Liver Cell Carcinoma Non-resectableDEBDOXNCT01891539
Observational Prospective Study on Chemoembolization With Doxorubicin for Unresectable Hepatocellular Carcinoma
An observational study of Liver Cell Carcinoma Non-resectable, run by International Group of Endovascular Oncology at 1 site in Italy.
Trial summary
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh in women and is the third most common cause of death from cancer worldwide. The overall incidence of HCC remains high in developing countries and is steadily rising in most industrialized countries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cell Carcinoma Non-resectable
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: primary care clinic
Who may be able to join
- Patients with confirmed diagnosis of HCC
- Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient rejects the above treatments
- Multinodular or single nodular tumor more than 5cm
- Hypervascular lesion showing contrast enhancement in the early stage after contrast media injection during CT or MRI.
- At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
- No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct
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- Eastern Cooperative Oncology Group performance status is 0 - 1
- Proper blood, liver, renal, heart functionality
- more than 18 years old
- Expected survival more than 6 months
- Prior written consent
Who cannot join
- Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
- Tumor burden involving more than 50% of the liver
- History of biliary tract repair or endoscopic biliary tract treatment
- Clinically important refractory ascites or pleural fluid
- Any contraindications for hepatic embolization procedures
- Any contraindication for doxorubicin administration
Show all 9Show fewer
- Contrast media allergy contraindicating angiography
- Acute or active cardiac, hepatic or renal diseases
- Pregnant, nursing or childbearing age women and men who are sexually active and don't want to or can't do contraception
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, PU, 61122
Giammaria Fiorentini, MD, +390721364124, giammaria.fiorentini@ospedalimarchenord.it
Giammaria Fiorentini, MD
About this study
Official title: Observational Prospective Study on Chemoembolization Using Doxorubicin Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh in women and is the third most common cause of death from cancer worldwide. The overall incidence of HCC remains high in developing countries and is steadily rising in most industrialized countries.
TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel therapy option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded beads were developed to deliver higher doses of the chemotherapeutic agent and to prolong its permanence within the tumor. The comparison of efficacy and safety of TACE with drug-eluting microspheres in comparison with conventional TACE (cTACE) showed that response and time to progression in the group was significantly higher than that of the cTACE group. TACE with drug-eluting microspheres thus appears to be a feasible and promising approach to the treatment of HCC.
This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
Read the detailed description
This study's purpose is to assess treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
Study Design: Prospective observational study . Primary objective: To collect data on tumor response after administration of drug-eluting microspheres that were preloaded with doxorubicin.
Secondary objectives: To collect data on survival rate, time to progression, tolerability of treatment, number of treatment required to achieve objective response and improvement of quality of life.
Treatment method:
Day -1 Doxorubicin at a dose of 35/50 mg/m2 has been charged onto 2 ml of microspheres at Pharmacy. It is suggested to dissolve Doxorubicin powder with 2 ml of contrast medium. The charging time of microspheres is at least 30 minutes.
Day 0: prehydration, antibiotic prophylaxis and setting up of a therapeutic scheme appropriate for analgesic prophylaxis (3-day duration) as previously reported (17)
Day +1:
Upon admittance to the radiology room, 1 vial of tropisetron (diluted in 100ml of physiological solution) and 1 vial of morphine hydrochloride diluted in 100 ml i.v. are administered by slow drip.
One vial of morphine hydrochloride diluted in 100 ml i.v. to be repeated one hour after the procedure and if necessary also after 6 hours.
Tropisetron i.v. if needed. Intra-arterial premedication (optional) with 1 vial of verapamil diluted in 4 ml of normal saline solution followed by 4 ml of lidocaine.
Tumor Infusion (segment/s with dominant disease) of Doxorubicin at a dose of 35/50 mg/m2 preloaded into 2 ml of 70-150 µm M1 microspheres.
A second tumor infusion is allowed if other lesions are present (daughter tumor), using Doxorubicin at a dose of 35/50 mg/m2 preloaded into 2 ml of 70-150 µm M1 microspheres (following radiologist and oncologist ' s planning of cure).
Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated
Evaluation of response Response is assessed at 30, 90 and 180 days after TACE, monitoring tumor dimension using Chest-abdomen CAT scan with and without contrast medium, and cancer markers (CEA, Carbohydrate Antigen (CA) 19.9) Tumor response is performed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Assessment of quality of life Assessment of quality of life with alliative Performance Scale PPSv2 is performed during the baseline visit and 30, 60 and 180 days after treatment.
- Conditions
- Liver Cell Carcinoma Non-resectable
- Keywords
- Hepatocellular carcinoma, doxorubicin, chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| doxorubicin | Day +1: Lobar Infusion ( lobe with dominant disease) of Doxorubicin preloaded into 2 ml of drug-eluting microspheres. Second lobar infusion of Doxorubicin preloaded into 2 ml of drug eluting microspheres can be administered at the same time contralaterally or in a further TACE Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response
CT scan evaluation according to RECIST 1.1
Measured: 4 months
Secondary outcomes (2)
survival rate
patients alive after 12 months
Measured: one year
time to progression
time from start of therapy to progression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Cell Carcinoma Non-resectableStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- International Group of Endovascular Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giammaria Fiorentini, International Group of Endovascular Oncology
- Investigators
- Giammaria Fiorentini, MD, Principal investigator, International Group of Endovascular Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891539
- Sponsor's protocol ID
- DEBDOX01
- Acronym
- DEBDOX
- Status last verified
- Feb 2019
- First submitted
- 26 Jun 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fiorentini G. A new tool to enhance the efficacy of chemoembolization to treat primary and metastatic hepatic tumors. Expert Opin Drug Deliv. 2011 Apr;8(4):409-13. doi: 10.1517/17425247.2011.565327. Epub 2011 Mar 18.
PubMed 21413909Fiorentini G, Campanini A, Dazzi C, Davitti B, Graziani G, Priori T, Ricci Bitti R, Angelini L. Chemoembolization in liver malignant involvement. Experiences on 17 cases. Minerva Chir. 1994 Apr;49(4):281-5.
PubMed 8072703
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study on Chemoembolization Using Doxorubicin Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01891539
- Acronym / sponsor ID
- DEBDOX / DEBDOX01
- Conditions
- Liver Cell Carcinoma Non-resectable
- Keywords
- Hepatocellular carcinoma, doxorubicin, chemoembolization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Group of Endovascular OncologyUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Jul 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.
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh in women and is the third most common cause of death from cancer worldwide. The overall incidence of HCC remains high in developing countries and is steadily rising in most industrialized countries.
TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel therapy option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded beads were developed to deliver higher doses of the chemotherapeutic agent and to prolong its permanence within the tumor. The comparison of efficacy and safety of TACE with drug-eluting microspheres in comparison with conventional TACE (cTACE) showed that response and time to progression in the group was significantly higher than that of the cTACE group. TACE with drug-eluting microspheres thus appears to be a feasible and promising approach to the treatment of HCC.
This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
Detailed description
This study's purpose is to assess treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
Study Design: Prospective observational study . Primary objective: To collect data on tumor response after administration of drug-eluting microspheres that were preloaded with doxorubicin.
Secondary objectives: To collect data on survival rate, time to progression, tolerability of treatment, number of treatment required to achieve objective response and improvement of quality of life.
Treatment method:
Day -1 Doxorubicin at a dose of 35/50 mg/m2 has been charged onto 2 ml of microspheres at Pharmacy. It is suggested to dissolve Doxorubicin powder with 2 ml of contrast medium. The charging time of microspheres is at least 30 minutes.
Day 0: prehydration, antibiotic prophylaxis and setting up of a therapeutic scheme appropriate for analgesic prophylaxis (3-day duration) as previously reported (17)
Day +1:
Upon admittance to the radiology room, 1 vial of tropisetron (diluted in 100ml of physiological solution) and 1 vial of morphine hydrochloride diluted in 100 ml i.v. are administered by slow drip.
One vial of morphine hydrochloride diluted in 100 ml i.v. to be repeated one hour after the procedure and if necessary also after 6 hours.
Tropisetron i.v. if needed. Intra-arterial premedication (optional) with 1 vial of verapamil diluted in 4 ml of normal saline solution followed by 4 ml of lidocaine.
Tumor Infusion (segment/s with dominant disease) of Doxorubicin at a dose of 35/50 mg/m2 preloaded into 2 ml of 70-150 µm M1 microspheres.
A second tumor infusion is allowed if other lesions are present (daughter tumor), using Doxorubicin at a dose of 35/50 mg/m2 preloaded into 2 ml of 70-150 µm M1 microspheres (following radiologist and oncologist ' s planning of cure).
Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated
Evaluation of response Response is assessed at 30, 90 and 180 days after TACE, monitoring tumor dimension using Chest-abdomen CAT scan with and without contrast medium, and cancer markers (CEA, Carbohydrate Antigen (CA) 19.9) Tumor response is performed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Assessment of quality of life Assessment of quality of life with alliative Performance Scale PPSv2 is performed during the baseline visit and 30, 60 and 180 days after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| doxorubicin | – | –Day +1: Lobar Infusion ( lobe with dominant disease) of Doxorubicin preloaded into 2 ml of drug-eluting microspheres. Second lobar infusion of Doxorubicin preloaded into 2 ml of drug eluting microspheres can be administered at the same time contralaterally or in a further TACE Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (11 listed)
- Patients with confirmed diagnosis of HCC
- Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient rejects the above treatments
- Multinodular or single nodular tumor more than 5cm
- Hypervascular lesion showing contrast enhancement in the early stage after contrast media injection during CT or MRI.
- At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
Key exclusion criteria (9 listed)
- Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
- Tumor burden involving more than 50% of the liver
- History of biliary tract repair or endoscopic biliary tract treatment
- Clinically important refractory ascites or pleural fluid
- Any contraindications for hepatic embolization procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tumor response
Time frame: 4 months
CT scan evaluation according to RECIST 1.1
2 secondary outcomes
survival rate
Time frame: one year
time to progression
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Results publication: PubMed 21413909Fiorentini G. A new tool to enhance the efficacy of chemoembolization to treat primary and metastatic hepatic tumors. Expert Opin Drug Deliv. 2011 Apr;8(4):409-13. doi: 10.1517/17425247.2011.565327. Epub 2011 Mar 18.
- Results publication: PubMed 8072703Fiorentini G, Campanini A, Dazzi C, Davitti B, Graziani G, Priori T, Ricci Bitti R, Angelini L. Chemoembolization in liver malignant involvement. Experiences on 17 cases. Minerva Chir. 1994 Apr;49(4):281-5.
- International group of endovascular oncology (IGEVO) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Giammaria Fiorentini, MD principal investigator
International Group of Endovascular Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cell Carcinoma Non-resectable, run by International Group of Endovascular Oncology at 1 site in Italy.
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 11 inclusion and 9 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 27 Feb 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donatella Sarti, PhD (+39072136 ext. 4018, igevo.datamanager@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01891539, which also lists 2 linked publications.
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 27 Feb 2019; AzTrials last refreshed its copy on 3 Nov 2026.