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

Phase 3

Active, not recruiting

• Conditions: Patients with locally advanced HCC or recurrent HCC; Cancer - Liver

• Registration Number: ACTRN12617000030370
• Lead Sponsor: ational Cancer Centre Singapore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-09
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 819

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
ALPlesser 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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];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];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];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 ]