection(grade 2 or higher according to NCI-CTCAE version 4.0); 10. active tuberculosis or pulmonary tuberculosis cannot be excluded; 11. CNS malignancies, including intracranial metastases; 12. gastrointestinal bleeding with clinical findings in the previous 30 days; 13. chronic renal failure; 14. pregnancy or breastfeeding; 15. any other unstable conditions or circumstances possibly to jeopardise the safety or compliance of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression free survival;overall survival; | — |
Countries
China
Contacts
Public ContactHaibo Shao
The First Hospital of China Medical University
Outcome results
None listed