Carcinoma, Hepatocellular
Conditions
Keywords
Carcinoma, Hepatocellular, primary liver cancer, primary hepatocellular carcinoma, transarterial chemoembolization, Chemoembolization, Therapeutic, arsenic trioxide, arsenous anhydride, diarsenic trioxide, randomized controlled trial, multicenter study, HCC, TACE
Brief summary
The purpose of the study is to determine whether transarterial chemoembolization containing arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular carcinoma.
Interventions
DRUGTACE containing As2O3
transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
DRUGTACE containing placebo
transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
Sponsors
Sun Yat-sen University
Zhongda Hospital
Fudan University
Xijing Hospital
First Hospital of China Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* accordance with primary hepatocellular carcinoma diagnosis standard：cytohistology 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. * age of 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
* concomitant malignancies distinct from HCC currently or previously * allergic to subject agent(such as arsenic) or other agent related to the trial * BCLC stage 0,A,C or D * HCC accounting for the 70% of the liver size or more * liver function Child-Pugh score of C * ECOG score of 1 or higher * 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 β-blockers、calcium channel blockers and digoxin ) * uncontrollable hypertension(diastolic blood pressure cannot be controlled below 90 mmHg even after antihypertension treatment by antihypertensive drugs). * active severe infection(grade 2 or higher according to NCI-CTCAE version 4.0) * active tuberculosis or pulmonary tuberculosis cannot be excluded * CNS malignancies, including intracranial metastases * gastrointestinal bleeding with clinical findings in the previous 30 days * chronic renal failure * pregnancy or breastfeeding * 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 | From date of randomization until the date of first documented progression, up to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | every 3 months from randomization until the date of first documented progression, up to 24 months | patients proportion of CR and PR according to mRECIST |
| progression free survival | From date of randomization until the date of first documented progression, up to 24 months | survival from randomization to the date of first documented progression according to the mRECIST criterion |
| overall survival | From date of randomization until the date of death from any cause, up to 60 months | — |
| Proportion of Participants with Adverse Events | every 3 months from randomization until the date of first documented progression, up to 24 months | — |
Countries
China
Contacts
Primary ContactHaibo Shao, MD,PHD
Outcome results
None listed