NCT02138981

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
436

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2014

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

6.3 years

First QC Date

May 13, 2014

Last Update Submit

July 31, 2018

Conditions

Resectable Hepatocellular Carcinoma Beyond Milan Criteria

Keywords

Hepatocellular CarcinomaMilan Criteria

Outcome Measures

Primary Outcomes (1)

  • overall survival time

    5 years

Secondary Outcomes (2)

  • disease free survival

    5 years

  • Number of Adverse Events

    30 days

Study Arms (2)

Immediate Resection

ACTIVE COMPARATOR

patients received immediate surgical hepatic resection

Procedure: Immediate Resection

Chemoembolization and Response-Dependent Resection

EXPERIMENTAL

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

Interventions

Chemoembolization and Response-Dependent ResectionPROCEDURE

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

Chemoembolization and Response-Dependent Resection
Immediate ResectionPROCEDURE

patients received immediate surgical resection.

Immediate Resection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Ming Shi, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Shi, MD

CONTACT

86-2087343154shiming@mail.sysu.edu.cn

Rong Ping Guo, MD

CONTACT

86-2087342266guorongp@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 15, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations

CN(1)