Hepatocellular CarcinomaPhase 2SOCRATESNCT00618384
TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)
A Phase 2 study testing Sorafenib in people with Hepatocellular Carcinoma, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 6 sitesGermany
- Study dates
- Jan 2008to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Klinikum der Johann-Goethe-Universität
Frankfurt am Main, Hesse, 60590
Universitätsklinikum Hamburg-Eppendorf Zentrum für Innere Medizin
Hamburg, Free and Hanseatic City of Hamburg, 20246
Johannes-Gutenberg-Universität Medizinische Klinik
Mainz, Rhineland-Palatinate, 55131
Klinikum der Universität Großhardern
Munich, Bavaria, 81377
Universitätsklinikum Tübingen Innere Medizin I
Tübingen, Baden-Wurttemberg, 72076
Medizinische Universitätsklinik Ulm Innere Medizin I
Ulm, Baden-Wurttemberg, 89081
About this study
Official title: Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib
- Keywords
- TACE, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients with TACE therapy will be treated with Sorafenib (2 x 400 mg/day) until progressive disease Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of time to progression (TTP)
Measured: every 30 days after administration
Secondary outcomes (1)
adverse events
Measured: 3-week-periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. Erhardt, PD Dr., Principal investigator, Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618384
- Sponsor's protocol ID
- SOCRATES-072
- Acronym
- SOCRATES
- Status last verified
- Jun 2012
- First submitted
- 8 Feb 2008
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25173458
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00618384
- Acronym / sponsor ID
- SOCRATES / SOCRATES-072
- Conditions
- Hepatocellular Carcinoma
- Keywords
- TACE, hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: SorafenibPatients with TACE therapy will be treated with Sorafenib (2 x 400 mg/day) until progressive disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibAlso: Nexavarpatients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease | Drug | 1 |
Primary outcome
determination of time to progression (TTP)
Time frame: every 30 days after administration
1 secondary outcome
adverse events
Time frame: 3-week-periods
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- Derived from this study: PubMed 25173458Erhardt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Erhardt, PD Dr. principal investigator
Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib in people with Hepatocellular Carcinoma, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of time to progression (TTP) (time frame: every 30 days after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00618384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.