Clinical trial NCT01686880: Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
Official title: Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Liver Cirrhosis
Keywords: Hepatocellular Carcinoma
Liver Cirrhosis
radioembolization
SIRT
TARE
Sirspheres
neoadjuvant
liver cancer
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma

Detailed description: The purpose of this study is to assess the peri-operative morbidity and mortality of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
* HCC with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
* Borderline resectable disease eligible for surgical resection or radiofrequency destruction.
* No extra-hepatic dissemination.
* ECOG Performance status \< 2.
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Signed written informed consent (approved by an Independent Ethics Committee) obtained prior to any study specific baseline procedures.

Exclusion Criteria:

* Decompensated cirrhosis (Child Pugh B, C).
* Extra-hepatic tumour spread.
* Previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
* Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
* Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, ...).
* Previous trans-arterial radioembolization (TARE).
* History of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials.
* Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
* Major surgery within four weeks.
* Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Uncontrolled Diabetes.

Primary outcomes:
measure: Peri-operative morbidity
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Survival
timeFrame: 3 years
measure: One and three years survival
timeFrame: one and three years
measure: Tumor regression
timeFrame: 8 weeks after Trans-arterial radioembolization
measure: Functional Imaging
timeFrame: 3 years
measure: Contra-lateral Lobe Hypertrophy
timeFrame: 3 Years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Erasme Hosptial
Study officials:
affiliation: Jules Bordet Institute
name: Alain Hendlisz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasme University Hospital
name: Vincent Donckier, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemaire M, Lucidi V, Bouazza F, Katsanos G, Vanderlinden B, Levillain H, Delatte P, Garcia CA, Vouche M, Galdon MG, Demetter P, Deleporte A, Hendlisz A, Flamen P, Donckier V. Selective internal radiation therapy (SIRT) before partial hepatectomy or radiofrequency destruction for treatment of hepatocellular carcinoma in cirrhotic patients: a feasibility and safety pilot study. HPB (Oxford). 2018 Jul;20(7):641-648. doi: 10.1016/j.hpb.2018.01.006. Epub 2018 Feb 24.