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Hepatocellular CarcinomaPhase 2LIDA-ADJNCT04178642

The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol

A Phase 2 study testing percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment and Percutaneous destruction of the tumor in people with Hepatocellular Carcinoma, run by University Hospital, Montpellier at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim of this study is to test whether the realization of 3 courses of intra-arterial chemotherapy of idarubicin-lipiodol without embolization, administered non-selectively in the hepatic artery, following the percutaneous tumour ablation of a hepatocellular carcinoma, could constitute an effective adjuvant… 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?
percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment and Percutaneous destruction of the tumor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
22 Sep 2020to 14 Jul 2021
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age above 18 and under 80 years-old
  • Chronic or histologically proven stage F3 or F4 hepatopathy, with liver hardness ≥ 10 kPa, or with imaging morphology suggestive of cirrhosis or portal hypertension
  • Child-Pugh score ≤ B7
  • Patients whose biological parameters meet the following criteria:
  • Platelets > 50,000 / mm3
  • Neutrophils > 1000 / mm3
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  • Prothrombin ratio > 50%
  • Creatinemia < 150 μmol / L
  • Total bilirubinemia < 5 mg / dL
  • α-fetoprotein < 200 ng / mL
  • Performance level of 0 or 1 according to "World Health Organization Performance Status"
  • Presence of a single hepatocellular carcinoma of less than 3 cm with typical imaging characteristics as recommended by the American Association for the Study of Liver Diseases (AASLD)
  • Patient with an indication of percutaneous tumor ablation (radiofrequency or microwave) under ultrasound or tomodensitometric identification
  • Absence of heart failure (Left Ventricular Ejection Fraction (LVEF) > 50%)
  • Women of childbearing age, using an effective method of contraception for the duration of treatment and at least 3 months after stopping the treatment.
  • Male using an effective method of contraception throughout the treatment and at least 3 months after stopping the treatment

Who cannot join

  • Presence on the initial imaging assessment of a macroscopic vascular invasion (portal or hepatic vein)
  • Presence on initial imaging assessment of extrahepatic localization of hepatocellular carcinoma
  • Presence of another untreated cancer
  • Patients who previsouly received sphincterotomy or bilio-digestive anastomosis
  • Contraindication to performing a general anesthesia
  • Contraindication to performing an MRI scan
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  • Allergy to anthracyclines, iodine or gadolinium
  • Contraindication to the injection of gadolinium-based contrast media.
  • Contraindication to iodinated contrast agents
  • Contraindication to Idarubicin (hypersensitivity to the active substance or excipients, severe heart disease, severe arrhythmia, severe renal or hepatic impairment, yellow fever vaccine or any other live attenuated vaccine for 6 months after discontinuation of chemotherapy, persistent myelosupressure, previous treatments with idarubicin and / or other anthracyclines or anthracenediones at maximum cumulative doses, mucositis, breastfeeding, uncontrolled infections, severe heart failure, myocardial infarction less than 6 months old).
  • Contraindication to Lipiodol (Hypersensitivity, Hyperthyroidism, traumatic lesions, haemorrhage or recent bleeding)
  • Patients who have already received or exceeded the recommended cumulative dose for anthracyclines (Idarubicin = 150 mg / m²)
  • Patients who cannot temporarily stop their anticoagulant treatment or anti-platelet agent for the duration of the procedure
  • Failure of endoscopic eradication of oesophageal varices of grade > 1
  • Inability to adhere to the protocol
  • Simultaneous participation to another clinical trial
  • Patients not covered by health insurance

Trial locations and contacts

1 site in 1 country.

France1 site

  • UH Montpellier

    Montpellier

Other trials in France

About this study

Official title: Hepatocellular Carcinoma Under 3 cm Treated by Percutaneous Tumor Destruction: Multicentric Phase 2 Test Evaluating the Impact of Adjuvant Chemotherapy by Intra-arterial Infusion of Idarubicin-lipiodol on the Hepatic Recurrence

The aim of this study is to test whether the realization of 3 courses of intra-arterial chemotherapy of idarubicin-lipiodol without embolization, administered non-selectively in the hepatic artery, following the percutaneous tumour ablation of a hepatocellular carcinoma, could constitute an effective adjuvant treatment to reduce the rates of local and intrahepatic distant recurrence and thus improve the survival without hepatic progression.

Read the detailed description

During this study percutaneous tumor destruction treatment with adjuvant chemotherapy (infusion of Idarubicin-Lipiodol intra-arterial hepatic) will be tested. The adjuvant chemotherapy is a minimally invasive technique. It consists of the administration of Idarubicin (Zavedos®, Pfizer) mixed with Lipiodol (Lipiodol Ultra-Fluid®, Guerbet) in the hepatic artery.The first course of treatment will be performed under general anesthesia at the same time as the percutaneous tumour ablation. The second and third cures will be performed under local anesthesia 3 and 6 weeks after percutaneous tumour ablation respectively. In the case of incomplete treatment during the percutaneous tumour ablation, the second intervention will be scheduled at the same time as the second intra-arterial chemotherapy treatment, under general anesthesia.

Being tested
percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment, Percutaneous destruction of the tumor
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • percutaneous destruction of the tumor + Idarubicin-Lipiodol treatmentDrug

    Patients will receive the standard treatment protocol consisting of a percutaneous destruction of the tumor. In addition they will receive an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin (Zavedos®, Pfizer), which is an anthracycline antineoplastic agent, mixed with Lipiodol (Lipiodol Ultra-Fluid®, Guerbet), which is a contrast agent.

  • Percutaneous destruction of the tumorProcedure or surgery

    Patients will received the standard treatment protocol consisting of a percutaneous destruction of the tumor.

Study groups in NCT04178642
Study groupRoleWhat they receive
(experimental group)ExperimentalEvaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group)
Receives: Drug: percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment
(standard group)Active comparatorThe absence of adjuvant treatment (standard group).
Receives: Procedure: Percutaneous destruction of the tumor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The survival rate without hepatic recurrence at 1 year

    Hepatic recurrence will be defined as the appearance on at least one hepatic MRI with gadolinium injection of a large diameter tumor site at least greater than 10 mm, and presenting characteristics of CHC (hyper vascularization at arterial time and washing at portal or late time), either at the edge of the percutaneous tumor destruction site (= local recurrence) or at a distance from the percutaneous tumor destruction site (= intrahepatic recurrence distant), or both, after at least one liver MRI scan with gadolinium injection showed the absence of tumor residues. Lesions of more than 10 mm that do not present with the typical CHC enhancement described above will be considered CHCs if they have a growth in size of at least 1 cm on successive controls.

    Measured: 1 year

Secondary outcomes (6)

  1. The incidence rate of local tumor recurrence

    The incidence rate of local tumor recurrence at 1 and 2 years, defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma characteristics at the edge of the percutaneous tumor ablation site.

    Measured: 1 to 2 years

  2. The incidence rate of intrahepatic recurrence

    The incidence rate of intrahepatic recurrence at 1 and 2 years defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma characteristics at a distance from the percutaneous tumor ablation site.

    Measured: 1 to 2 years

  3. The incidence rate of hepatic recurrence

    The incidence rate of hepatic recurrence at 2 years defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma, after at least one exploration by hepatic MRI with gadolinium injection, showed the absence of tumor residue.

    Measured: 2 years

  4. Survival without hepatic recurrence

    Survival without hepatic recurrence defined as the time between the date of randomization and the date of liver MRI, having confirmed, after centralized and blind re-examination, the presence of a hepatic tumor recurrence either local or intra distant hepatic. Patients who are deceased or transplanted will be considered to have liver progression at the time of death or transplantation.

    Measured: 2 years

  5. Rate of survival without hepatic recurrence

    Rate of survival without hepatic recurrence at 1 and 2 years defined as the absence of appearance of a large diameter tumor site (at least greater than 10 mm), presenting characteristics of hepatocellular carcinoma on the border of the percutaneous tumour ablation site.

    Measured: 1 to 2 years

  6. Overall survival

    Overall survival defined as the time between the date of randomization and the date of death of the patient.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2019
  2. Study start22 Sep 2020
  3. Primary completion14 Jul 2021
  4. Study completion14 Jul 2021

Why it stopped: no participants enrolled

Resources

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
Model description
Prospective multi-center phase II, randomized, unmasked comparative study (ratio 1:1), evaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group) after percutaneous tumor ablation of hepatocellular carcinoma of size less than 3 cm, versus the absence of adjuvant treatment (standard group), on hepatic recurrence at 1 year. It is planned to include 138 patients with hepatocellular carcinoma (CHC) less than 3 cm, non-metastatic, with cirrhosis graded A / B7 on Child Pugh scoring system, and receiving treatment by percutaneous tumor destruction.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04178642
Sponsor's protocol ID
RECHMPL19_0073
Other IDs
2019-001362-15, 7773, 2019
Acronym
LIDA-ADJ
Status last verified
Aug 2022
First submitted
4 Nov 2019
Last updated
14 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment and Percutaneous destruction of the tumor in people with Hepatocellular Carcinoma, run by University Hospital, Montpellier 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 16 inclusion and 17 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 14 Dec 2022. 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 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 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?

The survival rate without hepatic recurrence at 1 year (time frame: 1 year). 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 NCT04178642.

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 14 Dec 2022.

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LIDA-ADJ Clinical Trial NCT04178642 | AzTrials