Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
18 Years
70 Years
Both
Hepatocellular Carcinoma
Trial Information
Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1-year recurrence rate
Outcome Description:
The 1-year recurrence rate after hepatectomy in both arms of study were compared
Outcome Time Frame:
1-year after hepatectomy
Safety Issue:
No
Principal Investigator
Yue Sun Cheung, MBChB
Investigator Role:
Principal Investigator
Investigator Affiliation:
Chinese University of Hong Kong
Authority:
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study ID:
CRE-2011.236-T
NCT ID:
NCT01512407
Start Date:
January 2012
Completion Date:
Related Keywords:
- Hepatocellular Carcinoma
- Hepatocellular Carcinoma
- Randomised controlled trial
- Transarterial chemoembolisation
- Carcinoma
- Carcinoma, Hepatocellular
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