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

NCT ID: NCT02018757

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

As2O3

Subjects will be treated with TACE containing As2O3

Group Type: EXPERIMENTAL

TACE containing As2O3

Intervention Type: DRUG

transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol

placebo

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

Group Type: PLACEBO_COMPARATOR

TACE containing placebo

Intervention Type: DRUG

transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol

Interventions

TACE containing As2O3

transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol

Intervention Type: DRUG

TACE containing placebo

transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol

Intervention Type: DRUG

Other Intervention Names

transarterial chemoembolization,TACE,As2O3,arsenious acid

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Zhongda Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Haibo Shao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haibo Shao, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

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

Countries

China

Central Contacts

Haibo Shao, MD,PHD

Role: CONTACT

haiboshao@aliyun.com

862483282730

Facility Contacts

Gaojun Teng, MD,PhD

Role: primary

Other Identifiers

2012AA022701

Identifier Type: -

Identifier Source: org_study_id