Liver InjuryCO-CHILINCT06864481
Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis
An observational study of Liver Injury and Secondary to Immune Checkpoint Inhibitors, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background and Study Rationale Immune checkpoint inhibitors (ICI) are a breakthrough cancer treatment that boosts the immune system to fight tumors. While effective, they can cause immune-related side effects, including liver inflammation (ICI-induced hepatitis or CHILI), which affects up to 25% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Injury, Secondary to Immune Checkpoint Inhibitors, Cancer Patients
- What is being tested?
- Blood samples
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2025to 22 Apr 2028
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients will be included at the hospital
Who may be able to join
- Age ≥ 18 years
- Patient willing to participate in the study
- Patient with cancer receiving neoadjuvant, adjuvant, or maintenance treatment · Patient treated with ICI, either as monotherapy or in combination with another antitumor treatment (targeted therapy, chemotherapy, or radiotherapy), either de novo or after a first-line treatment including ICIs
- Patient who has received at least one injection of an ICI ·
- Onset of hepatitis following treatment initiation, defined by the following criteria:
- ALT (alanine aminotransferase) ≥ 5 times the upper normal limit
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- ALP (alkaline phosphatase) ≥ 2 times the upper normal limit
- ALT (alanine aminotransferase) ≥ 3 times the upper normal limit and bilirubin ≥ 2 times the upper normal limit ·
- Patient with grade 3 or 4 hepatitis, according to the current CTCAE classification
Who cannot join
- Patient with another cause of acute hepatitis, including viral, autoimmune, ischemic, acute alcoholic hepatitis, or Wilson's disease.
- Patient unable to express their non-opposition to participate in the study.
- Person deprived of liberty, under guardianship or curatorship, or in an emergency situation.
- Person not affiliated with a social security system or without entitlement to healthcare coverage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, 34295
Lucy MEUNIER, MD, +33467330224 ext. +33, lucy-meunier@chu-montpellier.fr
About this study
Official title: Description, Course and Treatment of Immune Checkpoint Inhibitor-induced Hepatitis
Background and Study Rationale Immune checkpoint inhibitors (ICI) are a breakthrough cancer treatment that boosts the immune system to fight tumors. While effective, they can cause immune-related side effects, including liver inflammation (ICI-induced hepatitis or CHILI), which affects up to 25% of patients. Severe cases requiring treatment discontinuation are rare but challenging to manage.
Study Objective This multicenter prospective study aims to better understand CHILI, its clinical patterns, treatment response, and risk of recurrence. It will focus on different types of liver injury (cholestatic, hepatocellular, or mixed) to guide better treatment decisions.
Innovation and Approach Currently, there is no clear consensus on how to manage CHILI or when to safely restart immunotherapy. This study will collect real-world data from adult patients treated with ICIs, following international guidelines or a pragmatic approach when no consensus exists. Findings will help improve care strategies for patients experiencing ICI-related liver toxicity.
- Being tested
- Blood samples
- Keywords
- Immune checkpoint inhibitors, Immunotherapy, Drug-induced liver injury, Hepatitis, Cholangitis, Ursodeoxycholic acid
- Medical subject headings
- Chemical and Drug Induced Liver Injury, Hepatitis, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
one Blood sample (20 ml)
| Study group | Role | What they receive |
|---|---|---|
| Immune Checkpoint Inhibitor-Induced Hepatitis | Observational cohort Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype
Measured: Day0, Day14, Day30, Day 90, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start22 Apr 2025
- Primary completion22 Apr 2028 (estimated)
- Study completion22 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 250 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- French Association for the Study of the Liver
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864481
- Sponsor's protocol ID
- RECHMPL24_0283
- Acronym
- CO-CHILI
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2025
- Last updated
- 18 Jun 2026
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description, Course and Treatment of Immune Checkpoint Inhibitor-induced Hepatitis
- ClinicalTrials.gov ID
- NCT06864481
- Acronym / sponsor ID
- CO-CHILI / RECHMPL24_0283
- Keywords
- Immune checkpoint inhibitors, Immunotherapy, Drug-induced liver injury, Hepatitis, Cholangitis, Ursodeoxycholic acid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- French Association for the Study of the Liver
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 22 Apr 2028 (estimated)
- Study completion
- 22 Apr 2028 (estimated)
- First posted
- 7 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.
Background and Study Rationale Immune checkpoint inhibitors (ICI) are a breakthrough cancer treatment that boosts the immune system to fight tumors. While effective, they can cause immune-related side effects, including liver inflammation (ICI-induced hepatitis or CHILI), which affects up to 25% of patients. Severe cases requiring treatment discontinuation are rare but challenging to manage.
Study Objective This multicenter prospective study aims to better understand CHILI, its clinical patterns, treatment response, and risk of recurrence. It will focus on different types of liver injury (cholestatic, hepatocellular, or mixed) to guide better treatment decisions.
Innovation and Approach Currently, there is no clear consensus on how to manage CHILI or when to safely restart immunotherapy. This study will collect real-world data from adult patients treated with ICIs, following international guidelines or a pragmatic approach when no consensus exists. Findings will help improve care strategies for patients experiencing ICI-related liver toxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immune Checkpoint Inhibitor-Induced Hepatitis | – | Other: Blood samplesObservational cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients will be included at the hospital
Key inclusion criteria (9 listed)
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Patient with another cause of acute hepatitis, including viral, autoimmune, ischemic, acute alcoholic hepatitis, or Wilson's disease.
- Patient unable to express their non-opposition to participate in the study.
- Person deprived of liberty, under guardianship or curatorship, or in an emergency situation.
- Person not affiliated with a social security system or without entitlement to healthcare coverage.
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 |
|---|---|---|
| Blood samplesone Blood sample (20 ml) | Other | Immune Checkpoint Inhibitor-Induced Hepatitis |
Primary outcome
Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype
Time frame: Day0, Day14, Day30, Day 90, Month 6 and Month 12
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 18 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Injury and Secondary to Immune Checkpoint Inhibitors, run by University Hospital, Montpellier 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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?
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 Lucy MEUNIER, M.D (Phone: +33467330224, lucy-meunier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype (time frame: Day0, Day14, Day30, Day 90, Month 6 and Month 12). 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 18 Jun 2026.