Hepatocellular Carcinoma
Conditions
Keywords
HCC, Randomised controlled trial, TACE, Resection
Brief summary
Investigators 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 of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor 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, especially for the patients with high risk factors for residual tumor, such as tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion. 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. The main complications of TACE are liver function damage, mild feverish symptoms, vomit , etc. But most of them are reversible. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients with high risk factors for residual tumor (tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion).
Interventions
DRUGEthiodized Oil + Doxorubicin
TACE using doxorubicin-lipiodol mixture
Sponsors
Jia Fan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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 * Tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion were defined as high risk factors for residual tumor and used for patient stratification. * 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 * 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 doxorubicin or lipiodol * Pregnant woman * Informed consent not available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | 3 years after operation |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 3-year after surgery |
| Complications of transarterial chemoembolisation | 3-month after transarterial chemoembolisation |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed