Hepatocellular CarcinomaPhase 2NCT01480817
Sorafenib VS TACE in HCC Patients With Portal Vein Invasion
A Phase 2 study testing Sorafenib and TACE for HCC with portal vein invasion in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib and TACE for HCC with portal vein invasion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 80 > Age >= 18 years.
- Child-Pugh class A (class B could be included when Childs score is 7).
- Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI
- not only newly diagnosed treatment-naive patients,
- but also HCC patients previously treated with other therapies in case of development of major branch of portal vein invasion
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
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- White blood cell counts (WBC) >= 2,000 /μl, Absolute neutrophil count (ANC) > 1,200/μl
- Hemoglobin >= 8.0 g/dl
- Platelet count > 50,000/μl
- Serum creatinine < 1.7 mg/dl
- Total bilirubin =< 3.0 mg/dl
- Prothrombin Time (PT)-international normalized ratio (INR) =< 2.3 or Prothrombin Time (PT)-sec =< 6 sec
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Who cannot join
- Child-Pugh score >= 8.
- Age < 18 or >= 80 years.
- ECOG Performance Status >= 3.
- Recipient of living donor or deceased donor liver transplantation
- Patients unable to understand the contents of informed consent or refuse to sign the informed consent.
- Patients with evidence of uncontrolled or severe medical conditions requiring treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.
Read the detailed description
TACE is an established therapy for patients with unresectable hepatocellular carcinoma (HCC) and has been shown to significantly improve survival in these patients compared to no treatment. Moreover, TACE can be performed safely and may improve the overall survival of patients with HCC and major branch of portal vein invasion. Sorafenib, already approved for HCC, could lead to significantly improvement in tumor control and survival in patients with advanced stage HCC. So far there are no head to head comparison reports about the efficacy of Sorafenib and TACE. Here the investigators evaluate the efficacy of sorafenib and TACE in advanced HCC with major branch of portal vein invasion.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib, TACE for HCC with portal vein invasion
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
Sorafenib 400mg po bid
TACE for HCC with portal vein invasionProcedure or surgery
Also called TACE
The volume of iodized oil ranged from 2 to 12 mL, and the amount of doxorubicin ranged from 10 to 60 mg. Gelatin sponge particles were mixed with mitomycin and contrast material.Cisplatin was infused at the tumor feeder vessels as a solution with a concentration of 0.5 mg/mL at a rate of 5-10 mL/min. The total amount of cisplatin used ranged from 50 to 100 mg depending on the patient's body weight and the level of infusion.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Active comparator | Sorafenib 400mg po bid Receives: Drug: Sorafenib |
| TACE for HCC with portal vein invasion | Experimental | Antineoplastic agents are directly injected into the hepatic artery, allowing high intratumoral concentrations of drugs and thereby reducing systemic side effects. The mixture of chemotherapeutic agents and iodized oil is almost completely retained in neoplastic nodules and can remain in HCC tissue for a long time. Subsequent mechanical embolization of the artery feeding the neoplasm causes ischemic damage to the tumor and prolongs the duration of the effects of chemotherapeutic agents. Receives: Procedure: TACE for HCC with portal vein invasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression (Efficacy)
Measured: every 6 weeks up to 3 years
Secondary outcomes (7)
overall survival
Measured: every 6 weeks up to 3 years
objective tumor response rate
Determined by dynamic-perfusion CT scan at the end of each cycle
Measured: every 6 weeks up to 3 years
objective tumor control rate
Determined by dynamic-perfusion CT scan at the end of each cycle
Measured: every 6 weeks up to 3 years
progression-free survival
Measured: every 6 weeks up to 3 years
the adverse event rate and examine the toxicities
The investigators will evaluate the adverse event according to Common Toxicity Criteria(version 4.0)by National Cancer Institute of National Institutes of Health
Measured: every 6 weeks up to 3 years
Change of perfusion parameter
Measured: every 6 weeks up to 3 years
Alpha feto protein (AFP) responsiveness
AFP responder : 20% reduction from baseline AFP level after 6 weeks of treatment
Measured: every 6 weeks up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Difficulty of participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Hwan Yoon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480817
- Sponsor's protocol ID
- STAP
- Status last verified
- Dec 2013
- First submitted
- 20 Nov 2011
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
- ClinicalTrials.gov ID
- NCT01480817
- Acronym / sponsor ID
- STAP
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of participant enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Nov 2011 (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 investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.
Detailed description
TACE is an established therapy for patients with unresectable hepatocellular carcinoma (HCC) and has been shown to significantly improve survival in these patients compared to no treatment. Moreover, TACE can be performed safely and may improve the overall survival of patients with HCC and major branch of portal vein invasion. Sorafenib, already approved for HCC, could lead to significantly improvement in tumor control and survival in patients with advanced stage HCC. So far there are no head to head comparison reports about the efficacy of Sorafenib and TACE. Here the investigators evaluate the efficacy of sorafenib and TACE in advanced HCC with major branch of portal vein invasion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Active comparator | Drug: SorafenibSorafenib 400mg po bid |
| TACE for HCC with portal vein invasion | Experimental | Procedure: TACE for HCC with portal vein invasionAntineoplastic agents are directly injected into the hepatic artery, allowing high intratumoral concentrations of drugs and thereby reducing systemic side effects. The mixture of chemotherapeutic agents and iodized oil is almost completely retained in neoplastic nodules and can remain in HCC tissue for a long time. Subsequent mechanical embolization of the artery feeding the neoplasm causes ischemic damage to the tumor and prolongs the duration of the effects of chemotherapeutic agents. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 80 > Age >= 18 years.
- Child-Pugh class A (class B could be included when Childs score is 7).
- Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Key exclusion criteria (6 listed)
- Child-Pugh score >= 8.
- Age < 18 or >= 80 years.
- ECOG Performance Status >= 3.
- Recipient of living donor or deceased donor liver transplantation
- Patients unable to understand the contents of informed consent or refuse to sign the informed consent.
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 |
|---|---|---|
| SorafenibAlso: NexavarSorafenib 400mg po bid | Drug | Sorafenib |
| TACE for HCC with portal vein invasionAlso: TACEThe volume of iodized oil ranged from 2 to 12 mL, and the amount of doxorubicin ranged from 10 to 60 mg. Gelatin sponge particles were mixed with mitomycin and contrast material.Cisplatin was infused at the tumor feeder vessels as a solution with a concentration of 0.5 mg/mL at a rate of 5-10 mL/min. The total amount of cisplatin used ranged from 50 to 100 mg depending on the patient's body weight and the level of infusion. | Procedure or surgery | TACE for HCC with portal vein invasion |
Primary outcome
Time to Progression (Efficacy)
Time frame: every 6 weeks up to 3 years
7 secondary outcomes
overall survival
Time frame: every 6 weeks up to 3 years
objective tumor response rate
Time frame: every 6 weeks up to 3 years
objective tumor control rate
Time frame: every 6 weeks up to 3 years
progression-free survival
Time frame: every 6 weeks up to 3 years
the adverse event rate and examine the toxicities
Time frame: every 6 weeks up to 3 years
Change of perfusion parameter
Time frame: every 6 weeks up to 3 years
Alpha feto protein (AFP) responsiveness
Time frame: every 6 weeks up to 3 years
Results and safety
The study was stopped early (reason given: Difficulty of participant enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
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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.
Jung-Hwan Yoon, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib and TACE for HCC with portal vein invasion in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
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 13 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. 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?
The study was stopped early (reason given: Difficulty of participant enrollment.). 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 (Efficacy) (time frame: every 6 weeks up to 3 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 29 Apr 2016.