NCT02150317

Brief Summary

The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.

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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

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

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
2.5 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

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

May 26, 2014

Last Update Submit

March 28, 2016

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Carcinoma, HepatocellularChemoembolization, TherapeuticSorafenib

Outcome Measures

Primary Outcomes (1)

  • the overall survival rate of each group

    3 years

Study Arms (2)

TACE+Sorafenib

ACTIVE COMPARATOR

TACE followed by Sorafenib

Procedure: TACE+Sorafenib

TACE

EXPERIMENTAL

TACE alone

Procedure: TACE

Interventions

TACE+SorafenibPROCEDURE

TACE followed by Sorafenib

Also known as: TACE followed by Sorafenib
TACE+Sorafenib
TACEPROCEDURE

TACE alone

TACE

Eligibility Criteria

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

You may qualify if:

  • Male or female patients \> 18 years and \<=70 years of age.
  • at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
  • tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
  • Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  • No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
  • Hb ≥90g/L,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
  • Patients who can understand this trial and have signed information consent

You may not qualify if:

  • Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
  • Patients with other diseases which may affect the treatment mentioned.
  • Patients with a medical history of other malignant tumors.
  • Subjects participating in other clinical trials.
  • liver function:Child C.
  • no pathological evidence of hepatocellular carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, 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

  • Ai-jun Li, M.D.

    Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

    STUDY CHAIR

Central Study Contacts

Ai-jun Li, M.D.

CONTACT

0086-21-81875531yinlei409@hotmail.com

Lei Yin, M.D.

CONTACT

0086-21-81875532dermatology2008@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospital

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

CN(1)