Hepatocellular CarcinomaPhase 4CLERANCENCT03963206
Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)
A Phase 4 study testing Cabozantinib group in people with Hepatocellular Carcinoma, run by Hospices Civils de Lyon at 18 sites in France.
Trial summary
Hepatocellular carcinoma (HCC) is a common tumor (the 8th leading cause of cancer in France) and has a poor prognosis. It is the 3rd leading cause of cancer deaths in the world. In the early stages (low tumor mass), HCC can be treated for curative purposes by surgical resection, percutaneous ablation or liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Cabozantinib group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 18 sitesFrance
- Study dates
- 9 Sep 2019to 7 Oct 2021
- Phase
- Phase 4
- 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
- Major patient (age ≥ 18 years).
- Patient with a histologically proven HCC, or by radiology if cirrhotic liver (according to international recommendations).
- Patient with stage B BCLC classification after failure or impossibility of transarterial chemoembolization (TACE), or advanced stage C having already received one to two systemic lines, including one by Sorafenib.
- eastern cooperative oncology group score of 0 or 1 (ECOG).
- Child-Pugh A5 or A6 score.
- Disease evaluable by RECIST v1.1 and mRECIST.
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- Hemoglobin> 8.5g / dL.
- Platelets> 60 giga / L.
- neutrophils> 1.2 giga / L.
- ALAT and ASAT <5N
- Patient having a normal magnesium level
- Clearance with creatinine> 40ml / min (by the MDRD formula).
- For patients who have had radiotherapy on the liver: a wash out of at least one month before the start of the treatment under study must be respected.
- For patients who have had a radioembolization a wash out of at least three months before the beginning of the treatment under study must be respected.
- Patient who agreed to participate in the study and signed the informed consent.
- Patient affiliated to a social security scheme.
Who cannot join
- Patient with another cancer not cured or whose complete remission has been obtained for less than 2 years compared to the date of inclusion in CLERANCE.
- Patients eligible for surgical resection or radiofrequency ablation or liver transplantation or TACE according to international recommendations.
- Patient who has already had more than two lines of systemic treatment for his HCC (tyrosine kinase inhibitor, intravenous cytotoxic chemotherapy, immunotherapy, hormonal therapy for HCC).
- Patient who has never received Sorafenib in his previous systemic line (s).
- Patient who has already received a c-MET inhibitor.
- Patient with chronic viral B infection known not treated with a nucleoside / nucleotide analogue.
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- Patients infected with HIV known (even if it is viro-suppressed by anti-retroviral treatments).
- Patients with or at risk for severe bleeding (a gastroscopy should be performed every two years if the patient doesn't have varicose veins and every year if the patient has varicose vein).
- Patients with inflammatory bowel diseases (Crohn's disease, ulcerative colitis, peritonitis, diverticulitis, appendicitis)
- Patient with galactose intolerance or Lapp lactase deficiency, or glucose or galactose malabsorption syndrome.
- Patients with tumor infiltration of the digestive tract with risk of fistulation
- Patients with recent digestive surgery (<1 month) or not yet fully healed.
- Patients with QTcF> 480 ms on inclusion ECG.
- Known hypersensitivity to Cabozantinib or to any of the excipients.
- Pregnant or nursing woman.
- Patient of childbearing age without mechanical contraception.
- Patient placed under safeguard of justice (tutelage or curatorship).
- Patient not benefiting from social security.
- Patient participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (except interventional research with minimal risks and constraints that do not interfere with the judgment criteria of the study according to the judgment of the coordinating investigator).
- Chronic active C infection is not a contraindication. Treatment with direct antiviral agents is left to the discretion of each investigator, but the viremic or cured status of each patient should be mentioned.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU Amiens Picardie - Hôpital Sud
Amiens
CHU Jean Minjoz
Besançon
Hôpital Avicenne
Bobigny
Centre Hospitalier de Boulogne sur mer
Boulogne-sur-Mer
Centre hospitalier universitaire Côte de nacre
Caen
Hôpital Beaujon
Clichy
CHRU de Lille-Hôpital Claude Huriez
Lille
CHU Dupuytren
Limoges
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, 69004
APHM - Timone
Marseille
Centre Hospitalier Universitaire de Montpellier
Montpellier
APHP - Hôpital St Antoine
Paris
Hôpital haut- lévêque
Pessac
Hôpital Robert Debré - CHU de Reims
Reims
CHRU Rennes site pontchaillou
Rennes
CHU de St Etienne
Saint-Priest-en-Jarez
CHU Toulouse PURPAN
Toulouse
Hôpital Brabois adulte - CHU de Nancy
Vandœuvre-lès-Nancy
About this study
Official title: CLERANCE HCC, Cabozantinib toLERANCE Study in HepatoCellular Carcinoma
Hepatocellular carcinoma (HCC) is a common tumor (the 8th leading cause of cancer in France) and has a poor prognosis. It is the 3rd leading cause of cancer deaths in the world. In the early stages (low tumor mass), HCC can be treated for curative purposes by surgical resection, percutaneous ablation or liver transplantation. When the tumor mass is larger (> 3 nodules) but remains confined to the liver, the standard treatment is hepatic intra-arterial chemoembolization (TACE). In the event of failure of the latter or if the tumor dissemination progresses in the portal venous system or in the form of metastases, the systemic treatments are then indicated.
In 1st line, the reference treatment is a tyrosine kinase inhibitor (ITK) Sorafenib.
Read more
Cabozantinib obtained the European and French authorization (AMM) in November 2018 for its use in case of failure of Sorafenib in patients with HCC.
The main objective is the evaluation of the safety of Cabozantinib administered to patients with intermediate HCC ineligible for chemoembolization or advanced HCC after failure of Sorafenib and possibly another systemic anticancer line.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Cabozantinib group
- Keywords
- Hepatocellular carcinoma, Cabozantinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabozantinib groupDrug
The patient starts at 60 mg / day at a distance from meals In the event of intolerance to this dose of 60 mg; specific adapted measures will be taken according to the recommendations of the good practices of use of Cabozantinib within the framework of its MA. If the symptomatic treatments are not enough, each investigator can adapt the dose of Cabozantinib reducing it to 40 or even 20 mg / day Cabozantinib will be continued for as long as radiological and / or clinical benefit is observed for the patient (no progression of the disease) or until the occurrence of unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib group | Other | patients will receive Cabozantinib (within the framework of its MA) (an ECG is added) Receives: Drug: Cabozantinib group |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival of the patient after start of treatment
Overall Survival (OS) defined as the time (in months) between the start of treatment with Cabozantinib and the date of death from all causes; patients who are alive or lost to follow-up at the time of the analysis will be censored on the last follow-up date
Measured: Year 1
Secondary outcomes (3)
dosage modification for adverse effect
Incidence of changes in the dose of Cabozantinib for adverse effect during treatment (including daily dose reductions, dose spacings, discontinuation and permanent cessation of treatment for intolerance).
Measured: Year 1
Daily median dose of Cabozantinib
Daily median dose of Cabozantinib calculated between the start of treatment with Cabozantinib and the day of final cessation (including death)
Measured: Year 1
Number of patients with each dose of Cabozantinib
calculation of the number of patients with a dose of Cabozantinib 60 mg, 40 mg or 20 mg at the end of treatment or at the end of the study.
Measured: Year1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start9 Sep 2019
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT03963206
- Sponsor's protocol ID
- 69HCL18_0977
- Other IDs
- 2019-001142-18, 2019
- Acronym
- CLERANCE
- Status last verified
- Nov 2025
- First submitted
- 21 May 2019
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
P Merle - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma - Liver Cancer (Publication in progress)
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLERANCE HCC, Cabozantinib toLERANCE Study in HepatoCellular Carcinoma
- ClinicalTrials.gov ID
- NCT03963206
- Acronym / sponsor ID
- CLERANCE / 69HCL18_0977
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Cabozantinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 24 May 2019 (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 common tumor (the 8th leading cause of cancer in France) and has a poor prognosis. It is the 3rd leading cause of cancer deaths in the world. In the early stages (low tumor mass), HCC can be treated for curative purposes by surgical resection, percutaneous ablation or liver transplantation. When the tumor mass is larger (> 3 nodules) but remains confined to the liver, the standard treatment is hepatic intra-arterial chemoembolization (TACE). In the event of failure of the latter or if the tumor dissemination progresses in the portal venous system or in the form of metastases, the systemic treatments are then indicated.
In 1st line, the reference treatment is a tyrosine kinase inhibitor (ITK) Sorafenib.
Cabozantinib obtained the European and French authorization (AMM) in November 2018 for its use in case of failure of Sorafenib in patients with HCC.
The main objective is the evaluation of the safety of Cabozantinib administered to patients with intermediate HCC ineligible for chemoembolization or advanced HCC after failure of Sorafenib and possibly another systemic anticancer line.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib group | Other | Drug: Cabozantinib grouppatients will receive Cabozantinib (within the framework of its MA) (an ECG is added) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Major patient (age ≥ 18 years).
- Patient with a histologically proven HCC, or by radiology if cirrhotic liver (according to international recommendations).
- Patient with stage B BCLC classification after failure or impossibility of transarterial chemoembolization (TACE), or advanced stage C having already received one to two systemic lines, including one by Sorafenib.
- eastern cooperative oncology group score of 0 or 1 (ECOG).
- Child-Pugh A5 or A6 score.
Key exclusion criteria (20 listed)
- Patient with another cancer not cured or whose complete remission has been obtained for less than 2 years compared to the date of inclusion in CLERANCE.
- Patients eligible for surgical resection or radiofrequency ablation or liver transplantation or TACE according to international recommendations.
- Patient who has already had more than two lines of systemic treatment for his HCC (tyrosine kinase inhibitor, intravenous cytotoxic chemotherapy, immunotherapy, hormonal therapy for HCC).
- Patient who has never received Sorafenib in his previous systemic line (s).
- Patient who has already received a c-MET inhibitor.
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 |
|---|---|---|
| Cabozantinib groupThe patient starts at 60 mg / day at a distance from meals In the event of intolerance to this dose of 60 mg; specific adapted measures will be taken according to the recommendations of the good practices of use of Cabozantinib within the framework of its MA. If the symptomatic treatments are not enough, each investigator can adapt the dose of Cabozantinib reducing it to 40 or even 20 mg / day Cabozantinib will be continued for as long as radiological and / or clinical benefit is observed for the patient (no progression of the disease) or until the occurrence of unacceptable toxicity. | Drug | Cabozantinib group |
Primary outcome
survival of the patient after start of treatment
Time frame: Year 1
Overall Survival (OS) defined as the time (in months) between the start of treatment with Cabozantinib and the date of death from all causes; patients who are alive or lost to follow-up at the time of the analysis will be censored on the last follow-up date
3 secondary outcomes
dosage modification for adverse effect
Time frame: Year 1
Daily median dose of Cabozantinib
Time frame: Year 1
Number of patients with each dose of Cabozantinib
Time frame: Year1
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 1 Dec 2025.
- Results publicationP Merle - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma - Liver Cancer (Publication in progress)
- Individual participant dataSharing planned: Undecided
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cabozantinib group in people with Hepatocellular Carcinoma, run by Hospices Civils de Lyon at 18 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 16 inclusion and 20 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 1 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 18 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
survival of the patient after start of treatment (time frame: Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03963206, which also lists 1 linked publication.
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 1 Dec 2025.