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TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC) (SOCRATES)

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Sorafenib
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring TACE, hepatocellular carcinoma

Eligibility Criteria

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

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

Sites / Locations

  • Universitätsklinikum Tübingen Innere Medizin I
  • Medizinische Universitätsklinik Ulm Innere Medizin I
  • Klinikum der Universität Großhardern
  • Klinikum der Johann-Goethe-Universität
  • Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin
  • Johannes-Gutenberg-Universität Medizinische Klinik

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Patients with TACE therapy will be treated with Sorafenib (2 x 400 mg/day) until progressive disease

Outcomes

Primary Outcome Measures

determination of time to progression (TTP)

Secondary Outcome Measures

adverse events

Full Information

First Posted
February 8, 2008
Last Updated
June 6, 2012
Sponsor
Heinrich-Heine University, Duesseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT00618384
Brief Title
TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)
Acronym
SOCRATES
Official Title
Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
TACE, hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients with TACE therapy will be treated with Sorafenib (2 x 400 mg/day) until progressive disease
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease
Primary Outcome Measure Information:
Title
determination of time to progression (TTP)
Time Frame
every 30 days after administration
Secondary Outcome Measure Information:
Title
adverse events
Time Frame
3-week-periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Erhardt, PD Dr.
Organizational Affiliation
Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Tübingen Innere Medizin I
City
Tübingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
Facility Name
Medizinische Universitätsklinik Ulm Innere Medizin I
City
Ulm
State/Province
BW
ZIP/Postal Code
89081
Country
Germany
Facility Name
Klinikum der Universität Großhardern
City
Muenchen
State/Province
BY
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum der Johann-Goethe-Universität
City
Frankfurt
State/Province
HE
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin
City
Hamburg
State/Province
HH
ZIP/Postal Code
20246
Country
Germany
Facility Name
Johannes-Gutenberg-Universität Medizinische Klinik
City
Mainz
State/Province
RP
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25173458
Citation
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.
Results Reference
derived

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TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

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