Carcinoma, HepatocellularPhase 2SEATHNCT02018757
Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC
A Phase 2 study testing TACE containing As2O3 in people with Carcinoma, Hepatocellular, run by First Hospital of China Medical University at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- TACE containing As2O3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 5 sitesChina
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Peihong Wu, MD,PHD
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Gaojun Teng, MD,PhD
Gaojun Teng, MD,PhD
Zhongshan Hospital Fudan University
Shanghai
Jianhua Wang, MD,PHD
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Haibo Shao, MD,PHD
Xijing Hospital，Fourth Military Medical University
Xi'an, Shaanxi
Guohong Han, MD,PhD
About this study
Official title: 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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- TACE containing As2O3, TACE containing placebo
- 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
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE containing As2O3Drug
Also called transarterial chemoembolization,TACE,As2O3,arsenious acid
transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
TACE containing placeboDrug
transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
| Study group | Role | What they receive |
|---|---|---|
| As2O3 | Experimental | Subjects will be treated with TACE containing As2O3 Receives: Drug: TACE containing As2O3 |
| placebo | Placebo comparator | Subjects will be treated with TACE containing placebo which mimics the arsenic trioxide Receives: Drug: TACE containing placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to progression
Measured: From date of randomization until the date of first documented progression, up to 24 months
Secondary outcomes (4)
objective response rate
patients proportion of CR and PR according to mRECIST
Measured: every 3 months from randomization until the date of first documented progression, up to 24 months
progression free survival
survival from randomization to the date of first documented progression according to the mRECIST criterion
Measured: From date of randomization until the date of first documented progression, up to 24 months
overall survival
Measured: From date of randomization until the date of death from any cause, up to 60 months
Proportion of Participants with Adverse Events
Measured: every 3 months from randomization until the date of first documented progression, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Zhongda Hospital, Fudan University, Xijing Hospital
- Responsible party
- Principal investigator, Haibo Shao, First Hospital of China Medical University
- Investigators
- Haibo Shao, MD,PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018757
- Sponsor's protocol ID
- 2012AA022701
- Acronym
- SEATH
- Status last verified
- May 2014
- First submitted
- 9 Dec 2013
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Study of Transarterial Chemoembolization Containing Arsenic Trioxide in the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02018757
- Acronym / sponsor ID
- SEATH / 2012AA022701
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Carcinoma, Hepatocellular, primary liver cancer, primary hepatocellular carcinoma, transarterial chemoembolization, Chemoembolization, Therapeutic, arsenic trioxide, arsenous anhydride, diarsenic trioxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Zhongda Hospital, Fudan University, Xijing Hospital
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| As2O3 | Experimental | Drug: TACE containing As2O3Subjects will be treated with TACE containing As2O3 |
| placebo | Placebo comparator | Drug: TACE containing placeboSubjects will be treated with TACE containing placebo which mimics the arsenic trioxide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE containing As2O3Also: transarterial chemoembolization,TACE,As2O3,arsenious acidtransarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol | Drug | As2O3 |
| TACE containing placebotransarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol | Drug | placebo |
Primary outcome
time to progression
Time frame: From date of randomization until the date of first documented progression, up to 24 months
4 secondary outcomes
objective response rate
Time frame: 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
overall survival
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haibo Shao, MD,PhD principal investigator
First Hospital of China Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TACE containing As2O3 in people with Carcinoma, Hepatocellular, run by First Hospital of China Medical University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haibo Shao, MD,PHD (862483282730, haiboshao@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to progression (time frame: From date of randomization until the date of first documented progression, up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.