Ongoing Clinical Trials for Metastases to Liver
This article provides detailed information about 6 ongoing clinical trials investigating new treatments for metastases to the liver. These trials are taking place across Europe, including the Netherlands, Sweden, Germany, and Norway, and are testing various treatment approaches including fluorescence-guided surgery, immunotherapy combinations, and specialized chemotherapy delivery methods. Patients interested in participating should review the specific eligibility criteria for each trial.
Clinical trial locations
- Germany
- Netherlands
- Study on Fluorescence-Guided Surgery for Colorectal Liver Metastases Using SGM-101 and Indocyanine Green for Patients with Colorectal Cancer
- Study on Recurrent Colorectal Liver Metastases: Evaluating Calcium Folinate, Fluorouracil, Capecitabine, Oxaliplatin, and Irinotecan in a Drug Combination for Eligible Patients
- Study on the Effectiveness of Floxuridine and Drug Combination for Patients with Unresectable Colorectal Liver Metastases
- Norway
- Sweden
Study on Fluorescence-Guided Surgery for Colorectal Liver Metastases Using SGM-101 and Indocyanine Green for Patients with Colorectal Cancer
This trial, being conducted in the Netherlands, is exploring an innovative surgical approach for patients with colorectal cancer that has spread to the liver. The study uses special imaging substances that make cancerous tissue glow during surgery, helping surgeons identify and remove tumors more effectively.
Main inclusion criteria: Patients must be diagnosed with liver metastases originating from colorectal cancer and have surgery planned. They need to meet at least one of these conditions: be scheduled for removal of more than 3 metastases, have completed treatment within 3 months before surgery, or have a recurring metastasis in the same area. Participants must be at least 18 years old and able to provide informed consent.
Main exclusion criteria: Patients cannot participate if they have other serious medical conditions, are pregnant or breastfeeding, have participated in another recent trial, have known allergies to the imaging substances used (ICG or SGM-101), or cannot provide informed consent. Those with a history of severe allergic reactions to similar substances are also excluded.
Focus and goal: The trial aims to determine whether using both SGM-101 and Indocyanine Green together can improve how doctors identify and remove liver metastases during surgery. The substances are injected before surgery and make cancer cells glow under special lighting, potentially leading to more complete tumor removal and better patient outcomes.
Investigational treatments: SGM-101 is a specialized protein that attaches to cancer cells and makes them fluoresce under special lighting. Indocyanine Green is a dye that helps highlight blood vessels and tissues, making it easier to visualize areas requiring surgical attention. Both are administered through injection before the surgical procedure.
Study on Melphalan, Ipilimumab, and Nivolumab for Patients with Uveal Melanoma Liver Metastases
This Swedish trial focuses on a specific type of eye cancer called uveal melanoma that has spread to the liver. The study compares two treatment approaches: combining a specialized liver-directed chemotherapy procedure with immunotherapy drugs versus using immunotherapy alone.
Main inclusion criteria: Patients must be at least 18 years old with confirmed liver metastasis from uveal melanoma. They must have an ECOG performance status of 0 or 1, meaning they can perform daily activities with little to no restriction. The disease must be measurable in the liver by CT scan. Patients should not have received previous treatment for metastases, except in cases of disease progression after specific treatments. Both men and women of childbearing potential must agree to use reliable birth control methods.
Main exclusion criteria: Patients with cancers other than uveal melanoma liver metastases cannot participate. Those outside the specified age range, belonging to vulnerable populations, or deemed ineligible for the treatment groups by study doctors are excluded.
Focus and goal: The trial evaluates whether adding Percutaneous Hepatic Perfusion (PHP), which delivers high-dose chemotherapy directly to the liver, can improve outcomes when combined with the immunotherapy drugs Ipilimumab and Nivolumab. The study will monitor disease progression, overall health, and quality of life over several years to provide comprehensive data on treatment effectiveness and safety.
Investigational treatments: Ipilimumab and Nivolumab are immunotherapy medications that help the immune system fight cancer cells. PHP is a specialized procedure that delivers concentrated chemotherapy to the liver while protecting the rest of the body from the drug’s effects.
Study on Preoperative Immunotherapy with Atezolizumab and Tiragolumab for Patients with Colorectal Liver Metastases
This German trial is testing whether giving immunotherapy treatment before surgery can help shrink tumors in patients with colorectal cancer that has spread to the liver. The study uses two medications that boost the immune system’s ability to fight cancer.
Main inclusion criteria: Patients must be 18 years or older with confirmed colorectal adenocarcinoma that has spread to the liver and can be surgically removed with curative intent. The metastases must be accessible for biopsy, and the disease must be microsatellite stable (MSS) or proficient mismatch repair (pMMR). Patients should have no disease outside the liver except for local lymph node metastases. They must have an ECOG Performance Status of 0 to 1 and adequate blood, liver, and kidney function. Both men and women must agree to use effective birth control during the study.
Main exclusion criteria: Patients with other types of cancer, those outside the specified age range, or those belonging to vulnerable populations cannot participate. Patients must be able to undergo routine medical procedures including tumor removal and examination.
Focus and goal: The trial aims to determine if the combination of Atezolizumab and Tiragolumab given before surgery can reduce tumor size, making surgery more successful and improving patient outcomes. The study will use imaging scans like PET-CT or PET-MRI to assess how well the cancer responds to treatment.
Investigational treatments: Atezolizumab (Tecentriq) is an immunotherapy that helps the immune system recognize and attack cancer cells by blocking a protein called PD-L1. Tiragolumab is another immunotherapy drug that enhances the immune response by targeting the TIGIT protein. Both are administered through intravenous infusion.
Study on the Effectiveness of Floxuridine and Drug Combination for Patients with Unresectable Colorectal Liver Metastases
This Dutch trial compares two treatment strategies for patients whose liver metastases cannot initially be removed by surgery. The study tests whether combining a specialized liver-directed chemotherapy pump with standard systemic therapy works better than systemic therapy alone.
Main inclusion criteria: Patients must be at least 18 years old with confirmed colorectal adenocarcinoma that has spread to the liver in a way that cannot be surgically removed, as confirmed by a medical panel using CT scan. The primary tumor must be in place and removable by surgery. Patients must be eligible for surgery and dual-drug chemotherapy. No previous systemic treatment for colorectal cancer is allowed. Patients must have adequate blood cell counts, liver and kidney function, and an ECOG performance status of 0 or 1. Life expectancy must be at least 12 weeks.
Main exclusion criteria: Patients who have received previous chemotherapy for liver metastases, those with other serious health conditions that could interfere with the study, pregnant or breastfeeding women, those unable to follow study procedures, those with allergies to study drugs, or those with certain infections cannot participate.
Focus and goal: The trial aims to determine if adding Hepatic Arterial Infusion Pump (HAIP) chemotherapy to systemic therapy can improve survival in patients with initially unresectable liver metastases. The study will monitor various outcomes including overall survival, progression-free survival, and the rate at which cancer becomes surgically removable after treatment.
Investigational treatments: HAIP chemotherapy delivers drugs directly into the liver through a pump, potentially increasing drug concentration in the liver while reducing exposure to the rest of the body. The systemic therapy includes medications such as irinotecan, oxaliplatin, capecitabine, fluorouracil, calcium folinate, bevacizumab, and dexamethasone acetate, with floxuridine used in the HAIP group.
Study on Recurrent Colorectal Liver Metastases: Evaluating Calcium Folinate, Fluorouracil, Capecitabine, Oxaliplatin, and Irinotecan in a Drug Combination for Eligible Patients
This Netherlands-based trial focuses on patients whose colorectal liver metastases have returned after initial treatment. The study explores whether giving systemic therapy before repeating local treatments can improve outcomes compared to local treatment alone.
Main inclusion criteria: Patients must have tissue confirmation of their primary colorectal tumor and a life expectancy of at least 12 weeks. They must have received local treatment for initial liver metastases and now have at least one recurrent metastasis that can be treated locally, with a maximum of 5 total metastases. Patients must be older than 18 years with an ECOG performance status of 0-2 and ASA grade of 1-3. Adequate bone marrow, liver, and kidney function is required, as demonstrated by specific blood tests within 7 days before screening.
Main exclusion criteria: Patients with other types of cancer not related to the liver or colon, those who had a different cancer in the past 5 years (except non-melanoma skin cancer), those with serious heart problems, uncontrolled high blood pressure, severe untreated infections, pregnant or breastfeeding women, those with known allergies to study medication, those participating in another trial simultaneously, or those with a history of drug or alcohol abuse in the past 2 years cannot participate.
Focus and goal: The trial compares the overall survival of patients receiving repeat local treatments with or without neoadjuvant systemic therapy. Neoadjuvant therapy is treatment given before the main procedure to help shrink tumors or slow their growth, potentially making local treatment more effective.
Investigational treatments: The neoadjuvant systemic therapy involves a combination of calcium folinate, fluorouracil, capecitabine, oxaliplatin, and irinotecan. These medications are administered through different routes: some intravenously, some orally, depending on the specific drug. The treatment aims to target cancer cells throughout the body before local procedures.
Study on Treatment for Colorectal Liver Metastases Using Heparin, Dexamethasone, and Floxuridine for Patients with Heavy Tumor Burden
This Norwegian trial is investigating treatments for patients with a significant amount of cancer spread to the liver from colorectal cancer. The study uses a combination of medications including a blood thinner, steroids, and chemotherapy to evaluate their effectiveness in improving long-term survival.
Main inclusion criteria: Patients must have confirmed adenocarcinoma of the colon or rectum that has spread to the liver. They must meet specific criteria regarding tumor burden: the liver tumors cannot be surgically removed at the time of joining, surgery would require significant tumor shrinkage, they need new chemotherapy due to treatment failure or side effects, or they have stable/partially reduced tumor size but are unlikely candidates for surgery due to extensive liver involvement. Patients must have received at least one prior chemotherapy and be planned for another. They must have good overall health with a performance status of 0 or 1 and satisfactory blood test results. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
Main exclusion criteria: Patients with medical conditions other than colorectal liver metastases, those outside the specified age range, and those belonging to vulnerable populations cannot participate.
Focus and goal: The trial evaluates the effectiveness of an extended criteria treatment approach in improving overall survival over two years for patients with heavy tumor burden. Some participants may receive a placebo to help researchers understand the true effects of the treatments being tested. The study will monitor cancer control, quality of life, and various health outcomes.
Investigational treatments: The treatment involves heparin (a blood thinner), dexamethasone acetate and dexamethasone sodium phosphate (steroids), and floxuridine (a chemotherapy drug). These medications are administered through intravenous infusion. The study also mentions the use of bevacizumab, a monoclonal antibody that blocks blood vessel formation in tumors.
Summary
These 6 ongoing clinical trials represent diverse approaches to treating liver metastases, with most focusing on colorectal cancer spread to the liver and one addressing uveal melanoma metastases. Geographically, the Netherlands hosts the most trials with three studies, followed by single trials in Sweden, Germany, and Norway, indicating strong Northern European involvement in this research area.
The trials explore several innovative treatment strategies including fluorescence-guided surgery for more precise tumor removal, various immunotherapy combinations to enhance the immune system’s cancer-fighting ability, and specialized chemotherapy delivery methods such as hepatic arterial infusion pumps that target the liver directly while minimizing systemic exposure. Several studies focus on neoadjuvant approaches, where treatment is given before surgery to improve outcomes.
Common eligibility criteria across trials include adequate organ function, particularly liver and kidney function, good performance status (typically ECOG 0-1), and requirements for effective contraception during the study period. Most trials exclude pregnant or breastfeeding women, patients with other serious medical conditions, and those unable to provide informed consent. The trials vary in their focus on initial versus recurrent metastases and on resectable versus unresectable disease, providing options for patients at different stages of their condition.
These studies aim to improve survival rates, increase surgical resection rates, enhance quality of life, and establish more effective treatment protocols for patients facing this challenging condition. Patients interested in participating should discuss these options with their healthcare providers to determine which trial might be most appropriate for their specific situation.
