Meta-Analysis SARAH / SIRVENIB

All, I think this is new and it relates to the meta-analysis that is to be carried out in conjunction with the release of the SARAH / SIRveNIB trials.  

Would be grateful if anyone could read the tea-leaves and pick out something interesting:
http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12617000030370

The only thing which strikes me is this phrase: "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)".  I was of the opinion that they were going to publish more information on the meta-analysis that would be conducted - eg the patient cohorts that would be pre-defined.

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Trial ID

ACTRN12617000030370
Date registered

09 January 2017
Health condition

Patients with locally advanced HCC or recurrent HCC
Recruitment countries

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

Recruitment status

Active, not recruiting
Anticipated date of first participant enrolment

n/a
Ethics application status

Not required
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.

Key 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.
Minimum age

18 Years
Maximum age

No limit
Gender

Both males and females
Key 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.