The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatocellular Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 Li...
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.
Tracking Information
- NCT #
- NCT04178642
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Christophe CASSINOTTO University Hospital, Montpellier
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