Hepatic cancer – Trials in Disease

Go back

Ongoing Clinical Trials for Hepatic Cancer

This article provides detailed information about 9 ongoing clinical trials for hepatic cancer (also known as: liver cancer, hepatocellular carcinoma). These trials are testing various treatments including immunotherapies, targeted therapies, and innovative diagnostic approaches across multiple countries in Europe.

Clinical trial locations

Study on Indocyanine Green for Better Detection of Liver Tumors in Patients Undergoing Minimally Invasive Liver Surgery

This trial, conducted in Spain, is investigating an innovative approach to improve tumor detection during minimally invasive surgery. The study focuses on using Indocyanine Green, a special dye that makes tumors glow under infrared light, to help surgeons better identify and locate cancerous tissue during surgery.

Inclusion criteria: Patients must have confirmed liver tumors requiring minimally invasive surgery, as evaluated by the hospital’s multidisciplinary liver tumor board. Participants need to have had a contrast-enhanced MRI within 6 weeks before surgery and must be at least 18 years old. They should be able to provide informed consent for data collection and analysis.

Exclusion criteria: Patients who are not undergoing minimally invasive surgery, those without liver tumors, patients outside the specified age range, or those considered part of a vulnerable population are excluded from the study.

Study focus: The main goal is to evaluate how effectively the combination of Indocyanine Green fluorescence, intraoperative ultrasound, and preoperative MRI can detect liver tumors during surgery. Researchers are also developing a machine-learning algorithm to analyze photographs of the liver during surgery, helping to automatically identify tumors. This could make it easier for surgeons to find and remove all cancerous tissue.

Investigational drug: Indocyanine Green is administered intravenously before surgery. When exposed to near-infrared light during the operation, it causes tumors to fluoresce, making them easier to see and locate.

Study of cabozantinib with atezolizumab compared to sorafenib in untreated patients with advanced liver cancer (hepatocellular carcinoma)

This international trial, taking place in Spain, France, Belgium, Hungary, and Romania, compares two different treatment approaches for patients who have not yet received treatment for advanced hepatocellular carcinoma. The study evaluates whether combining two newer medications works better than a single standard treatment.

Inclusion criteria: Participants must be at least 18 years old with confirmed advanced hepatocellular carcinoma that cannot be cured through surgery, transplant, or local treatments. They need to have measurable cancer on imaging scans, intermediate or advanced stage disease, good liver function (Child-Pugh Score A), and be able to perform most daily activities with minimal assistance.

Exclusion criteria: Patients who have already received systemic treatment for their cancer, those with brain metastases, organ transplant recipients, individuals with recent significant bleeding, uncontrolled high blood pressure, major recent surgery, severe heart conditions, active autoimmune disease, current immunosuppressive medication use, active hepatitis B or C, HIV infection, pregnancy or breastfeeding, and known allergies to study medications are excluded.

Study focus: The trial compares the combination of cabozantinib and atezolizumab against sorafenib alone. The main goal is to determine which approach is more effective in treating advanced hepatocellular carcinoma by measuring overall survival, cancer response rates, and quality of life.

Investigational drugs: Cabozantinib is an oral targeted therapy that blocks proteins helping cancer cells grow and form blood vessels. Atezolizumab is an immunotherapy given through intravenous infusion that helps the immune system recognize and attack cancer cells. Sorafenib is a standard oral targeted therapy for advanced hepatocellular carcinoma.

Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors

Conducted across France, Italy, Spain, Czechia, Germany, and Denmark, this trial is specifically designed for children and young adults with challenging tumors that have either returned after treatment or have not responded to previous therapies. While not exclusively focused on hepatic cancer, the trial may include young patients with liver tumors.

Inclusion criteria: Participants must be children or young adults (specific age ranges vary by cohort, from 0 to less than 21 years) with advanced or metastatic solid tumors that have worsened after available therapies. They need at least one measurable lesion and adequate organ function based on specific blood test results. Participants must have a performance status of 60% or higher and provide written informed consent.

Exclusion criteria: Patients who have not recovered from previous treatments, those with other serious uncontrolled illnesses, pregnant or breastfeeding participants, those with another cancer within the last 5 years (with specific exceptions), organ transplant recipients, individuals with known drug allergies, those taking other experimental drugs, patients with active infections requiring treatment, certain heart conditions, lung diseases, neurological or psychiatric disorders, recent live vaccine recipients, autoimmune disease history, and drug or alcohol abuse history are excluded.

Study focus: The trial aims to determine the safety, tolerability, and appropriate dosage of combining cobolimab and dostarlimab in young patients. It also explores how these medications work in the body and their effectiveness against tumors. The study is divided into two parts: dose-finding and efficacy evaluation in specific tumor types.

Investigational drugs: Both cobolimab and dostarlimab are immunotherapy medications administered through intravenous infusion. They work by helping the immune system better recognize and attack cancer cells.

Study of Pembrolizumab and Lenvatinib for Patients with Advanced Liver Cancer Resistant to Previous Immunotherapy

This German trial focuses on patients with advanced hepatocellular carcinoma who have already tried immunotherapy-based treatment but experienced disease progression. The study evaluates a new combination approach for these patients who have limited remaining treatment options.

Inclusion criteria: Participants must have confirmed hepatocellular carcinoma with at least one measurable site of disease, be at least 18 years old, and have experienced disease progression after at least 4 cycles or 12 weeks of first-line immunotherapy-based treatment. They need adequate organ function, good performance status (0-1), life expectancy of at least 12 weeks, controlled blood pressure, and a Child-Pugh Classification score of 6 or less. The tumor must be inoperable or unsuitable for local ablation.

Exclusion criteria: Patients with any other type of cancer, those who received cancer treatment within the last 4 weeks, individuals with severe heart problems or uncontrolled high blood pressure, active infections (including HIV, hepatitis B, or hepatitis C), pregnant or breastfeeding women, those with severe allergic reaction history to similar drugs, and individuals with other serious medical conditions that could interfere with the study are excluded.

Study focus: The trial evaluates the combination of pembrolizumab and lenvatinib in patients whose cancer has progressed despite previous immunotherapy. The main goal is to measure the objective response rate (how many patients experience tumor shrinkage or disappearance) and overall survival. The study will last up to 24 months with regular monitoring.

Investigational drugs: Pembrolizumab is an immunotherapy given through intravenous infusion that blocks a protein called PD-1, allowing the immune system to better attack cancer cells. Lenvatinib is an oral targeted therapy (capsules) that blocks proteins promoting blood vessel growth in tumors, effectively starving cancer cells.

Study on Adding Ipilimumab to Atezolizumab and Bevacizumab for Patients with Liver Cancer Receiving First-Line Treatment

This French trial investigates whether adding a third medication to a standard two-drug combination can improve outcomes for patients receiving their first systemic therapy for hepatocellular carcinoma. The study compares these approaches to determine the most effective first-line treatment strategy.

Inclusion criteria: Participants must be at least 18 years old with confirmed hepatocellular carcinoma (biopsy required within the last two years). They need a WHO performance status of 0 or 1, and their cancer must not be treatable by surgery, heat treatment, liver transplant, or certain palliative treatments. Patients must have advanced or intermediate stage disease after failure or inability to use specific prior treatments, normal Troponin-T levels, no visible ascites or history of encephalopathy, adequate liver, blood, and kidney function, controlled heart disease for at least 6 months, at least one measurable tumor, and recent esophageal endoscopy.

Exclusion criteria: Patients with a different type of cancer, those who received cancer treatment within the last 4 weeks, individuals with severe heart problems, uncontrolled high blood pressure, active infections (including HIV or hepatitis), pregnant or breastfeeding women, those with severe allergic reaction history to similar medications, significant liver disease other than hepatocellular carcinoma, major surgery within the last 4 weeks, drug or alcohol abuse within the last 6 months, and those unable to follow study procedures are excluded.

Study focus: The study evaluates whether adding ipilimumab to the combination of atezolizumab and bevacizumab improves overall survival compared to the two-drug combination alone. Secondary goals include assessing cancer response, progression-free survival, and quality of life over a 24-month period.

Investigational drugs: All three medications are given through intravenous infusion. Ipilimumab and atezolizumab are immune checkpoint inhibitors that help the immune system attack cancer cells through different mechanisms. Bevacizumab blocks blood vessel growth that supplies nutrients to tumors.

Study on Atezolizumab for Patients with Lung and Liver Cancer Using Digital Health Solutions

This trial, conducted in Germany, Spain, and Austria, explores how digital health technology can improve care for patients receiving immunotherapy treatment. While primarily focused on lung cancer, the study includes patients with advanced or unresectable hepatocellular carcinoma and investigates home-based treatment administration.

Inclusion criteria: Participants must have an email address, internet-connected device, and internet access. They should have confirmed diagnosis of their condition through local laboratory tests. For patients with hepatocellular carcinoma (Cohort A), they need an ECOG performance status of 0, 1, or 2 and life expectancy of at least 12 weeks.

Exclusion criteria: Patients with cancers other than those specified in the study, those outside the specified age range, individuals unable to follow study procedures, those with medical conditions making participation unsafe, pregnant or breastfeeding women, participants in another concurrent clinical trial, those planning or recently having major surgery, active infections requiring treatment, severe allergic reaction history to study medications, and mental health conditions interfering with participation are excluded.

Study focus: The trial evaluates how digital patient monitoring systems can help manage symptoms for those receiving atezolizumab. It assesses the feasibility of combining digital monitoring with home-based treatment administration. The main goal is to measure changes in symptom interference after 12 weeks of treatment and monitor healthcare resource utilization.

Investigational drug: Atezolizumab is an immunotherapy medication administered subcutaneously (under the skin) in this study, allowing for home-based treatment. It works by blocking a protein that prevents the immune system from attacking cancer cells.

Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or Esophageal Cancer

This trial, taking place in the Netherlands, France, Spain, and Belgium, tests a three-drug combination across multiple types of solid tumors, including hepatocellular carcinoma. The study evaluates whether combining these medications with different mechanisms of action can improve treatment outcomes.

Inclusion criteria: Participants must have advanced or metastatic solid tumors (including hepatocellular carcinoma) that cannot be surgically removed or have spread to other body parts. They need at least one measurable tumor and must provide tumor tissue samples. For hepatocellular carcinoma specifically, patients must not have had any previous chemotherapy or certain other cancer treatments. Participants must be at least 18 years old.

Exclusion criteria: The trial excludes patients who do not have one of the specified cancer types.

Study focus: The study evaluates the safety and effectiveness of the three-drug combination (pembrolizumab, lenvatinib, and belzutifan). Regular monitoring assesses tumor response, side effects, and overall health status. The goal is to understand whether this combination offers benefits for treating various solid tumors, potentially leading to new treatment options.

Investigational drugs: Pembrolizumab is an immunotherapy given through intravenous infusion that helps the immune system recognize and attack cancer cells. Lenvatinib is an oral targeted therapy (capsules) that blocks proteins involved in cancer cell growth. Belzutifan is an oral medication (tablets) that works by inhibiting a protein helping cancer cells survive in low-oxygen environments.

Study on the Safety of Ibuprofen for Patients Experiencing Pain After Hip and Knee Replacement Surgery

This Danish trial is not directly related to hepatic cancer but is included in the source data. It focuses on pain management after orthopedic surgery and evaluates the safety of using ibuprofen for postoperative pain control.

Inclusion criteria: Participants must be scheduled for planned primary hip or knee replacement surgery (including partial hip replacement), be at least 18 years old, and have pain treatment plans including NSAID medication. Women of childbearing age must have negative pregnancy tests and agree to use contraception. Written informed consent is required.

Exclusion criteria: Patients with ibuprofen or NSAID allergy history, stomach ulcers or bleeding history, severe heart/liver/kidney problems, pregnancy or breastfeeding, medications that may interact with ibuprofen (such as blood thinners), asthma triggered by aspirin or NSAIDs, bleeding disorders, recent heart attack or stroke, uncontrolled high blood pressure, and inflammatory bowel disease are excluded.

Study focus: The trial assesses the safety of using ibuprofen for eight days after major hip and knee surgeries. It monitors for serious health issues within 90 days after surgery and tracks side effects compared to those from other pain medications.

Investigational drug: Ibuprofen is a common non-opioid pain reliever and anti-inflammatory medication taken orally as tablets. It works by blocking substances in the body that cause inflammation and pain.

Study on WT1/IL15/IL15Ra mRNA DC Vaccine for Patients with Advanced or Refractory Solid Tumors of the Pancreas, Esophagus, Liver, or Ovaries

This Belgian trial explores an innovative personalized vaccine approach for patients with advanced solid tumors, including hepatocellular carcinoma. The vaccine is made from the patient’s own cells and designed to help the immune system better recognize and fight cancer.

Inclusion criteria: Participants must have confirmed solid tumors in the pancreas, esophagus, liver, or ovaries that are advanced, recurrent, or worsening after at least one anti-cancer treatment. Alternative standard therapy options should either be unavailable, not tolerated, or refused by the patient. They need at least one measurable or evaluable lesion, reasonable life expectancy of at least 3 months, be 18 years or older, have WHO performance status between 0 and 2, and adequate blood and organ function.

Exclusion criteria: Patients without tumors in the specified organs, those whose tumors are not advanced/recurrent/progressing after treatment, individuals with available alternative standard therapy options who are neither intolerant nor refusing treatment, those outside the specified age range, and participants not part of the specified clinical trial groups are excluded.

Study focus: The trial evaluates the safety and feasibility of producing and administering a personalized vaccine made from the patient’s own white blood cells. The vaccine is designed to target a specific protein found in some cancer cells. The study monitors vaccine safety, clinical efficacy, quality of life, and immune response throughout the treatment period.

Investigational drug: The WT1/IL15/IL15Ra mRNA DC vaccine is a personalized immunotherapy administered through intradermal injection (just under the skin). It uses dendritic cells modified to target the Wilms’ tumor protein 1 and present interleukin-15, aiming to stimulate the immune system to attack cancer cells.

Summary

The 9 ongoing clinical trials for hepatic cancer demonstrate a strong focus on immunotherapy and targeted therapy approaches. Several trials evaluate combinations of immunotherapy medications, such as atezolizumab with cabozantinib or bevacizumab, and pembrolizumab with lenvatinib. This reflects the current trend in cancer treatment toward using multiple medications that work through different mechanisms to improve outcomes.

Geographically, the trials are concentrated in Western European countries, with Spain, France, Belgium, and Germany hosting multiple studies. This distribution provides patients in these regions with greater access to innovative treatment options. Several trials are international, spanning multiple countries, which helps gather diverse patient data and accelerate research progress.

A notable feature is the inclusion of trials exploring innovative approaches beyond standard medication combinations. These include the use of Indocyanine Green for improved surgical tumor detection, digital health solutions for remote patient monitoring, and personalized vaccine therapy. These studies represent important steps toward more precise and patient-centered cancer care.

The trials address different patient populations, from those receiving first-line treatment to patients whose cancer has progressed after previous therapies. This comprehensive approach ensures research is available for patients at various disease stages. While most trials focus on adults, one study specifically includes children and young adults, addressing the unique needs of younger patients with challenging tumors.

Ongoing Clinical Trials on Hepatic cancer

  • Study of intra-arterial angiotensin II during radioembolization to improve treatment effectiveness in patients with primary or secondary liver cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands
  • Evaluating the use of technetium (99mTc) galactosyl serum albumin to predict complications in patients undergoing surgery for liver tumors

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Denmark
  • Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Italy Spain
  • Study of Pembrolizumab and Lenvatinib for Patients with Advanced Liver Cancer Resistant to Previous Immunotherapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany