New hope for liver cancer patients: cabozantinib safety trial shows promise
NCT ID NCT03963206
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how safe the drug cabozantinib is for people with advanced liver cancer (hepatocellular carcinoma) who have already tried another treatment called sorafenib. A total of 110 adults took part. The main goal was to see how long patients lived after starting cabozantinib and to track any side effects that required changing the dose.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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110 people
The number who actually took part.
- Started
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Sep 2019
- Finished
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Oct 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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APHM - Timone
Marseille, France
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APHP - Hôpital St Antoine
Paris, France
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CHRU Rennes site pontchaillou
Rennes, France
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CHRU de Lille-Hôpital Claude Huriez
Lille, France
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CHU Amiens Picardie - Hôpital Sud
Amiens, France
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CHU Dupuytren
Limoges, France
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CHU Jean Minjoz
Besançon, France
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CHU Toulouse PURPAN
Toulouse, France
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CHU de St Etienne
Saint-Priest-en-Jarez, France
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Centre Hospitalier Universitaire de Montpellier
Montpellier, France
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Centre Hospitalier de Boulogne sur mer
Boulogne-sur-Mer, France
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Centre hospitalier universitaire Côte de nacre
Caen, France
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Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, 69004, France
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Hôpital Avicenne
Bobigny, France
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Hôpital Beaujon
Clichy, France
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Hôpital Brabois adulte - CHU de Nancy
Vandœuvre-lès-Nancy, France
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Hôpital Robert Debré - CHU de Reims
Reims, France
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Hôpital haut- lévêque
Pessac, France
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Other studies related to the condition(s) this trial covers.
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- AI-Enhanced ultrasound aims to catch liver cancer earlier
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- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial