NCT02038296

Brief Summary

To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

5.2 years

First QC Date

January 15, 2014

Last Update Submit

January 16, 2014

Conditions

Liver Cancer

Keywords

Hepatocellular carcinomaTransarterial chemoembolizationGemcitabine

Outcome Measures

Primary Outcomes (1)

  • overall survival

    1-2 year

Study Arms (3)

Group 1

EXPERIMENTAL

Group 1 received single-drug (doxorubicin)transarterial chemoembolization.

Procedure: transarterial chemoembolization

Group 2

EXPERIMENTAL

Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization

Procedure: transarterial chemoembolization

Group 3

EXPERIMENTAL

Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization.

Procedure: transarterial chemoembolization

Interventions

transarterial chemoembolizationPROCEDURE
Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;
  • HCC with no previous treatment;
  • age between 18 and 75 years;
  • Life expectancy of at least 8 weeks;
  • main tumor size greater than 5 cm;
  • adequate hematologic function (platelet count: \>60 × 109 platelets/L; hemoglobin: \>90g/L; and prothrombin time: \<3 seconds above control);
  • adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
  • Child-Pugh classification A or B grade;
  • Barcelona Clinic Liver Cancer (BCLC) stage B or C;
  • Eastern Co-operative Group performance status of zero or one.

You may not qualify if:

  • a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
  • diffuse-type HCC;
  • evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
  • severe underlying cardiac or renal diseases;
  • color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 16, 2014

Study Start

January 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

CN(1)