Hepatectomy Versus Chemoembolization for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

NCT ID: NCT02138981

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 436 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2020-08-31

Brief Summary

The purpose of this study is to compare the survival outcomes between hepatic resection and transarterial lipiodol chemoembolization (TACE) used as the initial treatment in patients with Resectable Hepatocellular Carcinoma Beyond Milan Criteria.

Detailed Description

For patients with large/multiple, and resectable hepatocellular carcinomas (HCCs) without macrovascular invasion or extrahepatic spread, the choice of treatment remains largely controversial. For these patients, transarterial lipiodol chemoembolization (TACE) is recommended as a palliative therapy.

On the other hand, many authors still believe that hepatic resection is the only potential curative treatment in these patients because it is still feasible to remove all macroscopic tumors safely at surgery. With advances in surgical techniques, more large/multiple HCCs are now resectable, and long-term results have been reported that ranged from 30% to 58% at 5 years; even patients with large bilobar multiple HCC could reach a survival rate of more than 20% at 5 years after hepatic resection.

Until now, there have been only a few studies that compared the outcomes of hepatic resection and TACE in the treatment of multiple HCCs, and these have reported controversial results. Some studies showed that hepatic resection had survival benefi t over TACE, but other studies showed the opposite result ( 11-15 ). Therefore, the investigators performed this prospective study in consecutive patients with large/multiple, and resectable HCCs to compare the outcomes in patients who underwent hepatic resection or TACE as the initial treatment.

Conditions

Resectable Hepatocellular Carcinoma Beyond Milan Criteria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate Resection

patients received immediate surgical hepatic resection

Group Type: ACTIVE_COMPARATOR

Immediate Resection

Intervention Type: PROCEDURE

patients received immediate surgical resection.

Chemoembolization and Response-Dependent Resection

patients underwent transarterial chemoembolization (TACE) as initial treatments, and only patients who showed good response were subjected to surgical resection.

Group Type: EXPERIMENTAL

Chemoembolization and Response-Dependent Resection

Intervention Type: PROCEDURE

patients underwent transarterial chemoembolization (TACE) as initial treatments, and only patients who showed good response were subjected to surgical resection.

Interventions

Chemoembolization and Response-Dependent Resection

patients underwent transarterial chemoembolization (TACE) as initial treatments, and only patients who showed good response were subjected to surgical resection.

Intervention Type: PROCEDURE

Immediate Resection

patients received immediate surgical resection.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• A diagnosis of HCC based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
• The patient has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
• The tumor beyound milan criteria.
• The tumor was evaluated to be resectable by a same group of surgeon.
• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria
• No serious concurrent medical illness
• Not pregnant or breast-feeding patients
• Cirrhotic status of Child-Pugh class A only
• The following laboratory parameters:

• Platelet count ≥ 80,000/µL
• Hemoglobin ≥ 8.5 g/dL
• Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L
• ASL and AST ≤ 5 x upper limit of normal
• Serum creatinine ≤ 1.5 x upper limit of normal
• INR ≤ 1.5 or PT/APTT within normal limits
• Absolute neutrophil count (ANC) >1,500/mm3
• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria

• Tumor vascular invasion or distant metastases
• Significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
• On anticoagulation or suffering from a known bleeding disorder
• Unstable coronary artery disease or recent MI
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
• Serious non-healing wound, ulcer, or bone fracture
• Known central nervous system tumors including metastatic brain disease
• severe Arterioportal Shunts or Arteriavein Shunts

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Kaiping Central Hospital

OTHER

Sponsor Role: collaborator

First People's Hospital of Chenzhou

OTHER

Sponsor Role: collaborator

Dongguan Shi People's Hospital

UNKNOWN

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Shi Ming

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Shi, MD

Role: CONTACT

shiming@mail.sysu.edu.cn

86-2087343154

Rong Ping Guo, MD

Role: CONTACT

guorongp@mail.sysu.edu.cn

86-2087342266

Facility Contacts

Ming Shi, MD

Role: primary

shiming@mail.sysu.edu.cn

86-2087343115

Other Identifiers

HCC_S012

Identifier Type: -

Identifier Source: org_study_id