Hepatocellular CarcinomaPhase 3NCT00355862
Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma
A Phase 3 study testing CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free) and Sirolimus in people with Hepatocellular Carcinoma, run by University of Regensburg at 1 site in Germany.
Trial summary
The purpose of this study is to determine the safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival. 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?
- CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free) and Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to May 2014
- Phase
- Phase 3
- 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
- Age 18 years and older
- Histologically proven HCC before randomisation
- Signed, written informed consent
Who cannot join
- Multiple-organ recipients.
- Known hypersensitivity to sirolimus or its derivatives.
- Hyperlipidemia refractory to optimal medical management. (cholesterol >300 mg/dL; triglycerides >350 mg/dL).*
- Evidence of significant local or systemic infection.
- Known HIV-positive patients.*
- Platelets <75,000/cubic mm.*
Show all 11Show fewer
- Women of child-bearing potential not willing to take contraception.
- Patients with non-HCC malignancies within the past 5 years,excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin.
- Extrahepatic HCC tumor manifestation
- Patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
- Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised, Open-labeled, Trial Comparing Sirolimus-Containing Versus mTOR-Inhibitor-Free Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma
The purpose of this study is to determine the safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival.
Read the detailed description
There are two major issues to face in patients who underwent liver transplantation for hepatocellular carcinoma (HCC). First, the patient requires adequate immunosuppressive medication to avoid rejection of its allograft. Second, the risk for HCC recurrence has to be reduced to a minimum.
To date, it is a wide spread argument that immunosuppressive agents for the reduction of allograft rejection are generally tumorogenic, or at least are permissive of cancer development although little is known about their tumorogenic effect. In clinical studies substantiated by experimental data, cyclosporin (CsA) enhances cancer cell growth characteristics and angiogenesis in tumors and inhibits DNA repair mechanisms, promoting their growth. In an experimental rat-model CsA promoted liver tumor recurrence and growth. In other experimental studies a higher proliferation rate of human hepatoma cells in the presence of tacrolimus was demonstrated.
Nevertheless not all immunosuppressive agents do necessarily promote tumor growth, and in fact, can have antineoplastic activities. Sirolimus, in immunosuppressive doses, has potent antiangiogenic properties that inhibit tumor growth. The antiangiogenetic mechanism is due to inhibition of vascular endothelial growth factor (VEGF) production and signaling to endothelial cells. Besides that, sirolimus directly blocks critical intracellular pathways (mTOR) and inhibits cell-cycle. Through increased E-cadherin expression on tumor cells, tumor metastasis can be reduced by increased tumor cell binding.
In this context it has to be mentioned that in mouse models where a transplant recipient also has a tumor, the pro-tumor effects of CsA are completely negated by sirolimus.
Especially HCC seems to be particularly sensitive to VEGF/angiogenesis, indicating a potential susceptibility to the action of sirolimus which could be shown by the group of E.K. Geissler and colleagues in Regensburg.
From a clinical perspective there is a recent pilot study from Kneteman et al. indicating that early conversion of immunosuppression from CNI to mTOR-inhibitors after OLT in HCC patients (n=21) with a "high risk" for tumor recurrence results in a tumor recurrence rate of only 19% and a 4-year over all survival of 83% in this group. Moreover, in the "low-risk" group (n=19) the 4-year tumor recurrence rate was only 1/19. Post-HCC recurrence survival was 15.5 months, which is marked improvement compared to currently published data. Although this study only reports on a small number of patients and is not controlled, it suggests the potential role for sirolimus to ameliorate tumor recurrence, leading to a more benign course of renewed tumor disease.
Among the most serious complications of immunosuppressive therapy in organ transplantation is the high risk of previous neoplasia recurrence, or the development of de novo cancer. HCC comprises 80-90 % of malignancies indicating OLT. Before the introduction of strict criteria for the enrollment of primary liver tumors, tumor recurrence led to poor mid- and long-term results. HCC thus has an unacceptable recurrence rate following OLT when the tumor exceeds 5 cm in size. ELTR data from 2003 showed a 5 year patient overall survival for hepatic malignancy (including more than 80% HCC in this group since 1997) of merely 53%, comparing poorly with data from non-cholestatic liver cirrhosis of 74% and even acute liver failure of 62%. Based on previous work, and a landmark publication in 1996 by Mazzaferro et al. many centers have restricted their indication for liver transplantation due to clinical criteria based on tumor size and number to the so-called ´Milan Criteria´.
Implementing these criteria, recent single center data show an improvement in both disease-free and overall survival following OLT for HCC. Nevertheless approximately 30% of patients in these studies who were thought to be within Milan Criteria before transplantation, proved by histopathological examination to have extended disease. This led to a dramatic decline in overall and disease-free survival, from 71-85% to 40-50%, and from 65-78% to 27-30%, respectively.
In total all preclinical and clinical observations have led us to the purpose that the use of sirolimus in HCC patients could improve survival after liver transplantation by decreasing tumor recurrence rate. Thus patients should experience less posttransplant problems with HCC recurrence, and therefore could expect a longer, and better quality of life.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free), Sirolimus
- Keywords
- Sirolimus, mTOR, HCC-recurrence free survival, Liver transplant recipients, HCC recurrence free survival
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free)Drug
Also called Cyclosporine, Tacrolimus, Azathioprine, MMF
center specific therapeutic regimen without mTOR inhibition
SirolimusDrug
Also called Rapamune
Sirolimus based immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Center specific immunosuppressive regimen (mTOR inhibitor free) Receives: Drug: CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free) |
| 2 | Experimental | Sirolimus containing regimen Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Measured: 5 year follow up after last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2009
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Investigators
- Edward K Geissler, Prof. PhD, Study chair, Regensburg University Medical Center, Head of Experimental SurgeryHans J Schlitt, Prof. MD. FACS FRACS FRCS MHM, Study director, Regensburg University Medical Center, Director of Surgical DepartmentAndreas A Schnitzbauer, MD, Principal investigator, Regensburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355862
- Sponsor's protocol ID
- SiLVER05
- Other IDs
- EudraCT Number:, 2005-005362-36, 2005
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2006
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schnitzbauer AA, Filmann N, Adam R, Bachellier P, Bechstein WO, Becker T, Bhoori S, Bilbao I, Brockmann J, Burra P, Chazoullieres O, Cillo U, Colledan M, Duvoux C, Ganten TM, Gugenheim J, Heise M, van Hoek B, Jamieson N, de Jong KP, Klein CG, Klempnauer J, Kneteman N, Lerut J, Makisalo H, Mazzaferro V, Mirza DF, Nadalin S, Neuhaus P, Pageaux GP, Pinna AD, Pirenne J, Pratschke J, Powel J, Rentsch M, Rizell M, Rossi G, Rostaing L, Roy A, Scholz T, Settmacher U, Soliman T, Strasser S, Soderdahl G, Troisi RI, Turrion VS, Schlitt HJ, Geissler EK. mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors. Ann Surg. 2020 Nov;272(5):855-862. doi: 10.1097/SLA.0000000000004280.
PubMed 32889867Geissler EK, Schnitzbauer AA, Zulke C, Lamby PE, Proneth A, Duvoux C, Burra P, Jauch KW, Rentsch M, Ganten TM, Schmidt J, Settmacher U, Heise M, Rossi G, Cillo U, Kneteman N, Adam R, van Hoek B, Bachellier P, Wolf P, Rostaing L, Bechstein WO, Rizell M, Powell J, Hidalgo E, Gugenheim J, Wolters H, Brockmann J, Roy A, Mutzbauer I, Schlitt A, Beckebaum S, Graeb C, Nadalin S, Valente U, Turrion VS, Jamieson N, Scholz T, Colledan M, Fandrich F, Becker T, Soderdahl G, Chazouilleres O, Makisalo H, Pageaux GP, Steininger R, Soliman T, de Jong KP, Pirenne J, Margreiter R, Pratschke J, Pinna AD, Hauss J, Schreiber S, Strasser S, Klempnauer J, Troisi RI, Bhoori S, Lerut J, Bilbao I, Klein CG, Konigsrainer A, Mirza DF, Otto G, Mazzaferro V, Neuhaus P, Schlitt HJ. Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial. Transplantation. 2016 Jan;100(1):116-25. doi: 10.1097/TP.0000000000000965.
PubMed 26555945Schnitzbauer AA, Zuelke C, Graeb C, Rochon J, Bilbao I, Burra P, de Jong KP, Duvoux C, Kneteman NM, Adam R, Bechstein WO, Becker T, Beckebaum S, Chazouilleres O, Cillo U, Colledan M, Fandrich F, Gugenheim J, Hauss JP, Heise M, Hidalgo E, Jamieson N, Konigsrainer A, Lamby PE, Lerut JP, Makisalo H, Margreiter R, Mazzaferro V, Mutzbauer I, Otto G, Pageaux GP, Pinna AD, Pirenne J, Rizell M, Rossi G, Rostaing L, Roy A, Turrion VS, Schmidt J, Troisi RI, van Hoek B, Valente U, Wolf P, Wolters H, Mirza DF, Scholz T, Steininger R, Soderdahl G, Strasser SI, Jauch KW, Neuhaus P, Schlitt HJ, Geissler EK. A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma. BMC Cancer. 2010 May 11;10:190. doi: 10.1186/1471-2407-10-190.
PubMed 20459775Geissler EK. Rapamycin enhances lifespan: at last, an advantage for transplant recipients? Nephrol Dial Transplant. 2009 Dec;24(12):3623-5. doi: 10.1093/ndt/gfp496. Epub 2009 Sep 22. No abstract available.
PubMed 19773418Treiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61. doi: 10.1586/14737140.9.2.247.
PubMed 19192962
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised, Open-labeled, Trial Comparing Sirolimus-Containing Versus mTOR-Inhibitor-Free Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00355862
- Acronym / sponsor ID
- SiLVER05
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Sirolimus, mTOR, HCC-recurrence free survival, Liver transplant recipients, HCC recurrence free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Jul 2006 (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 safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival.
Detailed description
There are two major issues to face in patients who underwent liver transplantation for hepatocellular carcinoma (HCC). First, the patient requires adequate immunosuppressive medication to avoid rejection of its allograft. Second, the risk for HCC recurrence has to be reduced to a minimum.
To date, it is a wide spread argument that immunosuppressive agents for the reduction of allograft rejection are generally tumorogenic, or at least are permissive of cancer development although little is known about their tumorogenic effect. In clinical studies substantiated by experimental data, cyclosporin (CsA) enhances cancer cell growth characteristics and angiogenesis in tumors and inhibits DNA repair mechanisms, promoting their growth. In an experimental rat-model CsA promoted liver tumor recurrence and growth. In other experimental studies a higher proliferation rate of human hepatoma cells in the presence of tacrolimus was demonstrated.
Nevertheless not all immunosuppressive agents do necessarily promote tumor growth, and in fact, can have antineoplastic activities. Sirolimus, in immunosuppressive doses, has potent antiangiogenic properties that inhibit tumor growth. The antiangiogenetic mechanism is due to inhibition of vascular endothelial growth factor (VEGF) production and signaling to endothelial cells. Besides that, sirolimus directly blocks critical intracellular pathways (mTOR) and inhibits cell-cycle. Through increased E-cadherin expression on tumor cells, tumor metastasis can be reduced by increased tumor cell binding.
In this context it has to be mentioned that in mouse models where a transplant recipient also has a tumor, the pro-tumor effects of CsA are completely negated by sirolimus.
Especially HCC seems to be particularly sensitive to VEGF/angiogenesis, indicating a potential susceptibility to the action of sirolimus which could be shown by the group of E.K. Geissler and colleagues in Regensburg.
From a clinical perspective there is a recent pilot study from Kneteman et al. indicating that early conversion of immunosuppression from CNI to mTOR-inhibitors after OLT in HCC patients (n=21) with a "high risk" for tumor recurrence results in a tumor recurrence rate of only 19% and a 4-year over all survival of 83% in this group. Moreover, in the "low-risk" group (n=19) the 4-year tumor recurrence rate was only 1/19. Post-HCC recurrence survival was 15.5 months, which is marked improvement compared to currently published data. Although this study only reports on a small number of patients and is not controlled, it suggests the potential role for sirolimus to ameliorate tumor recurrence, leading to a more benign course of renewed tumor disease.
Among the most serious complications of immunosuppressive therapy in organ transplantation is the high risk of previous neoplasia recurrence, or the development of de novo cancer. HCC comprises 80-90 % of malignancies indicating OLT. Before the introduction of strict criteria for the enrollment of primary liver tumors, tumor recurrence led to poor mid- and long-term results. HCC thus has an unacceptable recurrence rate following OLT when the tumor exceeds 5 cm in size. ELTR data from 2003 showed a 5 year patient overall survival for hepatic malignancy (including more than 80% HCC in this group since 1997) of merely 53%, comparing poorly with data from non-cholestatic liver cirrhosis of 74% and even acute liver failure of 62%. Based on previous work, and a landmark publication in 1996 by Mazzaferro et al. many centers have restricted their indication for liver transplantation due to clinical criteria based on tumor size and number to the so-called ´Milan Criteria´.
Implementing these criteria, recent single center data show an improvement in both disease-free and overall survival following OLT for HCC. Nevertheless approximately 30% of patients in these studies who were thought to be within Milan Criteria before transplantation, proved by histopathological examination to have extended disease. This led to a dramatic decline in overall and disease-free survival, from 71-85% to 40-50%, and from 65-78% to 27-30%, respectively.
In total all preclinical and clinical observations have led us to the purpose that the use of sirolimus in HCC patients could improve survival after liver transplantation by decreasing tumor recurrence rate. Thus patients should experience less posttransplant problems with HCC recurrence, and therefore could expect a longer, and better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free)Center specific immunosuppressive regimen (mTOR inhibitor free) |
| 2 | Experimental | Drug: SirolimusSirolimus containing regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and older
- Histologically proven HCC before randomisation
- Signed, written informed consent
Key exclusion criteria (11 listed)
- Multiple-organ recipients.
- Known hypersensitivity to sirolimus or its derivatives.
- Hyperlipidemia refractory to optimal medical management. (cholesterol >300 mg/dL; triglycerides >350 mg/dL).*
- Evidence of significant local or systemic infection.
- Known HIV-positive patients.*
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 |
|---|---|---|
| CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free)Also: Cyclosporine, Tacrolimus, Azathioprine, MMFcenter specific therapeutic regimen without mTOR inhibition | Drug | 1 |
| SirolimusAlso: RapamuneSirolimus based immunosuppression | Drug | 2 |
Primary outcome
Recurrence free survival
Time frame: 5 year follow up after last patient in
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 30 Jul 2014.
- Derived from this study: PubMed 32889867Schnitzbauer AA, Filmann N, Adam R, Bachellier P, Bechstein WO, Becker T, Bhoori S, Bilbao I, Brockmann J, Burra P, Chazoullieres O, Cillo U, Colledan M, Duvoux C, Ganten TM, Gugenheim J, Heise M, van Hoek B, Jamieson N, de Jong KP, Klein CG, Klempnauer J, Kneteman N, Lerut J, Makisalo H, Mazzaferro V, Mirza DF, Nadalin S, Neuhaus P, Pageaux GP, Pinna AD, Pirenne J, Pratschke J, Powel J, Rentsch M, Rizell M, Rossi G, Rostaing L, Roy A, Scholz T, Settmacher U, Soliman T, Strasser S, Soderdahl G, Troisi RI, Turrion VS, Schlitt HJ, Geissler EK. mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors. Ann Surg. 2020 Nov;272(5):855-862. doi: 10.1097/SLA.0000000000004280.
- Derived from this study: PubMed 26555945Geissler EK, Schnitzbauer AA, Zulke C, Lamby PE, Proneth A, Duvoux C, Burra P, Jauch KW, Rentsch M, Ganten TM, Schmidt J, Settmacher U, Heise M, Rossi G, Cillo U, Kneteman N, Adam R, van Hoek B, Bachellier P, Wolf P, Rostaing L, Bechstein WO, Rizell M, Powell J, Hidalgo E, Gugenheim J, Wolters H, Brockmann J, Roy A, Mutzbauer I, Schlitt A, Beckebaum S, Graeb C, Nadalin S, Valente U, Turrion VS, Jamieson N, Scholz T, Colledan M, Fandrich F, Becker T, Soderdahl G, Chazouilleres O, Makisalo H, Pageaux GP, Steininger R, Soliman T, de Jong KP, Pirenne J, Margreiter R, Pratschke J, Pinna AD, Hauss J, Schreiber S, Strasser S, Klempnauer J, Troisi RI, Bhoori S, Lerut J, Bilbao I, Klein CG, Konigsrainer A, Mirza DF, Otto G, Mazzaferro V, Neuhaus P, Schlitt HJ. Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial. Transplantation. 2016 Jan;100(1):116-25. doi: 10.1097/TP.0000000000000965.
- Derived from this study: PubMed 20459775Schnitzbauer AA, Zuelke C, Graeb C, Rochon J, Bilbao I, Burra P, de Jong KP, Duvoux C, Kneteman NM, Adam R, Bechstein WO, Becker T, Beckebaum S, Chazouilleres O, Cillo U, Colledan M, Fandrich F, Gugenheim J, Hauss JP, Heise M, Hidalgo E, Jamieson N, Konigsrainer A, Lamby PE, Lerut JP, Makisalo H, Margreiter R, Mazzaferro V, Mutzbauer I, Otto G, Pageaux GP, Pinna AD, Pirenne J, Rizell M, Rossi G, Rostaing L, Roy A, Turrion VS, Schmidt J, Troisi RI, van Hoek B, Valente U, Wolf P, Wolters H, Mirza DF, Scholz T, Steininger R, Soderdahl G, Strasser SI, Jauch KW, Neuhaus P, Schlitt HJ, Geissler EK. A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma. BMC Cancer. 2010 May 11;10:190. doi: 10.1186/1471-2407-10-190.
- Derived from this study: PubMed 19773418Geissler EK. Rapamycin enhances lifespan: at last, an advantage for transplant recipients? Nephrol Dial Transplant. 2009 Dec;24(12):3623-5. doi: 10.1093/ndt/gfp496. Epub 2009 Sep 22. No abstract available.
- Derived from this study: PubMed 19192962Treiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61. doi: 10.1586/14737140.9.2.247.
- Related InfoLink provided by the sponsor.
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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.
Edward K Geissler, Prof. PhD study chair
Regensburg University Medical Center, Head of Experimental Surgery
Hans J Schlitt, Prof. MD. FACS FRACS FRCS MHM study director
Regensburg University Medical Center, Director of Surgical Department
Andreas A Schnitzbauer, MD principal investigator
Regensburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CNI, MMF, Steroids, Aza etc. (mTOR inhibitor free) and Sirolimus in people with Hepatocellular Carcinoma, run by University of Regensburg at 1 site 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 3 inclusion and 11 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 30 Jul 2014. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Recurrence free survival (time frame: 5 year follow up after last patient in). 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 NCT00355862, which also lists 5 linked publications.
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 30 Jul 2014.