Evaluation of the efficacy and tolerance of a chemotherapy by Idarubicin and Lipiodol emulsion administer in the liver, by the hepatic artery, on hepatocellular carcinoma.

Treatment of hepatocellular carcinoma on child cirrhosis A/B7 by intra-arterial injection of a Lipiodol and Idarubicin emulsion : a multicentric single-arm phase II study - LIDA-BII

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004859-22-FR

Enrollment

Registered

2018-04-27

Start date

2018-04-12

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The research hypothesis is that hepatic locoregional treatment without embolization, using a more cytotoxic anticancer molecule (Idarubicin) than those conventionally used, would be more effective. MedDRA version: 20.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864

Interventions

Trade Name: Zavedos (Idarubicin) Pharmaceutical Form: Solution for injection Trade Name: LIPIODOL Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histologically proven hepatocellular carcinoma (or according to EASL criteria) • Child-Pugh A or B7 cirrhosis • Tumor not accessible to surgical resection, percutaneous ablation or radiofrequency • WHO 0 or 1 • BCLC A / B or C if WHO = 1 • Targets measurable according to mRECIST criteria v1.1 • No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation • Age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Advanced tumor disease • Diffuse hepatocellular carcinoma with liver invasion> 50% • Past cancers history excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ adequately treated with curative intent • Advanced liver disease (Child B8, B9 and C) • Contraindication to performing a liver MRI • Contraindication to the injection of gadolinium-based contrast media • Contraindication to Idarubicin • Contraindication to Lipiodol • Vascular anatomy makes it impossible to perform intra-arterial liver treatments • Ligation or sizing of gastroesophageal varices for less than a month. • Pregnancy (determination of positive ßHCG) or breastfeeding according to article L1121-5 of the CSP.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to evaluate the disease control rate (complete response, partial or stabilization) 4 months from the date of the first cycle of chemotherapy-lipiodol according to the criteria mRECIST.;Secondary Objective: The secondary objectives are to evaluate: ? The time until treatment fails, ? Progression-free survival ? The objective response rate at 6 months from the date of the first chemotherapy-lipiodol cycle, ? The tolerance of the treatment, ? Overall survival at 12 months from the date of the first cycle of chemotherapy-lipiodol, ? The quality of life at 12 months from the date of the first chemotherapy treatment-lipiodol, ? The rate of thrombosis / hepatic arterial stenosis after each course of chemo-Lipiodol.;Primary end point(s): The primary endpoint is the percentage of patients with disease control (complete, partial or stabilized response) 4 months from the date of the first chemo-lipiodol cycle according to mRECIST criteria.;Timepoint(s) of evaluation of this end point: 4 months after the first cycle of chemo-lipiodol	—

Measure

Time frame

Main Objective: The main objective is to evaluate the disease control rate (complete response, partial or stabilization) 4 months from the date of the first cycle of chemotherapy-lipiodol according to the criteria mRECIST.;Secondary Objective: The secondary objectives are to evaluate: ? The time until treatment fails, ? Progression-free survival ? The objective response rate at 6 months from the date of the first chemotherapy-lipiodol cycle, ? The tolerance of the treatment, ? Overall survival at 12 months from the date of the first cycle of chemotherapy-lipiodol, ? The quality of life at 12 months from the date of the first chemotherapy treatment-lipiodol, ? The rate of thrombosis / hepatic arterial stenosis after each course of chemo-Lipiodol.;Primary end point(s): The primary endpoint is the percentage of patients with disease control (complete, partial or stabilized response) 4 months from the date of the first chemo-lipiodol cycle according to mRECIST criteria.;Timepoint(s) of evaluation of this end point: 4 months after the first cycle of chemo-lipiodol

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints will be: ? Time to treatment failure defined between the inclusion date and the date of treatment failure or the date of the latest news. ? Progression-free survival defined as the time between the date of inclusion and the date of first radiological progression or death (whichever comes first) or the date of last new. ? The objective response rate (complete response or partial response) at 6 months from the date of the first chemo-lipiodol treatment according to the mRECIST criteria evaluated according to the investigator and centralized re-reading. ? The tolerance defined according to the NCI-CTC AE scale (version 4.03 published on June 14, 2010) ? Overall survival defined as the time between the date of inclusion and the date of death or the date of last news. ? The quality of life evaluated using the QLQ-C30 specific questionnaire of the European Organization for Research and Treatment of Cancer (EORTC). ? The rate of thrombosis / hepatic arterial stenosis defined as the number of cycle during which vascular thrombosis or stenosis are visible on the initial arteriogram of the hepatic artery, divided by the total number of cures.;Timepoint(s) of evaluation of this end point: 4 months after the first cycle of chemo-lipiodol	—

Measure

Time frame

Secondary end point(s): Secondary endpoints will be: ? Time to treatment failure defined between the inclusion date and the date of treatment failure or the date of the latest news. ? Progression-free survival defined as the time between the date of inclusion and the date of first radiological progression or death (whichever comes first) or the date of last new. ? The objective response rate (complete response or partial response) at 6 months from the date of the first chemo-lipiodol treatment according to the mRECIST criteria evaluated according to the investigator and centralized re-reading. ? The tolerance defined according to the NCI-CTC AE scale (version 4.03 published on June 14, 2010) ? Overall survival defined as the time between the date of inclusion and the date of death or the date of last news. ? The quality of life evaluated using the QLQ-C30 specific questionnaire of the European Organization for Research and Treatment of Cancer (EORTC). ? The rate of thrombosis / hepatic arterial stenosis defined as the number of cycle during which vascular thrombosis or stenosis are visible on the initial arteriogram of the hepatic artery, divided by the total number of cures.;Timepoint(s) of evaluation of this end point: 4 months after the first cycle of chemo-lipiodol

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Countries

France

Contacts

Public ContactCadène Anne

University Hospital of Montpellier

a-cadene@chu-montpellier.fr003346330814

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026