arsenic trioxide tace and intravenous administration in unresectable hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: the purpose of this study is to determine whether compared with arsenic trioxide tace alone, arsenic trioxide tace and intravenous administration could further prolong the overall survival.


Eligibility criteria:
inclusion criteria: * having signed informed consent; * histological or clinical diagnosis of hepatocellular carcinoma（hcc）; * the target lesion should had at least one diameter line available for measurement, with the maximum diameter ≥5cm and ≤10cm； * barcelona clinic liver cancer staging b or c; * child-pugh liver function class: score≤7； * eastern cooperative oncology group performance 0 or 1; * at least 12 weeks life expectancy; * never received systemic treatment, such as oral molecularly targeted drugs and systemic chemotherapy; * be able to abide by the treatment and follow-up plan； * adequate results for laboratory tests, including: 1. neutrophil count≥1.5×109/l, platelet count≥60×109 /l; hemoglobin≥85g/l; 2. total bilirubin≤51.3 μmol/l, albumin≥28 g/l,and alanine aminotransferase and aspartate aminotransferase≤5 times the upper limit of the normal range; 3. amylase and lipase≤1.5 times the upper limit of the normal range 4. serum creatinine≤20 g/l 5. prothrombin time international normalized ratio ≤1.7; or prothrombin time≤4seconds above control; 6. left ventricular ejection fraction≥50% according to two-dimensional echocardiography; * contraception: during the trail and 12 weeks after the withdrawal, female of childbearing age (wocbp), wocbp whose male partners receive study drug or male must use appropriate contraceptive to avoid pregnancy; exclusion criteria: * disease should be excluded: 1. ct / mri showed diffuse lesions; 2. extrahepatic metastasis (metastasis in lungs not included); 3. invasion in the main portal vein / vena cava or other major vascular; 4. previous shunt surgery; 5. previoustace or transarterial embolization for hcc, unless there is a untreated lesion; 6. hepatic encephalopathy in the past or present; 7. current ascites requiring treatment; * medical history and concomitant diseases: 1. previous or current cancer other than hcc, unless it is cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta, tis and t1). cancer having received curative treatment 5 years ago will not be excluded; 2. disease history in the cardiovascular system as the following: (a)uncontrolled hypertension；(b)congestive heart failure in new york heart association grade 3 or 4; (c)active coronary artery disease within 12 months, unstable angina or newly diagnosed angina/myocardial infarction;(d)arrhythmia requiring drugs other than β-blockers and digoxin;(e)valvular heart disease ≥ ctcae grade 2； c) corrected qt interval (fridericia)\> 450 ms confirmed by 2 ecgs in a row d) thrombotic or embolic events within 6 months, e) gastrointestinal bleeding within 6 months; f) unstable and / or active stomach ulcer within 6 months, unless gastroscopy showed it to be fully recovered; g) variceal bleeding within 6 months; h) unhealed wound or ulcer, fracture within 3 months; i) major surgery, open biopsy, or severe trauma within 3 weeks; j) history of organ transplant or subjects in the transplant waiting list; k) uncontrolled abnormal thyroid function; l) hiv infection; m) active or untreated hepatitis b; * laboratory tests unsuitable for the enrollment： 1. hyponatremia, serum sodium \<130 mmol / l； 2. hypokalemia, serum potassium \<3.5 mmol / l； * allergic reactions to arsenic trioxide and any other drugs used in this trail; * forbidden therapies and/or drugs: 1. condensation treatment (e.g., warfarin or heparin); 2. chronic antiplatelet therapy (aspirin ≥ 300 mg / day; clopidogrel ≥ 75 mg / day); 3. radiotherapy within 4 weeks;

Keywords: carcinoma, hepatocellular arsenic trioxide