Prospective Meta-analysis of Selective Internal Radiation Therapy (SIRT) versus Sorafenib for Hepatocellular Carcinoma

• Register: ANZCTR
• Last refreshed on: 7 January 2019
• Main ID: ACTRN12617000030370
• Date of registration: 09/01/2017
• Prospective Registration: No
• Primary sponsor: National Cancer Centre Singapore
• Public title: Prospective Meta-analysis of Selective Internal Radiation Therapy (SIRT) versus Sorafenib for Hepatocellular Carcinoma
• Scientific title: Individual Patient Data Prospective Meta-analysis (IPD PMA) of Selective Internal Radiation Therapy (SIRT) versus Sorafenib for Locally Advanced or Recurrent Hepatocellular Carcinoma (HCC) Including SARAH and SIRveNIB Trials
• Date of first enrolment: 16/07/2010
• Target sample size: 827
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12617000030370.aspx
• Study type: Observational
• Study design: Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Phase 3

Countries of recruitment

Brunei Darussalam, France, Hong Kong, Indonesia, Korea, Republic Of, Malaysia, Mongolia, Myanmar, New Zealand, Philippines, Taiwan, Province Of China, Thailand

Contacts

• Name: Prof Pierce Chow

• Name: Prof Pierce Chow

Key inclusion & exclusion criteria

Inclusion criteria: *Adults (older than or equal to 18 years of age) with a life expectancy of over 3 months.
*Histologic or cytologic diagnosis or AASLD criteria for the diagnosis of HCC and at least one measurable lesion on CT according to RECIST criteria
*Written consent.
*Patients with advanced HCC according to the Barcelona criteria (stage C), with or without portal invasion, and who are not eligible for surgical resection, liver transplantation or radiofrequency (ablation) OR patients with recurrent HCC (new
location) or patients with chemoembolisation failure.
*ECOG performance status lesser or equal to 1.
*Liver cirrhosis Child-Pugh A - B7.

SIRveNIB only:
Adequate haematological, renal and hepatic function as follows*:
Leukocytes greater or equal to 2,500/µL
Platelets greater or equal to 80,000/µL
Haemoglobin greater than 9.5 g/dL
Total bilirubin lesser than 2.0 mg/dL
INR lesser or equal to 2.0
ALP lesser or equal to 5 x institutional upper limit of normal
AST and ALT lesser or equal to 5 x institutional upper limit of normal
Albumin greater or equal to 2.5 g/dL
Creatinine lesser or equal to 2.0 mg/dL

*Suitable for protocol treatment as determined by clinical assessment undertaken by the Investigator.
SARAH only:
*Neutrophils greater or equal to 1500/mm3.
*Platelets greater or equal to 50000/mm3.
*Haemoglobin greater or equal to 9 g/100 mL.
*Bilirubin lesser or equal to 50 µmol/L.
*INR lesser or equal to 1.5.
*AST or ALT lesser or equal to 5 x ULN.
*Adequate kidney function, creatinine lesser 150 µmol.

*Patient affiliated to social security scheme or beneficiary.

Exclusion criteria: *Advanced Liver disease with A Child-Pugh score > B7 or active digestive haemorrhage or encephalopathy or refractory ascites.
*Patient unable or unwilling to comply with the treatment and follow-up required by the trial.
*Previously treated advanced HCC (excluding chemoembolisation).
*Contraindication to hepatic artery catheterisation such as severe peripheral arterial disease precluding catheterisation.
*Allergy to contrast agents.
*Pregnant or breastfeeding women.
*Mental illness or Other psychological disorder affecting the informed consent.
SARAH only:
*Patient unable to take oral medication.
*Extrahepatic metastases (including pulmonary tumours > 1 cm and lymph node tumours > 2 cm).
*Other primary tumour except for basal-cell carcinomas or superficial bladder cancers.
SIRveNIB only:
*Complete obstruction of the main portal vein.
*Extrahepatic metastases except patients with small lung nodules or lymph nodes.
*Portal hypertension with hepatofugal flow as documented on baseline spiral CT scan.
*Male patients must be surgically sterile, or if sexually active and having a pre-menopausal female partner then must be using an acceptable form of contraception.


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Patients with locally advanced HCC or recurrent HCC;
Patients with locally advanced HCC or recurrent HCC

Cancer - Liver

Intervention(s)

Selective Internal Radiation Therapy (SIRT) using SIR-Spheres yttrium-90 microspheres.
1. This is a retrospective meta-analysis using individual patient data from 2 trials that have completed recruitment.
2.
SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma (SARAH) - NCT01482442 - December 2011 - April 2016
Study to Compare Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (HCC) (SIRveNIB) - NCT01135056 - July 2010 - September 2016

Primary Outcome(s)

Overall survival - this outcome is assessed by review of SARAH and SIRveNIB trial data. [Time from randomisation until death from any cause or the end of the trial]

Secondary Outcome(s)

Progression free survival - this outcome is assessed by review of SARAH and SIRveNIB trial data. [Time from randomization until disease progression or death at the end of the trial]

Tumour response rate - this outcome is assessed by review of SARAH and SIRveNIB trial data. [3 months from randomization until progression or the end of the trial]

Toxicities level this outcome is assessed by review of SARAH and SIRveNIB trial data. [Time from the start of treatment until 30 days from the last dose of Sorafenib or 6 months from the last dose of SIRT ]

Progression in the liver - this outcome is assessed by review of SARAH and SIRveNIB trial data. [Time from randomization until the first progression in the liver or the end of the trial]

Disease control rate - this outcome is assessed by review of SARAH and SIRveNIB trial data. [3 months from randomization until progression or the end of the trial]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

Sirtex Medical Limited

National Medical Research Council

Secondary Sponsor(s)

Assistance Publique - Hopitaux de Paris

Ethics review

Status: Not required
Approval date:
Contact:

Epworth HealthCare Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 11/12/2018