Carcinoma, HepatocellularNCT01387503
Expansion of Conventional Criteria for Liver Transplantation in Hepatocellular Carcinoma Through Downstaging
A study testing Liver transplantation in people with Carcinoma, Hepatocellular and Cirrhosis, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 10 sites in Italy.
Trial summary
This clinical trial is aimed at extending the chance of liver transplantation, through downstaging procedures, to patients with hepatocellular carcinoma (HCC) exceeding conventional Milan Criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Cirrhosis
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 10 sitesItaly
- Study dates
- Jan 2011to 31 Jul 2019
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's age ≥ 18 yrs and ≤ 65 yrs
- Presence of cirrhosis of any etiology
- Child-Pugh class ≤ B7
- ECOG Performance Status ≤ 1
- Diagnosis of HCC either by biopsy or according to AASLD criteria
- HCC exceeding Milan Criteria with a 5-yr estimated survival after transplantation >50% according to the Metroticket calculator (http://www.hcc-olt-metroticket.org/calculator)
- Women of child bearing potential with a negative serum pregnancy test performed before enrolment
- Absence of general contraindications to sorafenib/molecular targeted therapies
Who cannot join
- Presence of extra-hepatic tumor spread
- Presence of macrovascular invasion
- Sorafenib therapy started > 2 months before enrolment
- Concurrent cancer, distinct from HCC (except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors)
- Previous history of any cancer, even if curatively treated, < 5 years prior to entry
- Active intra-venous or alcohol abusers
Show all 10Show fewer
- HIV infection
- History of serious cardiac disease
- Severe pulmonary hypertension not treatable by medical therapy
- Patients with a life expectancy of less than 3 months due to HCC or less than 6 months due to any other disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Ospedali Riuniti di Bergamo
Bergamo, 24125
Ospedale Maggiore di Milano Policlinico
Milan, 20122
Istituto Nazionale Tumori
Milan, 20133
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, 20162
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
Palermo, 90133
Policlinico Tor Vergata
Roma, 00133
Ospedale "Lazzaro Spallanzani"
Roma, 00149
Ospedale Umberto Iº Policlinico di Roma
Roma, 00161
Ospedale Universitario Molinette S. Giovanni Battista di Torino
Torino, 10126
About this study
Official title: Controlled Expansion of Conventional Criteria for Liver Transplantation in Hepatocellular Carcinoma Through Downstaging Procedures: a Randomized Trial (XXL Trial)
This clinical trial is aimed at extending the chance of liver transplantation, through downstaging procedures, to patients with hepatocellular carcinoma (HCC) exceeding conventional Milan Criteria.
Those patients that will achieve a sustained tumor response after downstaging will be randomized either to undergo liver transplantation or to proceed with conventional non-transplant treatments.
The aim of the study is to demonstrate unequivocally that liver transplantation may provide a survival benefit, with an acceptable survival rate of at least 60% at 5 years, to patients that demonstrate a radiological and sustained tumor response after downstaging. Noteworthy is that response is chosen rather than stage migration as endpoint of downstaging.
Read the detailed description
- Downstaging phase Patients that will be considered eligible for the study will undergo downstaging procedures according their stage of disease and to Center's policies. Length and intensity of downstaging will be center specific and not centrally pre-determined, but should be inferior to 18 months. Downstaging procedures will be stopped when, according to the Investigators' judgement, the best possible tumor response has been achieved: at this timepoint a radiological evaluation of tumor response according to modified RECIST (mRECIST) criteria will be performed. Patients that have achieved a Complete or Partial Response (PR or CR) will proceed to Bridging Phase, while those with a Stable or Progressive disease (SD or PD) will drop-out from the study.
- Bridging phase Patients that achieved PR or CR after downstaging will receive systemic therapy with sorafenib for three months. After three months radiological response will be assessed according to mRECIST criteria. If a sustained response will be demonstrated patients will proceed to randomization. PD during bridging phase will cause drop-out from the study.
- Randomization and study period
Patients will be randomized in a 1:1 ratio, using computer generated list stratified by Center and by compliance to sorafenib treatment (based on whether ≤50% or > 50% of the standard dosage (800 mg/day) has been administered).
- The experimental group (Group 1 - transplant strategy) will be enlisted for transplantation and will undergo liver transplantation within 8 months unless major medical or oncological contraindications should occur.
- The control group (Group 2 - non-transplant strategy) will continue with sorafenib until progression. Then they may be treated with either medical or locoregional/surgical therapies according to best practice and Centers' policy, excluding transplantation.
- Conditions
- Carcinoma, Hepatocellular, Cirrhosis
- Being tested
- Liver transplantation
- Keywords
- Hepatocellular Carcinoma, Liver Transplantation, Downstaging, Trans-arterial chemoembolization (TACE), Radiofrequency ablation (RFA), Liver resection, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Once randomized to Group 1, patients will be enlisted for liver transplantation at the recruiting Center. Prioritization is encouraged as a waiting time of more than 8 months could cause patients' drop-out from the study
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Transplant strategy | Experimental | Patients randomized to Group 1 will be enlisted for liver transplantation and will undergo liver transplantation within 8 months unless oncological (i.e. extrahepatic disease) or medical (i.e. cardiac insufficiency) will occur Receives: Procedure: Liver transplantation |
| Group 2 - Non-transplant strategy | No intervention | Patients randomized to Group 2 will continue to receive treatments according to their stage of disease, or will undergo only strict follow-up should a complete response after downstaging treatments have been achieved |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Phase II - Time to Tumoral Event (TTE)
TTE after randomization will be calculated as the interval between the randomization date and the date of tumour recurrence for tumor-free patients (either because of liver transplantation or complete response after downstaging procedures) or the date of tumour progression otherwise, with censoring at the date of last contact for event-free patients.
Measured: Every 4 months
For Phase III - Overall Survival
Time form the date of randomization and the date of death, with censoring at the date of last contact for event-free patients
Measured: Every 4 months
Secondary outcomes (3)
Transplant vs. non transplant strategy cost-benefit analysis
Comparison between the cost/benefit of a downstaging strategy followed by liver transplantation (treatment group) Vs the cost/benefit of convenional therapies (control group), analyzed according to the Quality Adjusted Life Years (QALY) gained in the treatment group
Measured: Approx. 1 year after the last patient randomized
Validation of modified RECIST criteria of radiological response to downstaging treatments
Radiology/pathology correlation on efficacy of downstaging treatments in achieving tumor response, as a basis for possible validation of modified RECIST criteria.
Measured: Approx. 8 months after the last patient randomized
Validation of the Metroticket model for the prognosis of survival after liver transplantation in patients exceeding Milan Criteria
http://www.hcc-olt-metroticket.org/
Measured: Approx. 1 year after the last patient randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJan 2011
- Primary completion31 Mar 2015
- Study completion31 Jul 2019
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 Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AISF (Associazione Italiana per lo Studio del Fegato), CNT (Centro Nazionale Trapianti), NITp (Nord Italia Transplant project), OCST (Organizzazione Centro Sud Trapianti), Associazione Italiana per la Ricerca sul Cancro, Ministero della Salute, Italy, Basilicata Region
- Responsible party
- Principal investigator, Vincenzo Mazzaferro, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Vincenzo Mazzaferro, MD, Principal investigator, Istituto Nazionale Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387503
- Sponsor's protocol ID
- INT 80/09
- Status last verified
- Oct 2021
- First submitted
- 30 Jun 2011
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Mazzaferro V, Llovet JM, Miceli R, Bhoori S, Schiavo M, Mariani L, Camerini T, Roayaie S, Schwartz ME, Grazi GL, Adam R, Neuhaus P, Salizzoni M, Bruix J, Forner A, De Carlis L, Cillo U, Burroughs AK, Troisi R, Rossi M, Gerunda GE, Lerut J, Belghiti J, Boin I, Gugenheim J, Rochling F, Van Hoek B, Majno P; Metroticket Investigator Study Group. Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis. Lancet Oncol. 2009 Jan;10(1):35-43. doi: 10.1016/S1470-2045(08)70284-5. Epub 2008 Dec 4.
PubMed 19058754Mazzaferro V, Regalia E, Doci R, Andreola S, Pulvirenti A, Bozzetti F, Montalto F, Ammatuna M, Morabito A, Gennari L. Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis. N Engl J Med. 1996 Mar 14;334(11):693-9. doi: 10.1056/NEJM199603143341104.
PubMed 8594428Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.
PubMed 18477802Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
PubMed 20175033Mazzaferro V, Citterio D, Bhoori S, Bongini M, Miceli R, De Carlis L, Colledan M, Salizzoni M, Romagnoli R, Antonelli B, Vivarelli M, Tisone G, Rossi M, Gruttadauria S, Di Sandro S, De Carlis R, Luca MG, De Giorgio M, Mirabella S, Belli L, Fagiuoli S, Martini S, Iavarone M, Svegliati Baroni G, Angelico M, Ginanni Corradini S, Volpes R, Mariani L, Regalia E, Flores M, Droz Dit Busset M, Sposito C. Liver transplantation in hepatocellular carcinoma after tumour downstaging (XXL): a randomised, controlled, phase 2b/3 trial. Lancet Oncol. 2020 Jul;21(7):947-956. doi: 10.1016/S1470-2045(20)30224-2.
PubMed 32615109
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Expansion of Conventional Criteria for Liver Transplantation in Hepatocellular Carcinoma Through Downstaging Procedures: a Randomized Trial (XXL Trial)
- ClinicalTrials.gov ID
- NCT01387503
- Acronym / sponsor ID
- INT 80/09
- Conditions
- Carcinoma, Hepatocellular, Cirrhosis
- Keywords
- Hepatocellular Carcinoma, Liver Transplantation, Downstaging, Trans-arterial chemoembolization (TACE), Radiofrequency ablation (RFA), Liver resection, Sorafenib
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- AISF (Associazione Italiana per lo Studio del Fegato), CNT (Centro Nazionale Trapianti), NITp (Nord Italia Transplant project), OCST (Organizzazione Centro Sud Trapianti), Associazione Italiana per la Ricerca sul Cancro, Ministero della Salute, Italy, Basilicata Region
- Study start
- Jan 2011
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 4 Jul 2011 (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.
This clinical trial is aimed at extending the chance of liver transplantation, through downstaging procedures, to patients with hepatocellular carcinoma (HCC) exceeding conventional Milan Criteria.
Those patients that will achieve a sustained tumor response after downstaging will be randomized either to undergo liver transplantation or to proceed with conventional non-transplant treatments.
The aim of the study is to demonstrate unequivocally that liver transplantation may provide a survival benefit, with an acceptable survival rate of at least 60% at 5 years, to patients that demonstrate a radiological and sustained tumor response after downstaging. Noteworthy is that response is chosen rather than stage migration as endpoint of downstaging.
Detailed description
- Downstaging phase Patients that will be considered eligible for the study will undergo downstaging procedures according their stage of disease and to Center's policies. Length and intensity of downstaging will be center specific and not centrally pre-determined, but should be inferior to 18 months. Downstaging procedures will be stopped when, according to the Investigators' judgement, the best possible tumor response has been achieved: at this timepoint a radiological evaluation of tumor response according to modified RECIST (mRECIST) criteria will be performed. Patients that have achieved a Complete or Partial Response (PR or CR) will proceed to Bridging Phase, while those with a Stable or Progressive disease (SD or PD) will drop-out from the study.
- Bridging phase Patients that achieved PR or CR after downstaging will receive systemic therapy with sorafenib for three months. After three months radiological response will be assessed according to mRECIST criteria. If a sustained response will be demonstrated patients will proceed to randomization. PD during bridging phase will cause drop-out from the study.
- Randomization and study period
Patients will be randomized in a 1:1 ratio, using computer generated list stratified by Center and by compliance to sorafenib treatment (based on whether ≤50% or > 50% of the standard dosage (800 mg/day) has been administered).
- The experimental group (Group 1 - transplant strategy) will be enlisted for transplantation and will undergo liver transplantation within 8 months unless major medical or oncological contraindications should occur.
- The control group (Group 2 - non-transplant strategy) will continue with sorafenib until progression. Then they may be treated with either medical or locoregional/surgical therapies according to best practice and Centers' policy, excluding transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Transplant strategy | Experimental | Procedure: Liver transplantationPatients randomized to Group 1 will be enlisted for liver transplantation and will undergo liver transplantation within 8 months unless oncological (i.e. extrahepatic disease) or medical (i.e. cardiac insufficiency) will occur |
| Group 2 - Non-transplant strategy | No intervention | –Patients randomized to Group 2 will continue to receive treatments according to their stage of disease, or will undergo only strict follow-up should a complete response after downstaging treatments have been achieved |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient's age ≥ 18 yrs and ≤ 65 yrs
- Presence of cirrhosis of any etiology
- Child-Pugh class ≤ B7
- ECOG Performance Status ≤ 1
- Diagnosis of HCC either by biopsy or according to AASLD criteria
Key exclusion criteria (10 listed)
- Presence of extra-hepatic tumor spread
- Presence of macrovascular invasion
- Sorafenib therapy started > 2 months before enrolment
- Concurrent cancer, distinct from HCC (except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors)
- Previous history of any cancer, even if curatively treated, < 5 years prior to entry
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 |
|---|---|---|
| Liver transplantationOnce randomized to Group 1, patients will be enlisted for liver transplantation at the recruiting Center. Prioritization is encouraged as a waiting time of more than 8 months could cause patients' drop-out from the study | Procedure or surgery | Group 1 - Transplant strategy |
Primary outcome
For Phase II - Time to Tumoral Event (TTE)
Time frame: Every 4 months
TTE after randomization will be calculated as the interval between the randomization date and the date of tumour recurrence for tumor-free patients (either because of liver transplantation or complete response after downstaging procedures) or the date of tumour progression otherwise, with censoring at the date of last contact for event-free patients.
For Phase III - Overall Survival
Time frame: Every 4 months
Time form the date of randomization and the date of death, with censoring at the date of last contact for event-free patients
3 secondary outcomes
Transplant vs. non transplant strategy cost-benefit analysis
Time frame: Approx. 1 year after the last patient randomized
Validation of modified RECIST criteria of radiological response to downstaging treatments
Time frame: Approx. 8 months after the last patient randomized
Validation of the Metroticket model for the prognosis of survival after liver transplantation in patients exceeding Milan Criteria
Time frame: Approx. 1 year after the last patient randomized
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 11 Oct 2021.
- Background: PubMed 19058754Mazzaferro V, Llovet JM, Miceli R, Bhoori S, Schiavo M, Mariani L, Camerini T, Roayaie S, Schwartz ME, Grazi GL, Adam R, Neuhaus P, Salizzoni M, Bruix J, Forner A, De Carlis L, Cillo U, Burroughs AK, Troisi R, Rossi M, Gerunda GE, Lerut J, Belghiti J, Boin I, Gugenheim J, Rochling F, Van Hoek B, Majno P; Metroticket Investigator Study Group. Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis. Lancet Oncol. 2009 Jan;10(1):35-43. doi: 10.1016/S1470-2045(08)70284-5. Epub 2008 Dec 4.
- Background: PubMed 8594428Mazzaferro V, Regalia E, Doci R, Andreola S, Pulvirenti A, Bozzetti F, Montalto F, Ammatuna M, Morabito A, Gennari L. Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis. N Engl J Med. 1996 Mar 14;334(11):693-9. doi: 10.1056/NEJM199603143341104.
- Background: PubMed 18477802Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.
- Background: PubMed 20175033Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
- Derived from this study: PubMed 32615109Mazzaferro V, Citterio D, Bhoori S, Bongini M, Miceli R, De Carlis L, Colledan M, Salizzoni M, Romagnoli R, Antonelli B, Vivarelli M, Tisone G, Rossi M, Gruttadauria S, Di Sandro S, De Carlis R, Luca MG, De Giorgio M, Mirabella S, Belli L, Fagiuoli S, Martini S, Iavarone M, Svegliati Baroni G, Angelico M, Ginanni Corradini S, Volpes R, Mariani L, Regalia E, Flores M, Droz Dit Busset M, Sposito C. Liver transplantation in hepatocellular carcinoma after tumour downstaging (XXL): a randomised, controlled, phase 2b/3 trial. Lancet Oncol. 2020 Jul;21(7):947-956. doi: 10.1016/S1470-2045(20)30224-2.
- The system will calculate the 3 and 5 year predicted survival of a given patient with HCC undergoing liver transplantationLink 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.
Vincenzo Mazzaferro, MD principal investigator
Istituto Nazionale Tumori, Milano
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver transplantation in people with Carcinoma, Hepatocellular and Cirrhosis, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 10 sites in Italy.
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 8 inclusion and 10 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. 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.
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?
For Phase II - Time to Tumoral Event (TTE) (time frame: Every 4 months). The study lists 2 primary outcomes in all. 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 NCT01387503, 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 11 Oct 2021.