Hepatocellular CarcinomaNCT01857726
Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
A study testing Doxorubicin and Cisplatin in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Doxorubicin and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
- Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI
- Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible
- Age : 18 years to 80 years
- ECOG Performance Status of 0 to 2
- Child-Pugh class A (Child-Pugh score 5-6)
Show all 13Show fewer
- Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- WBC count > 2,000/mm3
- Absolute neutrophil count > 1,000/mm3
- Hb ≧ 8.0 g/dL
- Platelet count ≧ 50,000 /mm3
- Bilirubin ≦ 3 mg/dL
- Adequate clotting function: INR < 2.3 or < 6sec
Who cannot join
- Child-Pugh score ≧ 7
- ECOG Performance Status ≧ 3
- Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
- History of organ allograft
- Patients with uncontrolled co-morbidity which needs treatment
- Patients who have received prior systemic chemotherapy
- Patients with extrahepatic metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.
Read the detailed description
Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.
However, HCC patients are diagnosed at advanced stages in Korea. Especially, HCCs with portal vein invasion are unresectable and they are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients.
The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Doxorubicin, Cisplatin
- Keywords
- hepatocellular carcinoma, portal vein invasion, transarterial chemoembolization, transarterial chemoinfusion
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Adriamycin
Transarterial chemoembolization (TACE) with adriamycin
CisplatinDrug
transarterial chemoinfusion with cisplatin 50-100 mg
| Study group | Role | What they receive |
|---|---|---|
| The TACE/TACI combination group | Experimental | Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination Receives: Drug: Doxorubicin; Drug: Cisplatin |
| The TACE-only group | Active comparator | Transarterial chemoembolization with doxorubicin Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: every 12 weeks, up to 48 weeks
Secondary outcomes (2)
Time-to-progression
Measured: every 12 weeks, up to 48 weeks
Progression-free survival
Measured: every 12 weeks, up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: No participants were enrolled
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Hwan Yoon, Seoul National University Hospital
- Investigators
- Jung-Hwan Yoon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857726
- Sponsor's protocol ID
- PVT_TACE/TACI
- Status last verified
- Apr 2016
- First submitted
- 13 May 2013
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
- ClinicalTrials.gov ID
- NCT01857726
- Acronym / sponsor ID
- PVT_TACE/TACI
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, portal vein invasion, transarterial chemoembolization, transarterial chemoinfusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 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 aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.
Detailed description
Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.
However, HCC patients are diagnosed at advanced stages in Korea. Especially, HCCs with portal vein invasion are unresectable and they are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients.
The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with 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 |
|---|---|---|
| The TACE/TACI combination group | Experimental | Drug: Doxorubicin, Drug: CisplatinTransarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination |
| The TACE-only group | Active comparator | Drug: DoxorubicinTransarterial chemoembolization with doxorubicin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
- Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI
- Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible
- Age : 18 years to 80 years
- ECOG Performance Status of 0 to 2
Key exclusion criteria (7 listed)
- Child-Pugh score ≧ 7
- ECOG Performance Status ≧ 3
- Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
- History of organ allograft
- Patients with uncontrolled co-morbidity which needs treatment
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 |
|---|---|---|
| DoxorubicinAlso: AdriamycinTransarterial chemoembolization (TACE) with adriamycin | Drug | The TACE-only group, The TACE/TACI combination group |
| Cisplatintransarterial chemoinfusion with cisplatin 50-100 mg | Drug | The TACE/TACI combination group |
Primary outcome
Overall survival
Time frame: every 12 weeks, up to 48 weeks
2 secondary outcomes
Time-to-progression
Time frame: every 12 weeks, up to 48 weeks
Progression-free survival
Time frame: every 12 weeks, up to 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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 study testing Doxorubicin and Cisplatin 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 7 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: withdrawn, as of the sponsor's last update on 28 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall survival (time frame: every 12 weeks, up to 48 weeks). 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 Apr 2016.