- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150317
Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma (TACE)
March 28, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital
A Prospective Randomized Trial Comparing Transcatheter Arterial Chemoembolization (TACE) Followed by Sorafenib Versus TACE Alone for Advanced Hepatocellular Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ai-jun Li, M.D.
- Phone Number: 0086-21-81875531
- Email: yinlei409@hotmail.com
Study Contact Backup
- Name: Lei Yin, M.D.
- Phone Number: 0086-21-81875532
- Email: dermatology2008@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200438
- Recruiting
- Eastern Hepatobiliary Surgery Hospital
-
Contact:
- Ai-jun Li, M.D.
- Phone Number: 0086-021-81875531
- Email: yinlei409@hotmail.com
-
Contact:
- Lei Yin, M.D.
- Phone Number: 0086-021-81875532
- Email: dermatology2008@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TACE+Sorafenib
TACE followed by Sorafenib
|
TACE followed by Sorafenib
Other Names:
|
Experimental: TACE
TACE alone
|
TACE alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the overall survival rate of each group
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ai-jun Li, M.D., Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
May 26, 2014
First Submitted That Met QC Criteria
May 26, 2014
First Posted (Estimate)
May 29, 2014
Study Record Updates
Last Update Posted (Estimate)
March 29, 2016
Last Update Submitted That Met QC Criteria
March 28, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens, Non-Steroidal
- Estrogens
- Protein Kinase Inhibitors
- Chlorotrianisene
- Sorafenib
Other Study ID Numbers
- EHBHKY2013-001-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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