Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC (SEATH)

China Medical University

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: TACE containing As2O3; Drug: TACE containing placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02018757

2012AA022701

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

250 participants in 2 patient groups, including a placebo group

As2O3

Experimental group

Description:

Subjects will be treated with TACE containing As2O3

Treatment:

Drug: TACE containing As2O3

placebo

Placebo Comparator group

Description:

Subjects will be treated with TACE containing placebo which mimics the arsenic trioxide

Treatment:

Drug: TACE containing placebo