Arsenic Trioxide TACE and Intravenous Administration in Unresectable Hepatocellular Carcinoma (ACTION)

June 4, 2013 updated by: Ligong Lu, Guangdong Provincial People's Hospital

Arsenic Trioxide TACE and Intravenous Administration Compared With Arsenic Trioxide TACE Alone in Unresectable Hepatocellular Carcinoma: a Randomized, Parallel, Controlled, Multi-center Clinical Study

The purpose of this study is to determine whether compared with arsenic trioxide TACE alone, arsenic trioxide TACE and intravenous administration could further prolong the overall survival.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

258

Phase

  • Phase 2
  • Phase 3

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:

  • Having signed informed consent;
  • Histological or clinical diagnosis of hepatocellular carcinoma（HCC）;
  • The target lesion should had at least one diameter line available for measurement, with the maximum diameter ≥5cm and ≤10cm；
  • Barcelona Clinic Liver Cancer staging B or C;
  • Child-Pugh liver function class: score≤7；
  • Eastern Cooperative Oncology Group performance 0 or 1;
  • At least 12 weeks life expectancy;
  • Never received systemic treatment, such as oral molecularly targeted drugs and systemic chemotherapy;
  • Be able to abide by the treatment and follow-up plan；

  • Adequate results for laboratory tests, including:

    1. Neutrophil count≥1.5×109/L, platelet count≥60×109 /L; hemoglobin≥85g/L;
    2. Total bilirubin≤51.3 μmol/L, albumin≥28 g/L,and alanine aminotransferase and aspartate aminotransferase≤5 times the upper limit of the normal range;
    3. Amylase and lipase≤1.5 times the upper limit of the normal range
    4. Serum creatinine≤20 g/L
    5. Prothrombin time international normalized ratio ≤1.7; or prothrombin time≤4seconds above control;
    6. Left ventricular ejection fraction≥50% according to two-dimensional echocardiography;
  • Contraception: during the trail and 12 weeks after the withdrawal, female of childbearing age (WOCBP), WOCBP whose male partners receive study drug or male must use appropriate contraceptive to avoid pregnancy;

Exclusion Criteria:

  • Disease should be excluded:

    1. CT / MRI showed diffuse lesions;
    2. Extrahepatic metastasis (metastasis in lungs not included);
    3. Invasion in the main portal vein / vena cava or other major vascular;
    4. Previous shunt surgery;
    5. PreviousTACE or transarterial embolization for HCC, unless there is a untreated lesion;
    6. Hepatic encephalopathy in the past or present;
    7. Current ascites requiring treatment;

  • Medical history and concomitant diseases:

    1. Previous or current cancer other than HCC, unless it is cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1). Cancer having received curative treatment 5 years ago will not be excluded;
    2. Disease history in the cardiovascular system as the following:

    (a)Uncontrolled hypertension；(b)Congestive heart failure in New York Heart Association grade 3 or 4; (c)Active coronary artery disease within 12 months, unstable angina or newly diagnosed angina/myocardial infarction;(d)Arrhythmia requiring drugs other than β-blockers and digoxin;(e)Valvular heart disease ≥ CTCAE grade 2； c) Corrected QT interval (Fridericia)> 450 ms confirmed by 2 ECGs in a row d) Thrombotic or embolic events within 6 months, e) Gastrointestinal bleeding within 6 months; f) Unstable and / or active stomach ulcer within 6 months, unless gastroscopy showed it to be fully recovered; g) Variceal bleeding within 6 months; h) Unhealed wound or ulcer, fracture within 3 months; i) Major surgery, open biopsy, or severe trauma within 3 weeks; j) History of organ transplant or subjects in the transplant waiting list; k) Uncontrolled abnormal thyroid function; l) HIV infection; m) Active or untreated hepatitis B;

  • laboratory tests unsuitable for the enrollment：

    1. Hyponatremia, serum sodium <130 mmol / L；
    2. Hypokalemia, serum potassium <3.5 mmol / L；
  • Allergic reactions to arsenic trioxide and any other drugs used in this trail;

  • Forbidden therapies and/or drugs:

    1. Condensation treatment (e.g., warfarin or heparin);
    2. Chronic antiplatelet therapy (Aspirin ≥ 300 mg / day; clopidogrel ≥ 75 mg / day);
    3. Radiotherapy within 4 weeks;

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arsenic trioxide TACE
Arsenic trioxide TACE: arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4~6 weeks if it is necessary according to the assessment from imaging modalities.
Device: Arsenic trioxide TACE
Arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4~6 weeks if it is necessary according to the assessment from imaging modalities
Drug: lipiodol
Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.
Experimental: Arsenic trioxide TACE+IV
  1. Arsenic trioxide TACE: arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4~6 weeks if it is necessary according to the assessment from imaging modalities.
  2. Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9% sodium chloride solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7~14 days after TACE.
Device: Arsenic trioxide TACE
Arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4~6 weeks if it is necessary according to the assessment from imaging modalities
Drug: lipiodol
Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.
Drug: Arsenic trioxide intravenous infusion
Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9%NaCl solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7~14 days after TACE.
Drug: NaCl solution
250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Progression
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Time to progression in our study is defined as the time from a patient's enrollment to the time for disease progression (according to Recist1.1).
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Overall survival in our study is defined as the time from a patient's enrollment to the time for death.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Quality of Life
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Quality of life is assessed according to the FACT-Hep questionnaire.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Safety
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Safety of our treatment plan will be assessed according to the Common Terminology Criteria for Adverse Events（CTCAE） 3.0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extrahepatic Metastasis Rate
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Extrahepatic metastasis rate is defined as the proportion of the extrahepatic metastasis for patients who were absent of extrahepatic metastasis at enrollment.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Recurrence Rate
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Recurrence rate is defined as the proportion of the recurrence in the patients.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

Collaborators and Investigators

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

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Ligong Lu, Doctor, Guangdong Provincial People's Hospital

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

June 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDREC2013109H(R1)

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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