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Hepatectomy Versus Chemoembolization for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

Primary Purpose

Resectable Hepatocellular Carcinoma Beyond Milan Criteria

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Chemoembolization and Response-Dependent Resection

Immediate Resection

About this trial

This is an interventional treatment trial for Resectable Hepatocellular Carcinoma Beyond Milan Criteria focused on measuring Hepatocellular Carcinoma, Milan Criteria

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cancer Center Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Immediate Resection

Chemoembolization and Response-Dependent Resection

Arm Description

patients received immediate surgical hepatic resection

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

Outcomes

Primary Outcome Measures

overall survival time

Secondary Outcome Measures

disease free survival

Number of Adverse Events

All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.

Full Information

NCT ID

NCT02138981

First Posted

May 13, 2014

Last Updated

July 31, 2018

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Kaiping Central Hospital, First People's Hospital of Chenzhou, Dongguan Shi People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02138981

Brief Title

Hepatectomy Versus Chemoembolization for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

Official Title

Hepatic Resection Versus Transarterial Chemoembolization as the Initial Treatment for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2014 (undefined)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Kaiping Central Hospital, First People's Hospital of Chenzhou, Dongguan Shi People's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable Hepatocellular Carcinoma Beyond Milan Criteria

Keywords

Hepatocellular Carcinoma, Milan Criteria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

436 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immediate Resection

Arm Type

Active Comparator

Arm Description

patients received immediate surgical hepatic resection

Arm Title

Chemoembolization and Response-Dependent Resection

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Chemoembolization and Response-Dependent Resection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Immediate Resection

Intervention Description

patients received immediate surgical resection.

Primary Outcome Measure Information:

Title

overall survival time

Time Frame

5 years

Secondary Outcome Measure Information:

Title

disease free survival

Time Frame

5 years

Title

Number of Adverse Events

Description

All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Shi, MD

Phone

86-2087343154

shiming@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Rong Ping Guo, MD

Phone

86-2087342266

guorongp@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Shi, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Center Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Shi, MD

Phone

86-2087343115

shiming@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Ming Shi, MD

12. IPD Sharing Statement

Learn more about this trial

Hepatectomy Versus Chemoembolization for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

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