NCT01857726

Brief Summary

The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

May 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

3.4 years

First QC Date

May 13, 2013

Last Update Submit

April 27, 2016

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomaportal vein invasiontransarterial chemoembolizationtransarterial chemoinfusion

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    every 12 weeks, up to 48 weeks

Secondary Outcomes (2)

  • Time-to-progression

    every 12 weeks, up to 48 weeks

  • Progression-free survival

    every 12 weeks, up to 48 weeks

Study Arms (2)

The TACE/TACI combination group

EXPERIMENTAL

Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination

Drug: DoxorubicinDrug: Cisplatin

The TACE-only group

ACTIVE COMPARATOR

Transarterial chemoembolization with doxorubicin

Drug: Doxorubicin

Interventions

DoxorubicinDRUG

Transarterial chemoembolization (TACE) with adriamycin

Also known as: Adriamycin
The TACE-only groupThe TACE/TACI combination group
CisplatinDRUG

transarterial chemoinfusion with cisplatin 50-100 mg

The TACE/TACI combination group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
  • Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI
  • Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible
  • Age : 18 years to 80 years
  • ECOG Performance Status of 0 to 2
  • Child-Pugh class A (Child-Pugh score 5-6)
  • Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  • WBC count \> 2,000/mm3
  • Absolute neutrophil count \> 1,000/mm3
  • Hb ≧ 8.0 g/dL
  • Platelet count ≧ 50,000 /mm3
  • Bilirubin ≦ 3 mg/dL
  • Adequate clotting function: INR \< 2.3 or \< 6sec

You may not qualify if:

  • Child-Pugh score ≧ 7
  • ECOG Performance Status ≧ 3
  • Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
  • History of organ allograft
  • Patients with uncontrolled co-morbidity which needs treatment
  • Patients who have received prior systemic chemotherapy
  • Patients with extrahepatic metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

DoxorubicinCisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Jung-Hwan Yoon, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
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, 2013

First Posted

May 20, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

KR(1)