Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Randomised controlled trial, Transarterial chemoembolisation
Brief summary
We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. The aim of this study is to compare the survival of patients undergoing liver resection plus post-operative TACE versus liver resection alone.
Detailed description
Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. This procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients.
Interventions
PROCEDURETransarterial chemoembolisation using cisplatin-lipiodol mixture
Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* HCC patients received curative hepatectomy with negative resection margin * Age from 18 to 70 * Child-Pugh class A * ASA class I to III * ECOG performance status Grade 0 or 1
Exclusion criteria
* Patients receiving concomitant local ablation or previous TACE * Main portal vein tumour thrombus extraction during hepatectomy * Tumour arising from caudate lobe * Presence of extra-hepatic disease * Very early HCC with solitary tumour and size \< 2cm * Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \< 25g/L or bilirubin \> 50micromol/L * Renal impairment with creatinine \> 200micromol/L * Severe concurrent medical illness persisting \> 6 weeks after hepatectomy * History of other cancer * Hepatic artery anomaly making TACE not possible * Allergy to cisplatin or lipiodol * Pregnant woman * Informed consent not available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year recurrence rate | 1-year after hepatectomy | The 1-year recurrence rate after hepatectomy in both arms of study were compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of transarterial chemoembolisation | 3-month after transarterial chemoembolisation | — |
| Health-related quality of life assessment | 1-year after surgery | The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3) |
| Disease-free survival | 5 years after operation | — |
| Overall Survival | 5-year after surgery | — |
Countries
China
Outcome results
None listed