Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC
Phase 2
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Registration Number
- NCT02018757
- Lead Sponsor
- First Hospital of China Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description As2O3 TACE containing As2O3 Subjects will be treated with TACE containing As2O3 placebo TACE containing placebo Subjects will be treated with TACE containing placebo which mimics the arsenic trioxide
- Primary Outcome Measures
Name Time Method time to progression From date of randomization until the date of first documented progression, up to 24 months
- Secondary Outcome Measures
Name Time Method 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
Proportion of Participants with Adverse Events every 3 months from randomization until the date of first documented progression, up to 24 months 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
Trial Locations
- Locations (5)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Xijing Hospital，Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China