Hepato Cellular CarcinomaPhase 4CineDoxoNCT03706157
Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE
A Phase 4 study testing Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media and Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline in people with Hepato Cellular Carcinoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Conventional transarterial chemoembolization with Doxorubicin (c-TACE) is the gold standard treatment for Hepato Cellular Carcinoma (HCC) stage B (BCLC) / stages A and B (Child-Pugh). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato Cellular Carcinoma
- What is being tested?
- Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media and Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2018to 9 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18)
- Informed consent
- CHC Child-Pugh stage A or B, BCLC stage B
- Referred for chemoembolization of a non-surgery-candidate CHC
- Blood test results compatible with cTACE (INR ≤ 1,5, ASAT/ALAT<5N, albumine>2,5g/dl)
Who cannot join
- Contraindication to cTACE, angiography, confocal laser endomicroscopy or liver biopsy Hyperthyroidism
- Contraindication to the use of fluorescein, Ariblastine,Lipiodol, Visipaque, Gelita spon, Avitene
- extra hepatic metastasis
- Subcapsular or exophytic tumor impeding direct percutaneous access through healthy liver tissue
- Waiting list for liver transplant
- Complete portal venous thrombosis or flow inversion
Show all 10Show fewer
- Pregnancy or breast feeding
- Protected major (Guardianship)
- Patient in situation of exclusion (determined by a previous or ongoing study)
- Subject incapacity to understand informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study
Conventional transarterial chemoembolization with Doxorubicin (c-TACE) is the gold standard treatment for Hepato Cellular Carcinoma (HCC) stage B (BCLC) / stages A and B (Child-Pugh). Clinical recommendations for cTACE indicate that the doxorubicin solution may be reconstituted in either aqueous solution or iso-osmolar ionic iodinated contrast media. There is no consensus on which solvent should be used. Hence, the clinical evaluation of Lipiodol cTACE would benefit from a standardization in the reconstitution of the drug. In this study, the comparison of the kinetics of distribution of the drug within the tumor micro-environment is expected to allow for comparison of drug solvents.
This pilot study aims at evaluating the kinetics of distribution of the drug within the tumor micro-environment, for the two main solvents used in reconstituting the drug, namely normal saline and contrast media. The kinetics of distribution in the tumor will be evaluated primarily through regular biopsy sampling, and secondary with confocal laser endomicroscopy.
- Conditions
- Hepato Cellular Carcinoma
- Being tested
- Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media, Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline
- Keywords
- Conventional transarterial chemoembolization (c-TACE), Doxorubicin, Kinetics of distribution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast mediaDrug
Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media
Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal salineDrug
Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline
| Study group | Role | What they receive |
|---|---|---|
| Iodinate contrast | Active comparator | Doxorubicin solution reconstituted in 5 mL iso-osmolar ionic iodinated contrast media Receives: Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media |
| Normal saline | Active comparator | Doxorubicin solution reconstituted in 5 mL normal saline Receives: Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
Measured: T0: 1 min before cTACE drug injection star
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
Measured: T1 : 2 min after cTACE drug injection started
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
Measured: T2: 1 second after half of cTACE drug has been injected
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
Measured: T3: 1 min after cTACE drug injection is completed
Secondary outcomes (4)
In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
Continuous image recording (videos) through the course of the cTACE drug injection, from 1 minute before drug injection starts to the time when cTACE drug injection is completed
Measured: 1 min before cTACE drug injection starts,
In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
Continuous image recording (videos) through the course of the cTACE drug injection, from 1 minute before drug injection starts to the time when cTACE drug injection is completed
Measured: 2 min after cTACE drug injection started,
In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
Continuous image recording (videos) through the course of the cTACE drug injection, from 1 minute before drug injection starts to the time when cTACE drug injection is completed
Measured: 1 second after half of cTACE drug has been injected,
In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
Continuous image recording (videos) through the course of the cTACE drug injection, from 1 minute before drug injection starts to the time when cTACE drug injection is completed
Measured: 1 min after cTACE drug injection is completed,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start26 Nov 2018
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iuian 03 69 55 15 27, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706157
- Sponsor's protocol ID
- 7040
- Other IDs
- 2018-002163-26, 2018
- Acronym
- CineDoxo
- Status last verified
- Aug 2019
- First submitted
- 2 Oct 2018
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinectics of Distribution of Doxorubicin-Lipiodol Emulsion in c-TACE: a Pilot Study
- ClinicalTrials.gov ID
- NCT03706157
- Acronym / sponsor ID
- CineDoxo / 7040
- Conditions
- Hepato Cellular Carcinoma
- Keywords
- Conventional transarterial chemoembolization (c-TACE), Doxorubicin, Kinetics of distribution
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 15 Oct 2018 (actual)
- 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.
Conventional transarterial chemoembolization with Doxorubicin (c-TACE) is the gold standard treatment for Hepato Cellular Carcinoma (HCC) stage B (BCLC) / stages A and B (Child-Pugh). Clinical recommendations for cTACE indicate that the doxorubicin solution may be reconstituted in either aqueous solution or iso-osmolar ionic iodinated contrast media. There is no consensus on which solvent should be used. Hence, the clinical evaluation of Lipiodol cTACE would benefit from a standardization in the reconstitution of the drug. In this study, the comparison of the kinetics of distribution of the drug within the tumor micro-environment is expected to allow for comparison of drug solvents.
This pilot study aims at evaluating the kinetics of distribution of the drug within the tumor micro-environment, for the two main solvents used in reconstituting the drug, namely normal saline and contrast media. The kinetics of distribution in the tumor will be evaluated primarily through regular biopsy sampling, and secondary with confocal laser endomicroscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodinate contrast | Active comparator | Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast mediaDoxorubicin solution reconstituted in 5 mL iso-osmolar ionic iodinated contrast media |
| Normal saline | Active comparator | Drug: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal salineDoxorubicin solution reconstituted in 5 mL normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (>18)
- Informed consent
- CHC Child-Pugh stage A or B, BCLC stage B
- Referred for chemoembolization of a non-surgery-candidate CHC
- Blood test results compatible with cTACE (INR ≤ 1,5, ASAT/ALAT<5N, albumine>2,5g/dl)
Key exclusion criteria (10 listed)
- Contraindication to cTACE, angiography, confocal laser endomicroscopy or liver biopsy Hyperthyroidism
- Contraindication to the use of fluorescein, Ariblastine,Lipiodol, Visipaque, Gelita spon, Avitene
- extra hepatic metastasis
- Subcapsular or exophytic tumor impeding direct percutaneous access through healthy liver tissue
- Waiting list for liver transplant
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 |
|---|---|---|
| Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast mediaSuper selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media | Drug | Iodinate contrast |
| Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal salineSuper selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline | Drug | Normal saline |
Primary outcome
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
Time frame: T0: 1 min before cTACE drug injection star
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
Time frame: T1 : 2 min after cTACE drug injection started
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
Time frame: T2: 1 second after half of cTACE drug has been injected
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution
Time frame: T3: 1 min after cTACE drug injection is completed
Biopsy samples of liver tumor tissue. Histological analysis will provide a quantification of the doxorubicin drug in tumor compartment.
4 secondary outcomes
In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
Time frame: 1 min before cTACE drug injection starts,
In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
Time frame: 2 min after cTACE drug injection started,
In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
Time frame: 1 second after half of cTACE drug has been injected,
In vivo evaluation of the kinetics of distribution of doxorubicine in tumoral tissue with confocal laser endomicroscopy, depending on the solvent used for drug reconstitution
Time frame: 1 min after cTACE drug injection is completed,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Related trials for Hepato Cellular Carcinoma
Not yet recruitingPhase 2
An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable HCC
Hepato Cellular Carcinoma (HCC), Immune Checkpoint Inhibitor
RecruitingPhase 2
TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk
Hepato Cellular Carcinoma (HCC)
RecruitingObservational study
LEOPARD Training and Validation Data Collection Study
Decompensated Liver Cirrhosis, Primary Biliary Cholangitis
Not yet recruitingPhase 4
Ebastine for Adjuvant Treatment of Tumor Budding-Positive Liver Cancer After Surgery
Hepato Cellular Carcinoma
RecruitingObservational study
LEOPARD Prospective Validation Cohort 1
Decompensated Liver Cirrhosis, Primary Biliary Cholangitis
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.
Iuian 03 69 55 15 27, MD principal investigator
University Hospital, Strasbourg, France
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 Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media and Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline in people with Hepato Cellular Carcinoma, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 5 Jun 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histological analysis of biopsy samples for the evaluation of the kinetics of distribution of doxorubicine in tumor compartments depending on the solvent used for drug reconstitution (time frame: T0: 1 min before cTACE drug injection star). The study lists 4 primary outcomes in all. 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 2026.