safety and efficacy of arsenic trioxide contained in tace in the treatment of hcc

Conditions: Carcinoma, Hepatocellular

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.


Eligibility criteria:
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.

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