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Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma

Phase 3
18 Years
70 Years
Open (Enrolling)
Hepatocellular Carcinoma

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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:


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:


Principal Investigator

Yue Sun Cheung, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong


Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Randomised controlled trial
  • Transarterial chemoembolisation
  • Carcinoma
  • Carcinoma, Hepatocellular