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

NCT ID: NCT02150317

Last Updated: 2016-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TACE+Sorafenib

TACE followed by Sorafenib

Group Type ACTIVE_COMPARATOR

TACE+Sorafenib

Intervention Type PROCEDURE

TACE followed by Sorafenib

TACE

TACE alone

Group Type EXPERIMENTAL

TACE

Intervention Type PROCEDURE

TACE alone

Interventions

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TACE+Sorafenib

TACE followed by Sorafenib

Intervention Type PROCEDURE

TACE

TACE alone

Intervention Type PROCEDURE

Other Intervention Names

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TACE followed by Sorafenib

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ai-jun Li, M.D.

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

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Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ai-jun Li, M.D.

Role: CONTACT

0086-21-81875531

Lei Yin, M.D.

Role: CONTACT

0086-21-81875532

Facility Contacts

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Ai-jun Li, M.D.

Role: primary

0086-021-81875531

Lei Yin, M.D.

Role: backup

0086-021-81875532

Other Identifiers

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EHBHKY2013-001-08

Identifier Type: -

Identifier Source: org_study_id

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