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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617000030370

Acronym

VESPRO

Enrollment

819

Registered

2017-01-09

Start date

2010-07-16

Completion date

2016-05-25

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is an individual patient prospective meta-analysis, from two randomised open label phase III efficacy trials examining survival benefits as their primary outcome, SARAH and SIRveNIB, both which have completed recruitment and are currently in follow-up . To date, no results regarding the survival by randomised group have reported. The aim of this meta-analysis is to improve the strength of the evidence on the benefit or potential non-inferiority of selective internal radiation therapy (SIRT), also known as radioembolisation, compared to Sorafenib with respect to overall survival.

Interventions

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 -

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results