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

May 25, 2014 updated by: Haibo Shao, First Hospital of China Medical University

Clinical Application Study of Transarterial Chemoembolization Containing Arsenic Trioxide in the Treatment of Hepatocellular Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Zhongshan Hospital Fudan University
        • Principal Investigator:
          • Jianhua Wang, MD,PHD
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen University Cancer Center
        • Principal Investigator:
          • Peihong Wu, MD,PHD
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Zhongda Hospital Southeast University
        • Contact:
          • Gaojun Teng, MD,PhD
        • Principal Investigator:
          • Gaojun Teng, MD,PhD
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
        • Principal Investigator:
          • Haibo Shao, MD,PHD
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Xijing Hospital,Fourth Military Medical University
        • Principal Investigator:
          • Guohong Han, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: As2O3
Subjects will be treated with TACE containing As2O3
Drug: TACE containing As2O3
transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
Other Names:
  • transarterial chemoembolization,TACE,As2O3,arsenious acid
Placebo Comparator: placebo
Subjects will be treated with TACE containing placebo which mimics the arsenic trioxide
Drug: TACE containing placebo
transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to progression
Time Frame: From date of randomization until the date of first documented progression, up to 24 months
From date of randomization until the date of first documented progression, up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: 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
every 3 months from randomization until the date of first documented progression, up to 24 months
progression free survival
Time Frame: 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
From date of randomization until the date of first documented progression, up to 24 months
overall survival
Time Frame: From date of randomization until the date of death from any cause, up to 60 months
From date of randomization until the date of death from any cause, up to 60 months
Proportion of Participants with Adverse Events
Time Frame: every 3 months from randomization until the date of first documented progression, up to 24 months
every 3 months from randomization until the date of first documented progression, up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Collaborators

Xijing Hospital
Sun Yat-sen University
Fudan University
Zhongda Hospital

Investigators

  • Principal Investigator: Haibo Shao, MD,PhD, First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 25, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012AA022701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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