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The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol (LIDA-ADJ)

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ClinicalTrials.gov Identifier: NCT04178642
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 26, 2019
Last Update Posted Date March 12, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
The survival rate without hepatic recurrence at 1 year [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • The incidence rate of local tumor recurrence [ Time Frame: 1 to 2 years ]
    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.
  • The incidence rate of intrahepatic recurrence [ Time Frame: 1 to 2 years ]
    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.
  • The incidence rate of hepatic recurrence [ Time Frame: 2 years ]
    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.
  • Survival without hepatic recurrence [ Time Frame: 2 years ]
    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.
  • Rate of survival without hepatic recurrence [ Time Frame: 1 to 2 years ]
    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.
  • Overall survival [ Time Frame: 2 years ]
    Overall survival defined as the time between the date of randomization and the date of death of the patient.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol
Official Title  ICMJE 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
Brief 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 treatment to reduce the rates of local and intrahepatic distant recurrence and thus improve the survival without hepatic progression.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment
    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.
  • Procedure: Percutaneous destruction of the tumor
    Patients will received the standard treatment protocol consisting of a percutaneous destruction of the tumor.
Study Arms  ICMJE
  • Experimental: (experimental group)
    Evaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group)
    Intervention: Drug: percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment
  • Active Comparator: (standard group)
    The absence of adjuvant treatment (standard group).
    Intervention: Procedure: Percutaneous destruction of the tumor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2019)
138
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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
  • Contraindication to performing a general anesthesia
  • Contraindication to performing an MRI scan
  • 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).
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christophe CASSINOTTO 0033467339377 c-cassinotto@chu-montpellier.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04178642
Other Study ID Numbers  ICMJE RECHMPL19_0073
2019-001362-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christophe CASSINOTTO University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP