Brief Summary

The role of transarterial chemoembolization (TACE) as the standard therapy for intermediate-stage hepatocellular carcinoma (HCC) is being challenged by increasing studies which showed that liver resection (LR) is a safe and feasible procedure with better survival outcomes than TACE does. In light of this, the investigators have constructed a Markov model to simulate comparing LR and TACE in the treatment of intermediate-stage HCC. The results suggested that LR may provide survival benefit over TACE for the treatment of intermediate-stage HCC in cirrhotic patients. However, validating the simulated result by a study with higher quality (e.g. prospective clinical trial) would be of great value in providing a more convincing finding. Therefore, based on the established Markov model, the investigators aimed to prospectively compare the treatment efficacy and safety of LR with TACE for consecutive patients with intermediate-stage HCC.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

198

participants targeted

Target at P25-P50 for phase_3 hepatocellular-carcinoma

Timeline

Completed

Started Mar 2014

Shorter than P25 for phase_3 hepatocellular-carcinoma

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

March 1, 2014

Completed

2.1 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2016

Completed

25 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed

Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

April 3, 2016

Last Update Submit

April 27, 2016

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

Overall survival
1-year overall survival
1 year

Secondary Outcomes (1)

Mortality
1 month

Study Arms (2)

liver resection

EXPERIMENTAL

Resection was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant and the possibility of a negative resection margin. The investigators performed anatomical resection aiming at a resection margin of at least 1 cm. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 minutes and 5 minutes, respectively. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.

Procedure: liver resection

transarterial chemoembolization

ACTIVE COMPARATOR

A microcatheter was inserted into the feeding arteries as selectively as possible through the lobar, segmental, or subsegmental arteries, dependent on the tumor distribution and hepatic functional reserve. Hepatic artery infusion chemotherapy was performed using 300 mg carboplatin. Subsequently, chemolipiodolization was performed mixed with 5 ml of lipiodol. According to the number and size of the lesions, and liver and kidney function of the patient, the chemotherapeutic agents, including epirubicin (50-100 mg), pirarubicin (30-50 mg), hydroxycamptothecin (10-30 mg) and fluorouracil (500-1000 mg), were determined by the multidisciplinary team. If residual flow remained after infusion of these agents, additional lipiodol was injected. Embolization was performed with absorbable gelatin sponge particles 350-560 μm in diameter.

Procedure: transarterial chemoembolizationDrug: carboplatinDrug: lipiodolDrug: epirubicin , pirarubicin , hydroxycamptothecin and fluorouracilOther: absorbable gelatin sponge particles

Interventions

liver resectionPROCEDURE

Intraoperative ultrasound was routinely used during surgery. Anatomic resection was carried out in the form of segmentectomy or/and subsegmentectomy.In segmentectomy, the hepatic parenchyma was transacted at the intersegmental plane as described by Couinaud. If the hepatic parenchymal transaction plane needed to go beyond the intersegmental plane to achieve the desired extent of resection margin, the small portal branches supplying the liver parenchyma up to the intended transaction plane were punctured under US guidance and injected with methylthioninium chloride, and then liver subsegmentectomy was performed either alone or in combination with segmentectomy along the plane of demarcation as delineated by the injected methylthioninium chloride. Nonanatomic resection with a negative resection margin was performed when anatomical resection may cause inadequate liver remnant. Pringle's maneuver was used if necessary with a clamp/unclamp time of 10 min/5 min.

Also known as: Hepatectomy

liver resection

transarterial chemoembolizationPROCEDURE

Also known as: chemoembolization through artery, TACE