Clinical trial NCT01512407: RCT on Adjuvant TACE After Hepatectomy for HCC
Official title: Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Randomised controlled trial
Transarterial chemoembolisation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-year recurrence rate
timeFrame: 1-year after hepatectomy
Secondary outcomes:
measure: Disease-free survival
timeFrame: 5 years after operation
measure: Overall Survival
timeFrame: 5-year after surgery
measure: Complications of transarterial chemoembolisation
timeFrame: 3-month after transarterial chemoembolisation
measure: Health-related quality of life assessment
timeFrame: 1-year after surgery
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Yue Sun Cheung, MBChB
role: PRINCIPAL_INVESTIGATOR
References: