Clinical trial NCT02018757: Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC
Official title: Clinical Application Study of Transarterial Chemoembolization Containing Arsenic Trioxide in the Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
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
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Zhongda Hospital
name: Fudan University
name: Xijing Hospital
First posted: 2013-12-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: time to progression
timeFrame: From date of randomization until the date of first documented progression, up to 24 months
Secondary outcomes:
measure: objective response rate
timeFrame: every 3 months from randomization until the date of first documented progression, up to 24 months
measure: progression free survival
timeFrame: From date of randomization until the date of first documented progression, up to 24 months
measure: overall survival
timeFrame: From date of randomization until the date of death from any cause, up to 60 months
measure: Proportion of Participants with Adverse Events
timeFrame: every 3 months from randomization until the date of first documented progression, up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: Xijing Hospital，Fourth Military Medical University
state: Shaanxi
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: First Hospital of China Medical University
name: Haibo Shao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: