New hope for liver cancer patients: cabozantinib safety trial shows promise

NCT ID NCT03963206

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

110 people

The number who actually took part.

Started

Sep 2019

Finished

Oct 2021

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • APHM - Timone

    Marseille, France

  • APHP - Hôpital St Antoine

    Paris, France

  • CHRU Rennes site pontchaillou

    Rennes, France

  • CHRU de Lille-Hôpital Claude Huriez

    Lille, France

  • CHU Amiens Picardie - Hôpital Sud

    Amiens, France

  • CHU Dupuytren

    Limoges, France

  • CHU Jean Minjoz

    Besançon, France

  • CHU Toulouse PURPAN

    Toulouse, France

  • CHU de St Etienne

    Saint-Priest-en-Jarez, France

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, France

  • Centre Hospitalier de Boulogne sur mer

    Boulogne-sur-Mer, France

  • Centre hospitalier universitaire Côte de nacre

    Caen, France

  • Hospices Civils de Lyon - Hôpital de la Croix Rousse

    Lyon, 69004, France

  • Hôpital Avicenne

    Bobigny, France

  • Hôpital Beaujon

    Clichy, France

  • Hôpital Brabois adulte - CHU de Nancy

    Vandœuvre-lès-Nancy, France

  • Hôpital Robert Debré - CHU de Reims

    Reims, France

  • Hôpital haut- lévêque

    Pessac, France

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