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Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion : Phase II, single arm, Multicentric

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515456-20-00
Acronym
LIDA-BII
Enrollment
53
Registered
2024-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-21

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

Conditions

Hepato carcinoma cancer

Brief summary

Disease control rate (partial, complete or stable response) at 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.

Detailed description

Time until treatment failure defined as the time interval between the inclusion date and the date of treatment failure. Patients alive without treatment failure will be censored on the latest news date. Treatment failure is defined as progression, the appearance of toxicities, or the inability to administer chemotherapy., Progression-free survival: defined as the time interval between the date of inclusion and the date of first progression or death (whatever the cause). Patients living without progress will be censored on the date of the last news., The rate of patients in objective response (complete response or partial response) at 6 months to from the date of the first course of chemo-lipiodol according to the mRECIST criteria evaluated according to the investigator and centralized proofreading, Tolérance defined by the NCI CTC AE v4.03 scale., Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol at baseline, and 2, 4, 6, 12 months after the first cycle, The rate of thrombosis/hepatic arterial stenosis defined as the number of courses lasting which vascular thrombosis or stenosis is/are visible on arteriography initial hepatic artery(s), divided by the total number of cures., Overall survival defined as the time interval between the date of inclusion and the date of death (all causes). Patients alive without progression will be censored on the date of latest news.

Interventions

DRUGsolution injectable
DRUGZAVEDOS 10 mg

Sponsors

Centre Hospitalier Universitaire De Montpellier
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease control rate (partial, complete or stable response) at 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.

Secondary

MeasureTime frame
Time until treatment failure defined as the time interval between the inclusion date and the date of treatment failure. Patients alive without treatment failure will be censored on the latest news date. Treatment failure is defined as progression, the appearance of toxicities, or the inability to administer chemotherapy., Progression-free survival: defined as the time interval between the date of inclusion and the date of first progression or death (whatever the cause). Patients living without progress will be censored on the date of the last news., The rate of patients in objective response (complete response or partial response) at 6 months to from the date of the first course of chemo-lipiodol according to the mRECIST criteria evaluated according to the investigator and centralized proofreading, Tolérance defined by the NCI CTC AE v4.03 scale., Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol at baseline, and 2, 4, 6, 12 months after the first cycle

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026