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

NCT02018757 | Unknown Phase 2 DMC

• 1 other identifier: 2012AA022701
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

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

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

Outcome Measures

Primary Outcomes (1)

• time to progression

  From date of randomization until the date of first documented progression, up to 24 months

Secondary Outcomes (4)

• objective response rate

  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

• overall survival

  From date of randomization until the date of death from any cause, up to 60 months

• Proportion of Participants with Adverse Events

  every 3 months from randomization until the date of first documented progression, up to 24 months

Study Arms (2)

As2O3

EXPERIMENTAL

Subjects will be treated with TACE containing As2O3

Drug: TACE containing As2O3

placebo

PLACEBO COMPARATOR

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

Drug: TACE containing placebo

Interventions

TACE containing As2O3 DRUG

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

Also known as: transarterial chemoembolization,TACE,As2O3,arsenious acid

As2O3

TACE containing placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Hospital of China Medical University: lead
• Sun Yat-sen University: collaborator
• Zhongda Hospital: collaborator
• Fudan University: collaborator
• Xijing Hospital: collaborator

Study Sites (5)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Xijing Hospital，Fourth Military Medical University

Xi'an, Shaanxi, China

Location

Zhongshan Hospital Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Haibo Shao, MD,PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haibo Shao, MD,PHD

CONTACT

862483282730; haiboshao@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

CN (5)