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Hepatectomy Versus Chemoembolization for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

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ClinicalTrials.gov Identifier: NCT02138981
Recruitment Status : Unknown
Verified July 2018 by Shi Ming, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 15, 2014
Last Update Posted : August 2, 2018
Sponsor:
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
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Resectable Hepatocellular Carcinoma Beyond Milan Criteria Procedure: Chemoembolization and Response-Dependent Resection Procedure: Immediate Resection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Resection Versus Transarterial Chemoembolization as the Initial Treatment for Resectable Hepatocellular Carcinoma Beyond Milan Criteria
Study Start Date : May 1, 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Active Comparator: Immediate Resection
patients received immediate surgical hepatic resection
Procedure: Immediate Resection
patients received immediate surgical resection.

Experimental: 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.
Procedure: 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.




Primary Outcome Measures :
  1. overall survival time [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: 5 years ]
  2. Number of Adverse Events [ Time Frame: 30 days ]
    All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138981


Contacts
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Contact: Ming Shi, MD 86-2087343154 shiming@mail.sysu.edu.cn
Contact: Rong Ping Guo, MD 86-2087342266 guorongp@mail.sysu.edu.cn

Locations
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China, Guangdong
Cancer Center Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ming Shi, MD    86-2087343115    shiming@mail.sysu.edu.cn   
Principal Investigator: Ming Shi, MD         
Sponsors and Collaborators
Sun Yat-sen University
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
Investigators
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Principal Investigator: Ming Shi, MD Sun Yat-sen University
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Responsible Party: Shi Ming, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02138981    
Other Study ID Numbers: HCC_S012
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Keywords provided by Shi Ming, Sun Yat-sen University:
Hepatocellular Carcinoma
Milan Criteria
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases