Hepatocellular CarcinomaPhase 4NCT02525380
Safety and Efficacy of Doxorubicin-eluting-bead Embolization in Patients With Advanced Hepatocellular Carcinoma
A Phase 4 study testing Device(DC Bead) in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Safety and efficacy of doxorubicin-eluting-bead embolization in patients with advanced hepatocellular carcinoma. 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?
- Device(DC Bead)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Aug 2018
- Phase
- Phase 4
- 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
None listed.
Who cannot join
- A history of receiving any systemic therapy of the molecularly targeted agents, immunotherapy or cytotoxic chemotherapy for the treatment of HCC
- Invasion of inferior vena cava (Vv3), or invasion of first order branch of the biliary duct (B3)
- History or presence of hepatic encephalopathy
- Ascites, moderate, large or intractable
- Active clinically serious infections (> grade 2, NCI-CTC version 4.0), including spontaneous bacterial peritonitis.
- Untreated active chronic hepatitis B
Show all 20Show fewer
- Esophageal or gastric varices≥ F2 (grade 2) with red color sign positive without prophylaxis (non-selective beta-blocker or endoscopic variceal ligation) or history of variceal bleeding without endoscopic variceal ligation/ injection sclerosis
- Active ulcer of stomach or duodenum: untreated or presence of visible vessel
- Any major surgery within 4 weeks, or any minor surgery within 2 weeks prior to signing the informed consent form
- Candidate for liver transplant and a history of liver transplantation
- History of cardiac disease: congestive heart failure greater than NYHA class 2; active coronary artery disease; cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension and diabetes mellitus
- History of AIDS/HIV infection.
- Seizure disorder requiring medication.
- History of organ allograft.
- Evidence or history of bleeding diathesis, or thromboembolic events requiring treatment
- Current renal dialysis.
- Previous or concurrent cancer that has a primary site or histology distinct from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis, and T1] or any cancer curatively treated less than 3 years prior to enrollment.
- History of alcohol abuse (male > 210g/week, female >140g/week)
- Any contraindication for chemoembolization except major branch of portal vein invasion
- Any contraindication for doxorubicin administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase4, to Assess Time to Progression (TTP) and Safety Profile of Doxorubicin-Eluting-Bead Embolization(DEBDOX) in Patients With Advanced HCC
Safety and efficacy of doxorubicin-eluting-bead embolization in patients with advanced hepatocellular carcinoma.
Read the detailed description
Transarterial chemoembolization (TACE) represents a first-line non-curative therapy for hepatocellular carcinoma (HCC). TACE is associated with unsatisfactory long-term outcomes. The objective response rate of TACE is only 15% to 55%, and the tumor recurrence rate is 70% at 5 years. One potential reason for this may be the increase in plasma vascular endothelial growth factor (VEGF) levels after TACE. Disturbances in the tumor microenvironment following TACE result in increased hypoxia, leading to an up-regulation in hypoxia inducible factor-1a, which in turn up-regulates VEGF and platelet-derived growth factor receptor (PDGFR) and increases tumor angiogenesis. TACE is considered for the patients with unresectable HCCs that are also ineligible for local ablative therapy. The lack of portal blood flow (because of portal vein thrombosis, portosystemic anastomoses or hepatofugal flow) had been considered as the main contraindication of TACE. However, it has been reported that TACE can be safely performed in a selected population of patients with main portal vein invasion, if they have well-preserved liver function due to collateral blood supply.
DC Beads are a novel drug delivery embolization system comprised of biocompatible, non-resorbable polyvinyl alcohol polymer hydrogel beads which can be loaded with cytotoxic drugs. The beads have a high affinity for drugs and this enables the gradual release of doxorubicin into the tumor, allowing a longer intratumoral exposure and less systemic exposure of the drug, reducing systemic toxicity. One multivariate analysis study showed that the median survival duration for the patients with portal vein invasion who were treated with DC-bead TACE (DEBDOX) were 176 days, retrospectively.
In international, multicenter, randomized phase II trial, the drug-eluting bead group showed higher rates of complete response and objective response compared with the cTACE group (27% vs. 22%, 52% vs. 44% respectively). The hypothesis of superiority was not met. However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response compared to cTACE.
Here, the investigators will investigate the safety and efficacy of DC Bead TACE in patients with advanced HCC with portal vein invasion.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Device(DC Bead)
- Keywords
- Transarterial chemoembolization, Doxorubicin-Eluting-Bead Embolization, DC Bead TACE, Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device(DC Bead)Procedure or surgery
Doxorubicin-Eluting-Bead Embolization (DEBDOX), DC Bead are a novel drug delivery embolization system
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin loadeing-DC Bead(Device) | Experimental | DC Bead comprises hydrogel microspheres that are biocompatible, hydrophilic, non resorbable, precisely calibrated and capable of loading doxorubicin.
DC Bead is produced from polyvinyl alcohol. Receives: Procedure: Device(DC Bead) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Time to progression of hepatocellular carcinoma 30 patients.
The rate of Time to progression of doxorubicin eluting bead embolization in patients with advanced hepatocellular carcinoma.After the treatment period, patients will undergo follow up for safety within 30 days (+7 days) of final DEBDOX, and will undergo follow up for survival every 84 days (±14 days) (84 days is the day counted from the DEBDOX TACE) for at least 3 years.
Measured: up to at least 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2017
- Study completionAug 2018 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BTG International Inc.
- Responsible party
- Principal investigator, Yoon Jun Kim, Seoul National University Hospital
- Investigators
- Yoon Jun Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525380
- Sponsor's protocol ID
- DCbead_PVTT
- Status last verified
- Jan 2018
- First submitted
- 29 Jul 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase4, to Assess Time to Progression (TTP) and Safety Profile of Doxorubicin-Eluting-Bead Embolization(DEBDOX) in Patients With Advanced HCC
- ClinicalTrials.gov ID
- NCT02525380
- Acronym / sponsor ID
- DCbead_PVTT
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Transarterial chemoembolization, Doxorubicin-Eluting-Bead Embolization, DC Bead TACE, Hepatocellular carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- BTG International Inc.
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Aug 2018 (estimated)
- First posted
- 17 Aug 2015 (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.
Safety and efficacy of doxorubicin-eluting-bead embolization in patients with advanced hepatocellular carcinoma.
Detailed description
Transarterial chemoembolization (TACE) represents a first-line non-curative therapy for hepatocellular carcinoma (HCC). TACE is associated with unsatisfactory long-term outcomes. The objective response rate of TACE is only 15% to 55%, and the tumor recurrence rate is 70% at 5 years. One potential reason for this may be the increase in plasma vascular endothelial growth factor (VEGF) levels after TACE. Disturbances in the tumor microenvironment following TACE result in increased hypoxia, leading to an up-regulation in hypoxia inducible factor-1a, which in turn up-regulates VEGF and platelet-derived growth factor receptor (PDGFR) and increases tumor angiogenesis. TACE is considered for the patients with unresectable HCCs that are also ineligible for local ablative therapy. The lack of portal blood flow (because of portal vein thrombosis, portosystemic anastomoses or hepatofugal flow) had been considered as the main contraindication of TACE. However, it has been reported that TACE can be safely performed in a selected population of patients with main portal vein invasion, if they have well-preserved liver function due to collateral blood supply.
DC Beads are a novel drug delivery embolization system comprised of biocompatible, non-resorbable polyvinyl alcohol polymer hydrogel beads which can be loaded with cytotoxic drugs. The beads have a high affinity for drugs and this enables the gradual release of doxorubicin into the tumor, allowing a longer intratumoral exposure and less systemic exposure of the drug, reducing systemic toxicity. One multivariate analysis study showed that the median survival duration for the patients with portal vein invasion who were treated with DC-bead TACE (DEBDOX) were 176 days, retrospectively.
In international, multicenter, randomized phase II trial, the drug-eluting bead group showed higher rates of complete response and objective response compared with the cTACE group (27% vs. 22%, 52% vs. 44% respectively). The hypothesis of superiority was not met. However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response compared to cTACE.
Here, the investigators will investigate the safety and efficacy of DC Bead TACE in patients with advanced HCC with portal vein invasion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin loadeing-DC Bead(Device) | Experimental | Procedure: Device(DC Bead)DC Bead comprises hydrogel microspheres that are biocompatible, hydrophilic, non resorbable, precisely calibrated and capable of loading doxorubicin. DC Bead is produced from polyvinyl alcohol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- A history of receiving any systemic therapy of the molecularly targeted agents, immunotherapy or cytotoxic chemotherapy for the treatment of HCC
- Invasion of inferior vena cava (Vv3), or invasion of first order branch of the biliary duct (B3)
- History or presence of hepatic encephalopathy
- Ascites, moderate, large or intractable
- Active clinically serious infections (> grade 2, NCI-CTC version 4.0), including spontaneous bacterial peritonitis.
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 |
|---|---|---|
| Device(DC Bead)Doxorubicin-Eluting-Bead Embolization (DEBDOX), DC Bead are a novel drug delivery embolization system | Procedure or surgery | Doxorubicin loadeing-DC Bead(Device) |
Primary outcome
The rate of Time to progression of hepatocellular carcinoma 30 patients.
Time frame: up to at least 3 years
The rate of Time to progression of doxorubicin eluting bead embolization in patients with advanced hepatocellular carcinoma.After the treatment period, patients will undergo follow up for safety within 30 days (+7 days) of final DEBDOX, and will undergo follow up for survival every 84 days (±14 days) (84 days is the day counted from the DEBDOX TACE) for at least 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
Yoon Jun Kim, MD, PhD 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 4 study testing Device(DC Bead) 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 0 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 17 Jan 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The rate of Time to progression of hepatocellular carcinoma 30 patients. (time frame: up to at least 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 17 Jan 2018.