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Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma (TACE)

Primary Purpose

Advanced Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE+Sorafenib
TACE
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Sorafenib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Eastern Hepatobiliary Surgery HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TACE+Sorafenib

TACE

Arm Description

TACE followed by Sorafenib

TACE alone

Outcomes

Primary Outcome Measures

the overall survival rate of each group

Secondary Outcome Measures

Full Information

First Posted
May 26, 2014
Last Updated
March 28, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02150317
Brief Title
Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma
Acronym
TACE
Official Title
A Prospective Randomized Trial Comparing Transcatheter Arterial Chemoembolization (TACE) Followed by Sorafenib Versus TACE Alone for Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
Keywords
Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Sorafenib

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TACE+Sorafenib
Arm Type
Active Comparator
Arm Description
TACE followed by Sorafenib
Arm Title
TACE
Arm Type
Experimental
Arm Description
TACE alone
Intervention Type
Procedure
Intervention Name(s)
TACE+Sorafenib
Other Intervention Name(s)
TACE followed by Sorafenib
Intervention Description
TACE followed by Sorafenib
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
TACE alone
Primary Outcome Measure Information:
Title
the overall survival rate of each group
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ai-jun Li, M.D.
Phone
0086-21-81875531
Email
yinlei409@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Yin, M.D.
Phone
0086-21-81875532
Email
dermatology2008@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai-jun Li, M.D.
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ai-jun Li, M.D.
Phone
0086-021-81875531
Email
yinlei409@hotmail.com
First Name & Middle Initial & Last Name & Degree
Lei Yin, M.D.
Phone
0086-021-81875532
Email
dermatology2008@126.com

12. IPD Sharing Statement

Learn more about this trial

Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma

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