Hepatocellular CarcinomaPhase 1S-TACENCT00478374
Sorafenib With TACE to Treat Hepatocellular Carcinoma
A Phase 1 study testing Sorafenib and Transarterial chemoembolisation with doxorubicin in people with Hepatocellular Carcinoma, run by University of Bern at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine the feasibility to combine sorafenib with transarterial chemoembolisation in patients suffering from hepatocellular carcinoma.The hypothesis is that sorafenib may prevent the development and growth of tumoral lesions not treated by chemoembolisation. 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 and Transarterial chemoembolisation with doxorubicin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2007to Jan 2009
- Phase
- Phase 1
- 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
- Patients with inoperable HCC, who are candidates for transarterial chemoembolization (TACE).
- Diagnosis of hepatocellular carcinoma based on the EASL's criteria (1).
- Child-Pugh score < 10 (Child A or B),
- Life expectancy superior to 12 weeks at the pre-treatment evaluation.
- Local therapies have been interrupted for at least 4 weeks
- Written informed consent signed
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- Age >= 18
- Performance status ECOG 0-1
- Normal organ and marrow function defined as:
- Haematopoietic: absolute neutrophil count >1,500/mm3, platelet count > 60,000/mm3, haemoglobin > 9g/dL
- INR < 1.5 ULN and PTT within normal limits
- Hepatic: AST or ALT < 5 x ULN
- Renal: creatinine < 1.5 x ULN
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate birth contraception (must be double and methods recorded) prior to study entry and for the duration of the study participation. For both men and women, these adequate birth control measures must be used for at least 3 months after the last administration of study drug.
Who cannot join
- Active heart disease is defined as congestive heart failure >NYHA (New York Heart Association) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted) or uncontrolled hypertension.
- Congestive heart failure, serious cardiac arrhythmia, active coronary artery disease.
- Thrombotic or embolic events within the past 6 months such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with evidence of active infection will become eligible for reconsideration 7 days after completing antibiotic therapy.
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- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.
- Patients who have been treated with sorafenib.
- Cerebral metastasis.
- Child-Pugh score C.
- Hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg despite optimal medical management.
- Proteinuria defined as a 24-hour urine protein excretion greater than 1000 mg. Urine dipstick proteinuria of 1+ or greater will require a 24-hour urine to determine eligibility for enrolment.
- Therapeutic anticoagulation with coumarin, heparins, or heparinoids.
- Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months of fracture.
- Evidence of bleeding diathesis.
- Impairment of swallowing that would preclude administration of sorafenib.
- History of haemoptysis or surgery within the past 28 days.
- Organ allograft.
- Pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transarterial Chemoembolisation With Doxorubicin in Combination With Systemic Administration of Sorafenib for Patients With Hepatocellular Carcinoma
The purpose of this study is to determine the feasibility to combine sorafenib with transarterial chemoembolisation in patients suffering from hepatocellular carcinoma.The hypothesis is that sorafenib may prevent the development and growth of tumoral lesions not treated by chemoembolisation.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib, Transarterial chemoembolisation with doxorubicin
- 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
Sorafenib 400mg bid
Transarterial chemoembolisation with doxorubicinProcedure or surgery
Transarterial chemoembolisation (TACE)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Sorafenib; Procedure: Transarterial chemoembolisation with doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of the administration of sorafenib in patients with hepatocellular carcinoma treated with TACE by determining the MTD.
Measured: 2 years
Secondary outcomes (2)
tumor volumetry
Measured: 2 years
changes in the blood concentration of tumor marker AFP
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2009
- Study completionJan 2009
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 University of BernThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Candinas, Principal investigator, InselspitalMarkus Borner, Principal investigator, InselspitalJean-François J Dufour, MD, Study director, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478374
- Sponsor's protocol ID
- JFD-12581
- Acronym
- S-TACE
- Status last verified
- Nov 2010
- First submitted
- 23 May 2007
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Dufour JF, Hoppe H, Heim MH, Helbling B, Maurhofer O, Szucs-Farkas Z, Kickuth R, Borner M, Candinas D, Saar B. Continuous administration of sorafenib in combination with transarterial chemoembolization in patients with hepatocellular carcinoma: results of a phase I study. Oncologist. 2010;15(11):1198-204. doi: 10.1634/theoncologist.2010-0180. Epub 2010 Oct 29.
PubMed 21036880
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolisation With Doxorubicin in Combination With Systemic Administration of Sorafenib for Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00478374
- Acronym / sponsor ID
- S-TACE / JFD-12581
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 24 May 2007 (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.
The purpose of this study is to determine the feasibility to combine sorafenib with transarterial chemoembolisation in patients suffering from hepatocellular carcinoma.The hypothesis is that sorafenib may prevent the development and growth of tumoral lesions not treated by chemoembolisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sorafenib, Procedure: Transarterial chemoembolisation with doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with inoperable HCC, who are candidates for transarterial chemoembolization (TACE).
- Diagnosis of hepatocellular carcinoma based on the EASL's criteria (1).
- Child-Pugh score < 10 (Child A or B),
- Life expectancy superior to 12 weeks at the pre-treatment evaluation.
- Local therapies have been interrupted for at least 4 weeks
Key exclusion criteria (19 listed)
- Active heart disease is defined as congestive heart failure >NYHA (New York Heart Association) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted) or uncontrolled hypertension.
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 |
|---|---|---|
| SorafenibSorafenib 400mg bid | Drug | 1 |
| Transarterial chemoembolisation with doxorubicinTransarterial chemoembolisation (TACE) | Procedure or surgery | 1 |
Primary outcome
To assess the safety and tolerability of the administration of sorafenib in patients with hepatocellular carcinoma treated with TACE by determining the MTD.
Time frame: 2 years
2 secondary outcomes
tumor volumetry
Time frame: 2 years
changes in the blood concentration of tumor marker AFP
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
- Results publication: PubMed 21036880Dufour JF, Hoppe H, Heim MH, Helbling B, Maurhofer O, Szucs-Farkas Z, Kickuth R, Borner M, Candinas D, Saar B. Continuous administration of sorafenib in combination with transarterial chemoembolization in patients with hepatocellular carcinoma: results of a phase I study. Oncologist. 2010;15(11):1198-204. doi: 10.1634/theoncologist.2010-0180. Epub 2010 Oct 29.
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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.
Daniel Candinas principal investigator
Inselspital
Markus Borner principal investigator
Inselspital
Jean-François J Dufour, MD study director
Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib and Transarterial chemoembolisation with doxorubicin in people with Hepatocellular Carcinoma, run by University of Bern at 1 site in Switzerland.
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 15 inclusion and 19 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: finished, as of the sponsor's last update on 2 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the safety and tolerability of the administration of sorafenib in patients with hepatocellular carcinoma treated with TACE by determining the MTD. (time frame: 2 years). 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 NCT00478374, 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 2 Nov 2010.