Cirrhosis With Hepatocellular CarcinomaECHEFNCT07189624
Effect of Acute Endurance Exercise on the Production of FGF21 and Follistatin in Patients With Hepatocellular Carcinoma
A study testing Exercise in people with Cirrhosis With Hepatocellular Carcinoma, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
The main purpose of the study is to characterize the production of hepatokines (FGF21 and Follistatin) in response to a submaximal exercise on an ergocycle, in patients with hepatocellular carcinoma. The effect of exercise on hepatokines and metabolites production in liver cancer patients is not known. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis With Hepatocellular Carcinoma
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2025to Apr 2029
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma developed on cirrhosis
- Cirrhosis of any etiology, defined by a liver elasticity measurement >15kPa or a history of cirrhosis decompensation
- Hepatocellular carcinoma with indication for treatment by immunotherapy or chemoembolization
- Child-Pugh scores A and B7
- WHO score ≤ 2
- Affiliation to french national social security system
Who cannot join
- Hepatic encephalopathy grade II or higher
- Bone metastasis
- Surgery performed within 30 days prior to inclusion visit
- Liver transplant
- Muscle injury within 3 months of inclusion
- Pregnant or breast-feeding women
- Patients under legal protection (guardianship, curatorship, safeguard of justice)
- Participation in another clinical trial within 10 days of inclusion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Chu Estaing Medecine Digestive Et Hepatobiliaire
Clermont-Ferrand, 63003
ARMANDO ABERGEL, +334 73 75 05 23, aabergel@chu-clermontferrand.fr
CHU de Clermont-Ferrand
Clermont-Ferrand
lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr
Armando ABERGEL
About this study
The main purpose of the study is to characterize the production of hepatokines (FGF21 and Follistatin) in response to a submaximal exercise on an ergocycle, in patients with hepatocellular carcinoma. The effect of exercise on hepatokines and metabolites production in liver cancer patients is not known. Studying this production could help to provide relevant recommendations for training programming in these patients.
- Conditions
- Cirrhosis With Hepatocellular Carcinoma
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
30-minutes exercise on a bicycle with heart rate monitor and gas exchange analyzer.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | A single study visit will be required, during which the following will be caried out:
* an assessment of physical condition: lower limb isometric strength test, liver frailty index, short physical performance battery, ultrasound assessment of quadriceps muscle mass
* a 30-minutes exercise session on a bicycle (with heart rate monitor and gas exchange analyzer)
* 3 fasting blood tests (before, at the end and 1 hour after the exercise) to assess the production of hepatokines and metabolites
* measurements of perceived fatigue, muscle pain and effort (before, at the end and 1 hour after the exercise).
Snacks will be served afterwards. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic hepatokines rates (FGF-21 and follistatin)
Blood samples
Measured: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise
Secondary outcomes (1)
Muscle pain assessment
Visual analog scale. Score from 0 (total absence of muscle pain) to 10 (maximum muscle pain).
Measured: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study startDec 2025 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis With Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189624
- Sponsor's protocol ID
- RBHP 2024 ABERGEL
- Acronym
- ECHEF
- Status last verified
- Dec 2025
- First submitted
- 16 May 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Endurance Exercise on the Production of FGF21 and Follistatin in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07189624
- Acronym / sponsor ID
- ECHEF / RBHP 2024 ABERGEL
- Conditions
- Cirrhosis With Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 24 Sep 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.
The main purpose of the study is to characterize the production of hepatokines (FGF21 and Follistatin) in response to a submaximal exercise on an ergocycle, in patients with hepatocellular carcinoma. The effect of exercise on hepatokines and metabolites production in liver cancer patients is not known. Studying this production could help to provide relevant recommendations for training programming in these patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: ExerciseA single study visit will be required, during which the following will be caried out: * an assessment of physical condition: lower limb isometric strength test, liver frailty index, short physical performance battery, ultrasound assessment of quadriceps muscle mass * a 30-minutes exercise session on a bicycle (with heart rate monitor and gas exchange analyzer) * 3 fasting blood tests (before, at the end and 1 hour after the exercise) to assess the production of hepatokines and metabolites * measurements of perceived fatigue, muscle pain and effort (before, at the end and 1 hour after the exercise). Snacks will be served afterwards. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hepatocellular carcinoma developed on cirrhosis
- Cirrhosis of any etiology, defined by a liver elasticity measurement >15kPa or a history of cirrhosis decompensation
- Hepatocellular carcinoma with indication for treatment by immunotherapy or chemoembolization
- Child-Pugh scores A and B7
- WHO score ≤ 2
Key exclusion criteria (8 listed)
- Hepatic encephalopathy grade II or higher
- Bone metastasis
- Surgery performed within 30 days prior to inclusion visit
- Liver transplant
- Muscle injury within 3 months of inclusion
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 |
|---|---|---|
| Exercise30-minutes exercise on a bicycle with heart rate monitor and gas exchange analyzer. | Other | Single arm |
Primary outcome
Systemic hepatokines rates (FGF-21 and follistatin)
Time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise
Blood samples
1 secondary outcome
Muscle pain assessment
Time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise
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 31 Dec 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cirrhosis With Hepatocellular Carcinoma, run by University Hospital, Clermont-Ferrand at 2 sites 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 6 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: opening soon, as of the sponsor's last update on 31 Dec 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 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?
Contact Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic hepatokines rates (FGF-21 and follistatin) (time frame: Baseline (pre-exercise), immediately after exercise, 1 hour after the end of exercise). 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 31 Dec 2025.