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HepatocarcinomaNCT06886763

HCC Innervation Assessment

An observational study of Hepatocarcinoma, run by Hospices Civils de Lyon at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Egypt1 site
  • Groupement hospitalier Sud, Hospices Civils de Lyon

    France, 69230

Other trials in Egypt

France1 site
  • Groupement Hospitalier Nord, Hospices Civils de Lyon

    France, 69004

Other trials in France

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 groups in NCT06886763
Study groupRoleWhat they receive
Patients with HCC candidates for hepatectomy or liver transplantation, with and without treatmentNot described
Receives: Other: Liver innervation markers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted20 Mar 2025
  2. Study start30 Jun 2024
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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)
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

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.

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