TACE and Sorafenib for Advanced Hepatocellular Carcinoma... | NCT00618384

Studies
TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

NCT00618384

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Terminated

Last Update Posted

Jun 7, 2012Estimated

Enrollment

43Actual

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Sorafenib

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

May 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Feb 8, 2008

First Submission Date that Met QC Criteria

Feb 8, 2008

First Posted Date

Feb 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2012

Last Update Posted Date

Jun 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

For patients with advanced HCC not suitable for resection or liver transplantation but without extrahepatic manifestations, local therapy with TACE is regarded as standard treatment. The present study is planned to evaluate the combination of TACE and sorafenib. A combination of TACE with a multitarget inhibitor like sorafenib may further improve the outcome of patients with HCC.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Patients with TACE therapy will be treated with Sorafenib (2 x 400 mg/day) until progressive disease	Drug: Sorafenib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib	Drug	patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease	1

Measure	Description	Time Frame
determination of time to progression (TTP)		every 30 days after administration

Measure	Description	Time Frame
adverse events		3-week-periods

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

with histologically confirmed HCC not suitable for resection or liver transplantation
Patients with measurable disease according to RECIST
Performance status ECOG 0-2
Normal organ and bone marrow function (defined)
Women of childbearing potential must have performed a negative serum pregnancy test
male or female patients must use an approved contraceptive method during treatment and for 3 months after end of treatment after the end of treatment with study medication
Written informed consent

Exclusion Criteria:

Patient is eligible for liver resection or liver transplantation
Extrahepatic tumor manifestation
Thrombosis of the portal vein
> 8 points according to Child Pugh classification
Prior TACE or RFTA or any other local ablative treatment
Prior systemic anticancer chemotherapy or radiotherapy for HCC
Total bilirubin > 4.5 mg/dl
Life expectancy of less than 12 weeks
Esophageal varices grade III without prophylactic band ligation
Cardiac diseases (defined)
Uncontrolled hypertension
Known or suspected hyperthyroid state
Known brain metastasis
Patients with seizure disorder requiring medication
History of organ allograft
Active clinically serious infections > CTCAE grade 2
Thrombotic or embolic events
Hemorrhage/bleeding event (defined)
Acute variceal bleeding
Therapeutic anticoagulation with vitamin K antagonists (defined)
Known or suspected allergies to sorafenib, doxorubicin or lipiodol or any agent given in the course of this trial
Contraindications to the use of sorafenib, doxorubicin or lipiodol
Previous cancer distinct in primary site or histology from HCC (defined)
substance abuse
Participation in another clinical trial with any investigational study drug
Lactating women
Incapability to give valid informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
A. Erhardt, PD Dr.	Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Tübingen Innere Medizin I		Tübingen	Baden-Wurttemberg	72076	Germany
Medizinische Universitätsklinik Ulm Innere Medizin I

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25173458	Derived	Erhardt A, Kolligs F, Dollinger M, Schott E, Wege H, Bitzer M, Gog C, Lammert F, Schuchmann M, Walter C, Blondin D, Ohmann C, Haussinger D. TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial. Cancer Chemother Pharmacol. 2014 Nov;74(5):947-54. doi: 10.1007/s00280-014-2568-8. Epub 2014 Aug 31.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals