Last Updated on 6 October, 2017
Professor Simon Yu
This randomized phase II study is aimed to evaluate the safety and efficacy of using the new formulation (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the conventional formulation (Lipiodol-cisplatin emulsion).
It is hypothesized that treatment of HCC using a TACE formulation of Lipiodol-cisplatin suspension is more effective than that using Lipiodol-cisplatin emulsion in terms of objective tumor response. The objective is to evaluate the safety and efficacy of TACE using Lipiodol-cisplatin suspension versus Lipiodol-cisplatin emulsion.
This is a prospective, parallel-group, open-label randomized, phase II study that is conducted in accordance to the Declaration of Helsinki and international standards of Good Clinical Practice, and approved by the institutional review board. Eligible patients were randomized into either a treatment arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a 1:1 ratio.
Assessment of eligibility is based on clinical, laboratory, and imaging data that are obtained within 30 days prior to randomization:
- Written informed consent
- Age above 18 years
- HCC unsuitable for resection or ablation
- Child-Pugh A or B cirrhosis
- Eastern Cooperative Oncology Group performance score 0 or 1
- BCLC A or B
- No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
- HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
- No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
- No invasion of portal vein or hepatic vein
- Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)
- Total tumor mass < 50% liver volume
- Size of any individual tumor 12cm in largest dimension
- Known active malignancy within the last 3 years
- Concurrent ischemic heart disease or heart failure
- History of acute tumor rupture presenting with hemo-peritoneum
- Biliary obstruction not amenable to percutaneous or endoscopic drainage
- Child-Pugh C cirrhosis
- History of hepatic encephalopathy
- Intractable ascites not controllable by medical therapy
- History of variceal bleeding within last 3 months
- Serum total bilirubin level > 40 umol/L
- Serum albumin level < 30g/L
- INR > 1.3
- Creatinine clearance < 55 ml/min.
- Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
- Arterio-portal venous shunt affecting >1 hepatic segment on CT
- Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT