Clinical trial NCT01966133: TACE as an Adjuvant Therapy After Hepatectomy for HCC
Official title: Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Randomised controlled trial
TACE
Resection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 280
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: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 years after operation
Secondary outcomes:
measure: Overall Survival
timeFrame: 3-year after surgery
measure: Complications of transarterial chemoembolisation
timeFrame: 3-month after transarterial chemoembolisation
Other outcomes:
measure: Health-related quality of life assessment
timeFrame: 1-year after surgery
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Liver cancer institute, Fudan university
name: Jia Fan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liver Cancer Institute, Zhong Shan Hospital, Fudan University
name: Jian Zhou, MD
role: STUDY_DIRECTOR
References: