The primary objective of this study is to assess the efficacy of SIRT as compared with Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS).
The Study null hypothesis is, there is no difference in overall survival between patients receiving SIRT and those receiving Sorafenib therapy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Disease must be locally advanced as defined by BCLC (B) intermediate stage or BCLC (C) advanced stage without extra-hepatic disease (only with branch portal vein thrombosis).
* Willing, able and mentally competent to provide written informed consent prior to any testing undertaken for this study protocol, including screening tests and evaluations that are not considered to be part of the subject's routine care.
* Aged 18 years/older (either gender).
* Unequivocal diagnosis of HCC.
* HCC not amenable to surgical resection or immediate liver transplantation, or cannot be optimally treated with local ablative techniques such as RFA, consistent with the practice of the clinical trial centre.
* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with spiral CT scan or MRI.
* ECOG performance status 0-1.
* Child-Pugh A-B (up to 7 points)
* Adequate haematological, renal and hepatic function as follows:
* Leukocytes ≥ 2,500/μL
* Platelets ≥ 80,000/μL
* Haemoglobin \> 9.5g/dL
* Total bilirubin \< 2.0mg/dL
* INR ≤ 2.0
* ALP ≤ 5 x institutional ULN
* AST and ALT ≤ 5 x institutional ULN
* Albumin ≥ 2.5g/dL
* Creatinine ≤ 2.0mg/dL
* Life expectancy of at least 3 months without any active treatment.
* Suitable for protocol treatment as determined by clinical assessment undertaken by the Investigator.
* Female patients must be either postmenopausal or, if premenopaus…