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Hepatocellular carcinoma – Trials in Disease

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Clinical Trials for Hepatocellular Carcinoma

Hepatocellular carcinoma is the most common type of primary liver cancer. This article provides information about 66 ongoing clinical trials investigating new treatments for this condition. These trials are testing various approaches including immunotherapy, targeted therapy, radiation therapy, and combination treatments. Trials are being conducted across multiple European countries and other locations worldwide.

Clinical trial locations

Study of DNAJB1-PRKACA Peptide Vaccine for Patients with Fibrolamellar Hepatocellular Carcinoma and Other Tumors with Oncogenic Driver Fusion

This trial is testing a vaccine called Fusion-VAC-XS15 for patients with fibrolamellar hepatocellular carcinoma, a rare type of liver cancer, and other tumors with a specific genetic change. The vaccine is given through injection under the skin and aims to help the immune system recognize and fight cancer cells.

Main inclusion criteria: Patients must be at least 18 years old (12-17 years old can join after 6 adults), have confirmed fibrolamellar hepatocellular carcinoma or another cancer with the DNAJB1-PRKACA fusion, and have achieved complete remission through surgery or other treatments. Patients must have good performance status and adequate organ function.

Main exclusion criteria: Patients with medical conditions other than fibrolamellar hepatocellular carcinoma or tumors with the oncogenic driver fusion cannot participate. Pregnant or breastfeeding women are excluded, as are patients with serious health conditions or active infections.

Trial focus: The trial evaluates the vaccine’s ability to stimulate an immune response in patients with fibrolamellar hepatocellular carcinoma and similar cancers. It monitors immune system changes and cancer progression over time through regular assessments.

Investigational drug: Fusion-VAC-XS15 is a peptide vaccine targeting the DNAJB1-PRKACA fusion. The goal is to stimulate the immune system to recognize and attack cancer cells carrying this genetic abnormality.

Study of Drug Combinations Including Cisplatin for Children with Hepatoblastoma or Hepatocellular Carcinoma

This trial studies different chemotherapy medication combinations for children with liver cancer. The treatments include cisplatin, carboplatin, doxorubicin, fluorouracil, vincristine, etoposide, irinotecan, gemcitabine, oxaliplatin, and sorafenib. Most medications are given through infusion, while sorafenib is taken orally.

Main inclusion criteria: Age must be 30 years or younger with a clinical or confirmed diagnosis of hepatoblastoma or hepatocellular carcinoma. Patients must have good heart function, adequate blood counts, and good kidney function.

Main exclusion criteria: Patients not meeting the age range or without the specified liver cancers cannot participate. Those with severe heart, kidney, or liver problems (beyond the cancer being studied) are excluded, as are patients with active infections or those who are pregnant or breastfeeding.

Trial focus: The study divides patients into groups based on their specific type of liver cancer and risk level, testing different medication combinations to find which work best while monitoring side effects.

Investigational drugs: The trial uses multiple chemotherapy drugs including platinum-based agents (cisplatin, carboplatin, oxaliplatin), anthracyclines (doxorubicin), and other agents (fluorouracil, vincristine, etoposide, irinotecan, gemcitabine), plus the targeted therapy sorafenib.

Study of Durvalumab and Tremelimumab with Y-90 SIRT for Intermediate Stage Liver Cancer

This trial combines immunotherapy drugs (durvalumab and tremelimumab) with Y-90 SIRT, a radiation therapy that targets liver tumors. The medications are given as intravenous infusions.

Main inclusion criteria: Patients must have intermediate-stage hepatocellular carcinoma that cannot be treated with surgery or local therapies but is suitable for TACE treatment. They must have good liver function (Child-Pugh Class A or B7) and ECOG performance status of 0 or 1.

Main exclusion criteria: Patients with severe heart problems, uncontrolled high blood pressure, active infections, or who are pregnant/breastfeeding cannot participate. Those with autoimmune diseases or history of severe allergic reactions to similar medications are excluded.

Trial focus: The study evaluates whether adding immunotherapy to Y-90 SIRT radiation therapy can improve outcomes for patients with intermediate-stage liver cancer that cannot be surgically removed.

Investigational drugs: Durvalumab and tremelimumab are immunotherapy drugs that help the immune system recognize and attack cancer cells by blocking proteins that prevent immune response.

Study of Durvalumab, Tremelimumab, and Bevacizumab for Non-Resectable Liver Cancer

This trial tests a combination of three medications: durvalumab and tremelimumab (immunotherapy drugs) with bevacizumab (which blocks blood vessel growth in tumors). All medications are given as intravenous infusions.

Main inclusion criteria: Patients must have advanced hepatocellular carcinoma that cannot be surgically removed, confirmed by tests. They must not have received previous systemic therapy for HCC. Patients need Child-Pugh Class A liver function and ECOG performance status of 0 or 1.

Main exclusion criteria: Patients with other serious health conditions, severe heart problems, active infections, or who are pregnant/breastfeeding cannot participate. Those with autoimmune diseases or brain metastases requiring treatment are excluded.

Trial focus: The study evaluates whether this three-drug combination can improve survival and control cancer growth in patients with non-resectable liver cancer who haven’t had previous systemic treatment.

Investigational drugs: Durvalumab and tremelimumab help the immune system attack cancer cells, while bevacizumab blocks blood vessel growth that feeds tumors.

Study of E7386 and Lenvatinib for Liver, Colon, Endometrial, or Other Solid Tumors

This trial studies E7386, an investigational tablet medication, combined with Lenvima (lenvatinib) hard capsules for various solid tumors including hepatocellular carcinoma. Both medications are taken orally.

Main inclusion criteria: Patients must have adequate blood and organ function and at least one measurable tumor. For HCC patients specifically, they must have confirmed diagnosis that is unresectable and no previous systemic anti-cancer treatment.

Main exclusion criteria: Patients with severe or uncontrolled medical conditions, recent major surgery, significant heart conditions, or active infections cannot participate. Pregnant or breastfeeding women are excluded.

Trial focus: The study aims to determine the best dose of E7386 when combined with lenvatinib and assess its effectiveness in treating various solid tumors including liver cancer.

Investigational drugs: E7386 is an investigational tablet targeting specific cancer cell pathways. Lenvatinib blocks proteins that help cancer cells grow and spread.

Study on Livmoniplimab and Budigalimab for Advanced Liver Cancer Without Prior Systemic Treatment

This trial evaluates two medications, livmoniplimab and budigalimab, given as intravenous infusions for advanced or metastatic liver cancer patients who haven’t received previous systemic treatment.

Main inclusion criteria: Patients must be at least 18 years old with advanced or metastatic hepatocellular carcinoma that cannot be surgically removed. They must have Child-Pugh Class A or B liver function, ECOG performance status of 0 or 1, and no previous systemic treatment for HCC.

Main exclusion criteria: Patients with active or untreated brain metastases, active autoimmune disease, uncontrolled high blood pressure, or serious infections cannot participate. Those with other active cancers requiring treatment or who are pregnant/breastfeeding are excluded.

Trial focus: The study has two stages: first determining the optimal dose of livmoniplimab combined with budigalimab, then assessing the combination’s effectiveness and safety in improving overall survival.

Investigational drugs: Livmoniplimab and budigalimab are immunotherapy medications that work by helping the immune system recognize and attack cancer cells.

Study on Atezolizumab and Bevacizumab for Intermediate-Stage Liver Cancer

This trial compares the combination of atezolizumab and bevacizumab (both given as intravenous infusions) with transarterial chemoembolization (TACE) for intermediate-stage liver cancer.

Main inclusion criteria: Patients must have intermediate-stage hepatocellular carcinoma confirmed by medical imaging or tissue tests that cannot be treated with surgery or liver transplant but can be treated with TACE. They must have Child-Pugh score A or B7 and ECOG performance status of 0-1.

Main exclusion criteria: Patients with severe heart problems, uncontrolled high blood pressure, active infections, or who are pregnant/breastfeeding cannot participate. Those with other serious medical conditions or participating in other clinical trials are excluded.

Trial focus: The study aims to determine if the combination of atezolizumab and bevacizumab provides better outcomes than TACE alone for intermediate-stage liver cancer over a two-year period.

Investigational drugs: Atezolizumab helps the immune system attack cancer cells, while bevacizumab blocks blood vessel growth that feeds tumors.

Study on Atezolizumab and Bevacizumab for Unresectable Liver Cancer

This trial evaluates atezolizumab and bevacizumab (intravenous infusions) alone or combined with selective transarterial chemoembolization (sdTACE) for unresectable liver cancer.

Main inclusion criteria: Patients must be 18 years or older with hepatocellular carcinoma that cannot be treated with surgery or local treatments but is suitable for TACE, with less than 50% of liver affected. They must have at least one untreated measurable tumor, ECOG performance status of 0 or 1, and Child-Pugh class A or B7.

Main exclusion criteria: Patients with severe liver disease other than cancer, heart conditions, active infections, or who are pregnant/breastfeeding cannot participate. Those with uncontrolled high blood pressure or drug/alcohol abuse are excluded.

Trial focus: The study compares starting with atezolizumab and bevacizumab and adding TACE if disease progresses versus starting all treatments together to determine the best approach.

Investigational drugs: Atezolizumab is an immune checkpoint inhibitor, and bevacizumab is an angiogenesis inhibitor that blocks tumor blood vessel growth.

Study on Atezolizumab, Bevacizumab, and EXL01 for Liver Cancer Not Responding to First-Line Immunotherapy

This trial combines atezolizumab and bevacizumab (intravenous infusions) with EXL01 (oral bacterial supplement capsule) for patients whose liver cancer progressed despite initial immunotherapy.

Main inclusion criteria: Patients must be 18 years or older with hepatocellular carcinoma confirmed by biopsy or imaging, showing partial or complete response after 6 months of atezolizumab/bevacizumab treatment. They need Child-Pugh A liver function, ECOG performance status of 0 or 1, and adequate organ function.

Main exclusion criteria: Patients with other types of cancer, severe heart problems, active infections, or who are pregnant/breastfeeding cannot participate. Those with autoimmune diseases or recent major surgery are excluded.

Trial focus: The study evaluates whether adding bacterial supplementation to standard immunotherapy can improve outcomes for patients with liver cancer, tracking tumor response and survival over 12 months.

Investigational drugs: Atezolizumab and bevacizumab are immunotherapy/anti-angiogenic medications, while EXL01 is a bacterial supplement aimed at improving immune response.

Study on Durvalumab and Tremelimumab for Liver Cancer Patients Undergoing Electroporation Ablation

This trial evaluates durvalumab and tremelimumab (intravenous infusions) given before and after irreversible electroporation ablation procedure for hepatocellular carcinoma patients.

Main inclusion criteria: Patients must be 18 years or older with newly diagnosed or recurrent HCC meeting specific size criteria and eligible for IRE procedure. They must have adequate organ function, ECOG performance status of 0-1, and life expectancy of at least 3 months.

Main exclusion criteria: Patients with other cancers in the past 5 years, severe heart disease, active infections, autoimmune diseases, or who are pregnant/breastfeeding cannot participate. Those with history of organ transplant are excluded.

Trial focus: The study assesses the safety and effectiveness of combining immunotherapy with electroporation ablation, monitoring for cancer recurrence and survival over one year.

Investigational drugs: Durvalumab and tremelimumab are immunotherapy drugs that help the immune system recognize and attack cancer cells by blocking specific suppressive proteins.

Summary

This overview covers 66 ongoing clinical trials for hepatocellular carcinoma across multiple European countries and other locations. The trials represent diverse treatment approaches including immunotherapy combinations, targeted therapies, radiation therapies, and novel treatment strategies.

Several notable observations emerge from these trials. Immunotherapy-based treatments feature prominently, with many trials testing combinations of checkpoint inhibitors like atezolizumab, durvalumab, nivolumab, and tremelimumab. These are frequently combined with anti-angiogenic agents like bevacizumab or lenvatinib. Germany, France, Italy, and Spain show the highest concentration of trial activity, reflecting strong oncology research infrastructure in these countries.

Many trials focus on specific patient populations, such as those with intermediate-stage disease, patients who haven’t received previous systemic therapy, or those whose cancer has progressed after initial treatment. Several innovative approaches are being studied, including fecal microbiota transplantation, peptide vaccines, and novel radiation therapy techniques.

The trials typically require good liver function (Child-Pugh A or B), adequate performance status (ECOG 0-1), and exclude patients with severe comorbidities or active infections. Most trials are investigating first-line or second-line treatment options for advanced or unresectable hepatocellular carcinoma.

Ongoing Clinical Trials on Hepatocellular carcinoma

  • Study of Durvalumab and Tremelimumab with Y-90 SIRT for Patients with Intermediate Stage Liver Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Lenvatinib for Patients with Poor-Prognosis Hepatocellular Carcinoma Undergoing Percutaneous Ablation Therapy

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Atezolizumab and Bevacizumab for Patients with Intermediate-Stage Liver Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy Spain

  • Study on Atezolizumab and Bevacizumab for Patients with Small Hepatocellular Carcinoma Undergoing Radiofrequency Ablation

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of E7386 and Lenvatinib for Patients with Liver, Colon, Endometrial, or Other Solid Tumors

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

  • Study on Advanced Liver Cancer: Evaluating Livmoniplimab and Budigalimab in Patients Without Prior Systemic Treatment

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on the Effects of Cannabis Oil (Dronabinol and Cannabidiol) for Patients with Untreatable Advanced Liver Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Safe Skin Test Concentrations for Biotherapy Allergies in Patients with Cancer Using Atezolizumab, Daratumumab, and Nivolumab

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Safety and Effectiveness of CEB-01 for Children with Resectable Tumors

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on 68Ga-FAPI-46 PET Imaging for Patients with Gastrointestinal Cancers

    Not yet recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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