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.
Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma | Drug: Cabozantinib group | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | CLERANCE HCC, Cabozantinib toLERANCE Study in HepatoCellular Carcinoma |
Actual Study Start Date : | September 9, 2019 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | November 2021 |
Arm | Intervention/treatment |
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Cabozantinib group
patients will receive Cabozantinib (within the framework of its MA) (an ECG is added)
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Drug: Cabozantinib group
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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Tracking Information | |||||
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First Submitted Date ICMJE | May 21, 2019 | ||||
First Posted Date ICMJE | May 24, 2019 | ||||
Last Update Posted Date | November 24, 2020 | ||||
Actual Study Start Date ICMJE | September 9, 2019 | ||||
Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) | ||||
Official Title ICMJE | CLERANCE HCC, Cabozantinib toLERANCE Study in HepatoCellular Carcinoma | ||||
Brief 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 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hepatocellular Carcinoma | ||||
Intervention ICMJE | Drug: Cabozantinib group
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.
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Study Arms ICMJE | Cabozantinib group
patients will receive Cabozantinib (within the framework of its MA) (an ECG is added)
Intervention: Drug: Cabozantinib group
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
110 | ||||
Original Estimated Enrollment ICMJE |
170 | ||||
Estimated Study Completion Date ICMJE | November 2021 | ||||
Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
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.
Exclusion Criteria:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03963206 | ||||
Other Study ID Numbers ICMJE | 69HCL18_0977 2019-001142-18 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hospices Civils de Lyon | ||||
Study Sponsor ICMJE | Hospices Civils de Lyon | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Hospices Civils de Lyon | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |