Study on hepatocellular carcinoma treatment using transarterial chemoembolization and drug therapy

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    What is this study about?

    This international study is testing new treatments for hepatocellular carcinoma. Patients will receive transarterial chemoembolization (TACE) or TACE combined with drugs like durvalumab, tremelimumab, and lenvatinib. The main objective is to assess the efficacy and safety of combining transarterial chemoembolization (TACE) with the immunotherapy drugs durvalumab and tremelimumab, and possibly drug lenvatinib. TACE involves injecting chemo and embolic agents directly into the liver’s blood vessels. The new drug combination is given through IV and pills. The main goal is to see if adding these drugs to TACE helps slow down cancer progression and improves survival.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Brussels , Belgium

      Gent , Belgium

      Angers , France

      Clichy , France

      Creteil , France

      MONTPELLIER Cedex 5 , France

      Nantes cedex 1 , France

      Nice , France

      Paris , France

      Strasbourg , France

      Toulouse , France

      Vandoeuvre Les Nancy , France

      Bonn , Germany

      Chemnitz , Germany

      Dresden , Germany

      Du00fcsseldorf , Germany

      Frankfurt , Germany

      Gu00f6ttingen , Germany

      Hamburg , Germany

      Hannover , Germany

      Heidelberg , Germany

      Kiel , Germany

      Leipzig , Germany

      Magdeburg , Germany

      Ulm , Germany

      Arezzo , Italy

      Firenze , Italy

      Milano , Italy

      Milano , Italy

      Roma , Italy

      Rozzano , Italy

      Tricase , Italy

      Lisboa , Portugal

      Vila Real , Portugal

      Barcelona , Spain

      Barcelona , Spain

      Cordoba , Spain

      Madrid , Spain

      Madrid , Spain

      San Sebastian , Spain

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The study you are inquiring about is a Phase III, randomized, open-label clinical trial designed to assess the efficacy and safety of different combinations of drugs and procedures in participants with locoregional hepatocellular carcinoma (HCC) that is not amenable to curative therapy like surgical resection, transplantation, or ablation. The trial is structured into three arms:

      1. Arm A: Patients receive Tremelimumab, Durvalumab, and Lenvatinib in combination with Transarterial Chemoembolization (TACE).
      2. Arm B: Patients receive Tremelimumab and Durvalumab in combination with TACE.
      3. Arm C: Patients receive TACE alone as the active comparator.

      Each arm involves different interventions, such as drugs administered intravenously (IV) or orally, and procedures like TACE, which involves the injection of chemo and embolic agents into the hepatic artery. The exact steps that patients need to take, including dosage and duration, will be specified by the clinical trial protocol and the healthcare professionals overseeing the patient’s care in the trial.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you must have a specific profile of liver disease. The Inclusion Criteria relevant to diseases are as follows:

      1. No evidence of extrahepatic disease.
      2. Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to Transarterial Chemoembolization (TACE).
      3. Child Pugh score class A, which is a scoring system used to assess the prognosis of chronic liver disease, particularly cirrhosis.
      4. Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria, indicating the presence of tumor(s) that can be accurately measured in at least one dimension.
      5. Adequate organ and marrow function.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following inclusion criteria:

      1. No evidence of extrahepatic disease: This means there should be no signs that the disease has spread outside of the liver.
      2. Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE: TACE stands for Transarterial Chemoembolization, a procedure where chemotherapy and embolic agents are injected directly into the liver’s arteries. Your disease must not be treatable by surgery, transplant, or ablation, which are other forms of curative treatments.
      3. Child Pugh score class A: The Child-Pugh score is a system used to assess the severity and prognosis of chronic liver disease and cirrhosis. Class A represents the least severe stage with the best prognosis.
      4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment: The ECOG Performance Status is a measure of your ability to perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some restrictions but are still up and about more than 50% of waking hours.
      5. Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria: The mRECIST criteria are used to assess response to treatment in solid tumors by measuring the size of the tumor. Your disease must have measurable indicators that can be tracked over time to establish treatment efficacy.
      6. Adequate organ and marrow function: This means your organs, including your liver, kidneys, and bone marrow, must function within certain medical standards to support treatment.

      These criteria must be met without considering exclusion criteria.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      • Symptomatic congestive heart failure: A condition where the heart does not pump blood as well as it should, leading to symptoms such as shortness of breath, fatigue, and swelling in the legs.
      • Unstable angina pectoris: A form of chest pain due to reduced blood flow to the heart that is variable and unpredictable.
      • Uncontrolled cardiac arrhythmia: Irregular heartbeats that are not well managed or are erratic, which can affect the heart’s efficiency.
      • History of hepatic encephalopathy: A decline in brain function because of severe liver disease, often leading to confusion, altered level of consciousness, and coma.
      • Major portal vein thrombosis visible on baseline imaging: A blood clot in the portal vein, which can block blood flow to the liver, seen on initial scans.
      • Uncontrolled arterial hypertension: High blood pressure that isn’t controlled with medication or other treatments.
      • Co-infection with HBV and HDV: Having both hepatitis B virus (HBV) and hepatitis D virus (HDV) simultaneously, which can worsen the illness.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are as follows:

      1. Tremelimumab – This is an active substance administered intravenously (IV) and is used in Arm A and Arm B of the study.
      2. Durvalumab – Another active substance given via intravenous (IV) administration. Like Tremelimumab, Durvalumab is included in Arms A and B.
      3. Lenvatinib (trade name: Lenvima) – This oral medication is only used in Arm A of the study in combination with Transarterial Chemoembolization (TACE).

      The descriptions provided in the document are brief with regard to the mode of delivery, but if you are interested in more detailed information about each active substance, that would require a separate search as it does not seem to be included in the provided study document. Would you like me to provide general descriptions of these active substances?

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are known to medicine and the medical literature. Below is the list of substances with a description for each:

      1. Tremelimumab (MEDI1123): Tremelimumab is administered intravenously (IV). It is a monoclonal antibody that works as an immune checkpoint inhibitor, targeting CTLA-4, a molecule on T cells that plays a significant role in regulating natural immune responses. Tremelimumab has been studied in various cancers and is known to the medical community.
      2. Durvalumab (MEDI4736): Durvalumab is also administered intravenously. It is an immunotherapy drug known as a checkpoint inhibitor, specifically targeting PD-L1. Durvalumab is used in the treatment of certain types of cancers, such as urothelial carcinoma and non-small cell lung cancer, and has been researched and documented in medical literature.
      3. Lenvatinib (Lenvima): Lenvatinib is an oral drug that acts as a multiple kinase inhibitor. It is used for the treatment of certain kinds of thyroid cancer and renal cell carcinoma. Lenvatinib works by inhibiting the vascular endothelial growth factor (VEGF) receptors, among others, which play a role in tumor angiogenesis. It is a well-known medication with an established presence in medical literature.

      Study ID

      CT-EU-00029556

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III