Carcinoma, HepatocellularPhase 2/3ACTIONNCT01861912
Arsenic Trioxide TACE and Intravenous Administration in Unresectable Hepatocellular Carcinoma
A Phase 2/3 study testing Arsenic trioxide TACE, Arsenic trioxide intravenous infusion and lipiodol in people with Carcinoma, Hepatocellular, run by Guangdong Provincial People's Hospital.
Trial summary
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. 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?
- Arsenic trioxide TACE, Arsenic trioxide intravenous infusion and lipiodol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2016
- Phase
- Phase 2/3
- 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
- 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;
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- 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:
- Neutrophil count≥1.5×109/L, platelet count≥60×109 /L; hemoglobin≥85g/L;
- 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;
- Amylase and lipase≤1.5 times the upper limit of the normal range
- Serum creatinine≤20 g/L
- Prothrombin time international normalized ratio ≤1.7; or prothrombin time≤4seconds above control;
- 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;
Who cannot join
- Disease should be excluded:
- CT / MRI showed diffuse lesions;
- Extrahepatic metastasis (metastasis in lungs not included);
- Invasion in the main portal vein / vena cava or other major vascular;
- Previous shunt surgery;
- PreviousTACE or transarterial embolization for HCC, unless there is a untreated lesion;
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- Hepatic encephalopathy in the past or present;
- Current ascites requiring treatment;
- Medical history and concomitant diseases:
- 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;
- 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：
- Hyponatremia, serum sodium <130 mmol / L；
- 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:
- Condensation treatment (e.g., warfarin or heparin);
- Chronic antiplatelet therapy (Aspirin ≥ 300 mg / day; clopidogrel ≥ 75 mg / day);
- Radiotherapy within 4 weeks;
About this study
Official title: 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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Arsenic trioxide TACE, Arsenic trioxide intravenous infusion, lipiodol, NaCl solution
- Keywords
- Carcinoma, Hepatocellular, Arsenic trioxide
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenic trioxide TACEDevice
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
Arsenic trioxide intravenous infusionDrug
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.
lipiodolDrug
Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.
NaCl solutionDrug
250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Arsenic trioxide TACE | Active comparator | 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. Receives: Device: Arsenic trioxide TACE; Drug: lipiodol |
| Arsenic trioxide TACE+IV | Experimental | 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. Receives: Device: Arsenic trioxide TACE; Drug: Arsenic trioxide intravenous infusion; Drug: lipiodol; Drug: NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
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).
Measured: 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 outcomes (3)
Overall Survival
Overall survival in our study is defined as the time from a patient's enrollment to the time for death.
Measured: 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
Quality of life is assessed according to the FACT-Hep questionnaire.
Measured: 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
Safety of our treatment plan will be assessed according to the Common Terminology Criteria for Adverse Events（CTCAE） 3.0
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (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.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ligong Lu, Guangdong Provincial People's Hospital
- Investigators
- Ligong Lu, Doctor, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861912
- Sponsor's protocol ID
- GDREC2013109H(R1)
- Acronym
- ACTION
- Status last verified
- Jun 2013
- First submitted
- 16 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arsenic Trioxide TACE and Intravenous Administration Compared With Arsenic Trioxide TACE Alone in Unresectable Hepatocellular Carcinoma: a Randomized, Parallel, Controlled, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT01861912
- Acronym / sponsor ID
- ACTION / GDREC2013109H(R1)
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Carcinoma, Hepatocellular, Arsenic trioxide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 May 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arsenic trioxide TACE | Active comparator | Device: Arsenic trioxide TACE, Drug: lipiodolArsenic 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. |
| Arsenic trioxide TACE+IV | Experimental | Device: Arsenic trioxide TACE, Drug: Arsenic trioxide intravenous infusion, Drug: lipiodol, Drug: NaCl solution1. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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；
Key exclusion criteria (20 listed)
- Disease should be excluded:
- Medical history and concomitant diseases:
- (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：
- Allergic reactions to arsenic trioxide and any other drugs used in this trail;
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 |
|---|---|---|
| Arsenic trioxide TACEArsenic 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 TACE+IV |
| Arsenic trioxide intravenous infusionArsenic 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 | Arsenic trioxide TACE+IV |
| lipiodolLipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion. | Drug | Arsenic trioxide TACE, Arsenic trioxide TACE+IV |
| NaCl solution250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion. | Drug | Arsenic trioxide TACE+IV |
Primary outcome
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).
3 secondary outcomes
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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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.
Ligong Lu, Doctor principal investigator
Guangdong Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Arsenic trioxide TACE, Arsenic trioxide intravenous infusion and lipiodol in people with Carcinoma, Hepatocellular, run by Guangdong Provincial People's Hospital.
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 17 inclusion and 20 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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 or date of death from any cause, whichever came first, assessed up to 2 years.). 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 5 Jun 2013.