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Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma, Liver Cirrhosis

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Trial Information

Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Peri-operative morbidity

Outcome Description:

peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)

Outcome Time Frame:

3 months after surgery

Safety Issue:

Yes

Principal Investigator

Alain Hendlisz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Jules Bordet

Authority:

Belgium: Ethics Committee

Study ID:

TRYPHON

NCT ID:

NCT01686880

Start Date:

September 2012

Completion Date:

October 2018

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cirrhosis
  • Hepatocellular Carcinoma
  • Liver Cirrhosis
  • radioembolization
  • SIRT
  • TARE
  • Sirspheres
  • neoadjuvant
  • liver cancer
  • Carcinoma
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular

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