Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver

NCT01686880 | Terminated Phase 2

• 1 other identifier: TRYPHON
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Conditions

Hepatocellular Carcinoma; Liver Cirrhosis

Keywords

Hepatocellular Carcinoma; Liver Cirrhosis; radioembolization; SIRT; TARE; Sirspheres; neoadjuvant; liver cancer

Outcome Measures

Primary Outcomes (1)

• Peri-operative morbidity

  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)

  3 months after surgery

Secondary Outcomes (5)

• Survival

  3 years

• One and three years survival

  one and three years

• Tumor regression

  8 weeks after Trans-arterial radioembolization

• Functional Imaging

  3 years

• Contra-lateral Lobe Hypertrophy

  3 Years

Study Arms (1)

Preoperative aTARE

EXPERIMENTAL

The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery

Device: Sirsphere trans-arterial radioembolization

Interventions

Sirsphere trans-arterial radioembolization DEVICE

Patients will receive Sirsphere trans-arterial radioembolization before surgery

Also known as: TARE, SIRT

Preoperative aTARE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (2)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Erasme Hosptial

Brussels, 1070, Belgium

Location

Related Publications (1)

• 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.

  PMID: 29486918 DERIVED

Related Links

• Jules Bordet Institute
• Erasme Hospital

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alain Hendlisz, MD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

• Vincent Donckier, MD, PHD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 18, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

BE (2)