Status:
COMPLETED
Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The most frequently used products in CHE are doxorubicin (36%), cisplatin (31%), and epirubicin (12%). But until recently, there were no obvious reasons to use one product over another. In fact, syste...
Detailed Description
By using a 2-step Fleming plan (Fleming, 1982) with a unilateral alpha risk of 5% and 90% potency, it is necessary to include 86 assessable patients. On the 1st step: 43 patients will be included (+/...
Eligibility Criteria
Inclusion
- \- Histologically diagnosed HCC or HCC diagnosed according to the EASL criteria
- Measurable targets according to the mRECIST v1.1 criterion
- Preserved liver function (in case of Child-Pugh A or B7 cirrhosis)
- Tumour not subject to interventive care (liver transplant, surgical resection or percutaneous destruction)
- BCLC A/B without portal or extra-hepatic invasion
- No prior treatment by chemotherapy, radiotherapy or transarterial embolisation (with or without chemotherapy)
- Age ≥ 18 years
- WHO 0 or 1
- Laboratory test: platelets ≥ 50,000 mm3, N ≥ 1,000/mm3, creatininaemia ≤ 150 µmol/L, PT ≥ 50%
- No heart failure (isotope or ultrasound VEF \> 50%)
Exclusion
- \- Advanced tumour (vascular or extra-hepatic invasion including brain metastasis or diffuse HCC with liver invasion \> 50%)
- History of other type of cancer except cancer known to be in remission for more than 5 years (in this case, HCC histological proof is required), or basal-cell carcinoma or in situ cervix uteri cancer properly treated with curative treatment
- Advanced liver disease (Child B8, B9 and C, bilirubinaemia \> 3 mg/dL, SGOT and SGPT \> 5 x ULN or 250 U/L)
- Previous treatment by idarubicin and/or doxorubicin
- Idarubicin contraindications (cardiopathy with myocardial failure, serious kidney or liver failure, yellow fever vaccine)
- Concurrent disease or uncontrolled severe clinical condition
- Uncontrolled severe infection
- Patient requiring long-term anticoagulant treatment
- Thrombosis of the portal vein or a 3-segment region or more
- Hepatofugal portal venous flow
- Presence of serious atheromatosis
- Presence of collateral vascular ways potentially affecting the normal regions during embolisation
- Presence of arthritis of the hepatic artery branches to be treated
- Presence of arterioportal or arterial subhepatic fistula that cannot be embolised by coils
- Pregnancy or breastfeeding
- Absence of effective contraception (for men and women of childbearing age)
- Patient who cannot be regularly monitored on account of psychological, social, family- or geography-related reasons
- Concomitant participation of a patient in another study
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02185768
Start Date
January 1 2015
End Date
October 1 2017
Last Update
July 4 2025
Active Locations (7)
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1
CHU Amiens
Amiens, France
2
CHU d'ANGERS
Angers, France, 49933
3
CHU - Hôpital François Mitterand
Dijon, France, 21079
4
Hôpital La Croix Rousse
Lyon, France, 69317