Hepatocellular CarcinomaHCC-CTPerfNCT03140332
Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib.
A study testing Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib in people with Hepatocellular Carcinoma and Perfusion Scanner, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Perfusion Scanner
- What is being tested?
- Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2017to 27 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged over 18 years
- Affiliation to a social security scheme
- CHC developed irrespective of the level of fibrosis of the non-tumorous liver, and whatever the etiology
- Advanced hepatocellular carcinoma confirmed histologically or having the typical characteristics in imaging after validation in CPR (abdomino-pelvic CT scan with triphasic injection or hepatic MRI with gadolinium injection): hypervascularized nodule at the early arterial time (wash in) with washing ("Wash out") in relation to the non-tumoral parenchyma
- Hepatocellular carcinoma:
- With a naive measurable target lesion of any treatment
Show all 16Show fewer
- Who can not benefit from curative treatment (non-operable, non-transplantable, non-radio-frequenable) and who have never benefited from systemic chemotherapy treatment
- Or with appearance after chemo-embolization of target lesions according to the mRECIST criteria in the contralateral liver
- in the case of right or left arteriovenous fistula, the target lesion will be chosen in the contralateral liver
- Indication of treatment by sorafenib after validation in a multidisciplinary consultation meeting:
- Stadium BCLC C
- Cirrhosis classified Child-Pugh A or B7
- Performance status less than or equal to 2
- Preserved haematological function (platelet count ≥ 60000 / mm3, hemoglobin ≥ 8.5 g / dL)
- Hepatic function (albumin ≥ 28 g / L, total bilirubin ≤ 50 μmol / L, ALAT and ASAT ≤ 5 N, INR ≤ 2.3 or TP> 40%)
- Renal function conserved (creatinine ≤ 1.5 times the upper limit of normal)
Who cannot join
- Other evolutionary cancer requiring treatment
- History of treatment with sorafenib or anti-angiogenic therapy
- History of treatment by chemoembolization without appearance of target lesion in the contralateral liver
- Diffuse CHC with no measurable lesion
- Patient with TIPS, portal cavernoma, extensive portal thrombosis, or arterio-portal fistula in the same area of assessment of the CHC nodule
- Allergic reaction or hypersensitivity to a contrast agent
- Pregnancy
- Patient under tutorship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response should be performed with mRECIST criteria that are significantly better correlated with survival. These criteria take into account the tumor size and also the modification of the tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate tumor control rather than tumor response since sorafenib is more stable than tumor response.
This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months. The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected patients, and with undesirable effects and a significant cost. Predictive biological criteria have already been studied, such as alpha foeto-protein (AFP), whose early decrease with sorafenib is associated with better overall survival. The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 1.1 criteria. The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs. On the other hand, an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival.
Therefore, the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC.
- Conditions
- Hepatocellular Carcinoma, Perfusion Scanner
- Being tested
- Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenibOther
To evaluate the association between tumor perfusion criteria (blood flow, blood volume, mean transit time, capillary permeability) at the initial perfusion scan and tumor control according to the mRECIST criteria after 3 months of treatment with sorafenib.
| Study group | Role | What they receive |
|---|---|---|
| Patient with CHC | Other | Not described Receives: Other: Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scannographic evaluation of tumor response with mRECIST criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start27 Feb 2017
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140332
- Sponsor's protocol ID
- PI2016_843_0025
- Acronym
- HCC-CTPerf
- Status last verified
- Jul 2020
- First submitted
- 27 Apr 2017
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib.
- ClinicalTrials.gov ID
- NCT03140332
- Acronym / sponsor ID
- HCC-CTPerf / PI2016_843_0025
- Conditions
- Hepatocellular Carcinoma, Perfusion Scanner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 4 May 2017 (actual)
- 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.
Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response should be performed with mRECIST criteria that are significantly better correlated with survival. These criteria take into account the tumor size and also the modification of the tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate tumor control rather than tumor response since sorafenib is more stable than tumor response.
This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months. The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected patients, and with undesirable effects and a significant cost. Predictive biological criteria have already been studied, such as alpha foeto-protein (AFP), whose early decrease with sorafenib is associated with better overall survival. The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 1.1 criteria. The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs. On the other hand, an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival.
Therefore, the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with CHC | Other | Other: Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient aged over 18 years
- Affiliation to a social security scheme
- CHC developed irrespective of the level of fibrosis of the non-tumorous liver, and whatever the etiology
- Advanced hepatocellular carcinoma confirmed histologically or having the typical characteristics in imaging after validation in CPR (abdomino-pelvic CT scan with triphasic injection or hepatic MRI with gadolinium injection): hypervascularized nodule at the early arterial time (wash in) with washing ("Wash out") in relation to the non-tumoral parenchyma
- Hepatocellular carcinoma:
Key exclusion criteria (8 listed)
- Other evolutionary cancer requiring treatment
- History of treatment with sorafenib or anti-angiogenic therapy
- History of treatment by chemoembolization without appearance of target lesion in the contralateral liver
- Diffuse CHC with no measurable lesion
- Patient with TIPS, portal cavernoma, extensive portal thrombosis, or arterio-portal fistula in the same area of assessment of the CHC nodule
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 |
|---|---|---|
| Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenibTo evaluate the association between tumor perfusion criteria (blood flow, blood volume, mean transit time, capillary permeability) at the initial perfusion scan and tumor control according to the mRECIST criteria after 3 months of treatment with sorafenib. | Other | Patient with CHC |
Primary outcome
Scannographic evaluation of tumor response with mRECIST criteria
Time frame: 1 year
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 20 Jul 2020.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib in people with Hepatocellular Carcinoma and Perfusion Scanner, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 16 inclusion and 8 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 20 Jul 2020. 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 France. 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?
Scannographic evaluation of tumor response with mRECIST criteria (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2020.