HepatocarcinomaNCT06886763
HCC Innervation Assessment
An observational study of Hepatocarcinoma, run by Hospices Civils de Lyon at 2 sites in 2 countries.
Trial summary
Primary liver cancer casualties are ranked 3rd worldwide and are still on the rise despite the recent advent of adequate hepatitis B and C therapies. Genetic diseases of the liver and hepatic comorbidities, such as alcoholic liver disease and metabolic syndrome with metabolic-associated steatohepatitis, are long-term… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatocarcinoma
- What is being tested?
- Liver innervation markers
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jun 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 patients with hepatocarcinoma who undergo surgical resection or liver transplant will be recruited at Hospitals of Lyon (GHN, GHS)
Who may be able to join
- Patients with hepatocarcinoma who undergo surgical resection or liver transplant
- Patients with and without treatment
Who cannot join
- - Pregnant or lactating women
- Minor patient
- Patient under legal protection measure or deprived of their liberty
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Groupement Hospitalier Nord, Hospices Civils de Lyon
France, 69004
About this study
Official title: Assessment of Hepatocarcinoma Innervation by Tissue Transparisation and Pharmacological Screening
Primary liver cancer casualties are ranked 3rd worldwide and are still on the rise despite the recent advent of adequate hepatitis B and C therapies. Genetic diseases of the liver and hepatic comorbidities, such as alcoholic liver disease and metabolic syndrome with metabolic-associated steatohepatitis, are long-term cooperators or independent factors fostering the onset of hepatocellular carcinoma (HCC) and enhancing disease heterogeneity. Though HCC is known to develop in 90% of cases of cirrhosis, its onset and clinical outcomes, in terms of phenotypes and speed of progression, are highly variable from one patient to another. Despite the identification of several potential therapeutic targets, most drugs have failed to exceed the efficacy of currently available compounds. Treatments with tyrosine kinase inhibitors for instance lead to short-term, unavoidable relapse, whereas treatment with immune checkpoints inhibitors or growth factors inhibitors currently provide some hope for only a minority of patients with unresectable HCC.
In this respect, cellular/tissular structures linking the general pathophysiology of the patient with HCC may be of interest, as they are patient-specific and may uncover novel ways of defining stratification criteria. In line with such notions, several recent original papers and related commentaries highlighted the relevance of studying cancer neurosciences of peripheral organs. In that context, pathological innervation and autonomous nervous system involvement or dysregulation have been identified in ovarian, prostate, gastric and pancreatic cancers, nurturing tumor stroma and conferring stronger carcinogenic properties. Moreover, the autonomic nervous system post-synaptic receptors have been shown to be favorably actionable in some experimental conditions in cancer.
Read more
The autonomic nervous system comprises the sympathetic (adrenergic signaling) and parasympathetic (cholinergic signaling) arms that relay signals both ways along the brain-liver neural axis in order to regulate involuntary functions of the body by adjusting its internal functions, after an external stimulus. The liver is an innervated organ that hosts autonomic afferent and efferent autonomic nervous system nerves, in constant communication with the central nervous system through the brainstem. Afferent and efferent nerves are made of adrenergic (relies on epinephrine or norepinephrine as its neurotransmitter, stress signal) and cholinergic (relies on acetylcholine as its neurotransmitter, resting signal) fibers that each convey mediators to regulate liver functions in real-time.
As a consequence, as also notably pointed out by Tracey's theory and evidence for cholinergic blockade of inflammation, these signals also regulate several processes that may directly or indirectly impact HCC onset and growth. However, data on the association between HCC and neural factors are scarce and sometimes conflicting. It was reported that portal hypertension, a recognized risk factor for HCC development and recurrence, is correlated with autonomic nervous system dysfunction. In addition, proliferation of hepatocytic progenitors, instrumental in HCC, is impaired by adrenergic signaling. Conversely, cholinergic signaling was shown to attenuate apoptosis in the mouse liver, and liver angiogenesis is under positive sympathetic regulation. Interestingly, human liver autonomic nervous system innervation is more developed than in rodents. Indeed, it extends deeper into the lobule, increasing its capacities of regulation. This latter notion suggests that autonomic nervous system-related mechanisms observed in animals may play more important roles in humans.
The primary goal of this study is to assess the innervation of tumor and peritumor tissues in HCC patients who undergo liver resection or liver transplant.
- Conditions
- Hepatocarcinoma
- Being tested
- Liver innervation markers
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver innervation markersOther
Liver innervation markers will be quantified immediately after resection by transparisation technique.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HCC candidates for hepatectomy or liver transplantation, with and without treatment | Not described Receives: Other: Liver innervation markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of morphological parameters (mature, immature, sympathetic and parasympathetic nerves) of innervation of peritumoral and tumor tissue using tissue transparisation (clearing) techniques.
Measured: Outcome measure will be assessed immediately after the surgery on fresh tissues. No follow-up is required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start30 Jun 2024
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886763
- Sponsor's protocol ID
- 69HCL24_1190
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hepatocarcinoma Innervation by Tissue Transparisation and Pharmacological Screening
- ClinicalTrials.gov ID
- NCT06886763
- Acronym / sponsor ID
- 69HCL24_1190
- Conditions
- Hepatocarcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Mar 2025 (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.
Primary liver cancer casualties are ranked 3rd worldwide and are still on the rise despite the recent advent of adequate hepatitis B and C therapies. Genetic diseases of the liver and hepatic comorbidities, such as alcoholic liver disease and metabolic syndrome with metabolic-associated steatohepatitis, are long-term cooperators or independent factors fostering the onset of hepatocellular carcinoma (HCC) and enhancing disease heterogeneity. Though HCC is known to develop in 90% of cases of cirrhosis, its onset and clinical outcomes, in terms of phenotypes and speed of progression, are highly variable from one patient to another. Despite the identification of several potential therapeutic targets, most drugs have failed to exceed the efficacy of currently available compounds. Treatments with tyrosine kinase inhibitors for instance lead to short-term, unavoidable relapse, whereas treatment with immune checkpoints inhibitors or growth factors inhibitors currently provide some hope for only a minority of patients with unresectable HCC.
In this respect, cellular/tissular structures linking the general pathophysiology of the patient with HCC may be of interest, as they are patient-specific and may uncover novel ways of defining stratification criteria. In line with such notions, several recent original papers and related commentaries highlighted the relevance of studying cancer neurosciences of peripheral organs. In that context, pathological innervation and autonomous nervous system involvement or dysregulation have been identified in ovarian, prostate, gastric and pancreatic cancers, nurturing tumor stroma and conferring stronger carcinogenic properties. Moreover, the autonomic nervous system post-synaptic receptors have been shown to be favorably actionable in some experimental conditions in cancer.
The autonomic nervous system comprises the sympathetic (adrenergic signaling) and parasympathetic (cholinergic signaling) arms that relay signals both ways along the brain-liver neural axis in order to regulate involuntary functions of the body by adjusting its internal functions, after an external stimulus. The liver is an innervated organ that hosts autonomic afferent and efferent autonomic nervous system nerves, in constant communication with the central nervous system through the brainstem. Afferent and efferent nerves are made of adrenergic (relies on epinephrine or norepinephrine as its neurotransmitter, stress signal) and cholinergic (relies on acetylcholine as its neurotransmitter, resting signal) fibers that each convey mediators to regulate liver functions in real-time.
As a consequence, as also notably pointed out by Tracey's theory and evidence for cholinergic blockade of inflammation, these signals also regulate several processes that may directly or indirectly impact HCC onset and growth. However, data on the association between HCC and neural factors are scarce and sometimes conflicting. It was reported that portal hypertension, a recognized risk factor for HCC development and recurrence, is correlated with autonomic nervous system dysfunction. In addition, proliferation of hepatocytic progenitors, instrumental in HCC, is impaired by adrenergic signaling. Conversely, cholinergic signaling was shown to attenuate apoptosis in the mouse liver, and liver angiogenesis is under positive sympathetic regulation. Interestingly, human liver autonomic nervous system innervation is more developed than in rodents. Indeed, it extends deeper into the lobule, increasing its capacities of regulation. This latter notion suggests that autonomic nervous system-related mechanisms observed in animals may play more important roles in humans.
The primary goal of this study is to assess the innervation of tumor and peritumor tissues in HCC patients who undergo liver resection or liver transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HCC candidates for hepatectomy or liver transplantation, with and without treatment | – | Other: Liver innervation markers |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 patients with hepatocarcinoma who undergo surgical resection or liver transplant will be recruited at Hospitals of Lyon (GHN, GHS)
Key inclusion criteria (2 listed)
- Patients with hepatocarcinoma who undergo surgical resection or liver transplant
- Patients with and without treatment
Key exclusion criteria (3 listed)
- - Pregnant or lactating women
- Minor patient
- Patient under legal protection measure or deprived of their liberty
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 innervation markersLiver innervation markers will be quantified immediately after resection by transparisation technique. | Other | Patients with HCC candidates for hepatectomy or liver transplantation, with and without treatment |
Primary outcome
Assessment of morphological parameters (mature, immature, sympathetic and parasympathetic nerves) of innervation of peritumoral and tumor tissue using tissue transparisation (clearing) techniques.
Time frame: Outcome measure will be assessed immediately after the surgery on fresh tissues. No follow-up is required.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocarcinoma, run by Hospices Civils de Lyon at 2 sites in 2 countries.
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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, 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?
This study is still under way. Results are not available in the source record yet.
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?
Assessment of morphological parameters (mature, immature, sympathetic and parasympathetic nerves) of innervation of peritumoral and tumor tissue using tissue transparisation (clearing) techniques. (time frame: Outcome measure will be assessed immediately after the surgery on fresh tissues. No follow-up is required.). 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 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.