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

NCT ID: NCT04178642

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2021-07-14

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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(experimental group)

Evaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group)

Group Type EXPERIMENTAL

percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment

Intervention Type DRUG

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.

(standard group)

The absence of adjuvant treatment (standard group).

Group Type ACTIVE_COMPARATOR

Percutaneous destruction of the tumor

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DRUG

Percutaneous destruction of the tumor

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
* Patients who previsouly received sphincterotomy or bilio-digestive anastomosis
* 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)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe CASSINOTTO

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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UH Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2019-001362-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7773

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL19_0073

Identifier Type: -

Identifier Source: org_study_id