Active Clinical Trials

Clinical trials are research studies that involve people. Any time you or a loved one need treatment for cancer, clinical trials are an option to think about. Learning all you can about clinical trials can help you talk with your doctor and decide what is right for you.

Through clinical trials, new treatments and ways to improve liver cancer care are moved forward. Clinical trials also determine if treatments are safe and effective in the treatment of liver cancer.

Clinical trials evaluate:

  • New diagnostic methods
  • New drugs and medicines
  • New combinations of treatments
  • New approaches to surgery or radiation
Clinical trials are highly controlled and regulated. They can be sponsored by the federal government, medical institutions, pharmaceutical companies, and private foundations.
ClinicalTrials.gov, which is part of the National Library of Medicine, lists clinical trials for cancer and many other diseases and conditions. It contains trials that are in the National Cancer Institute’s (NCI) list of cancer trials as well as trials sponsored by pharmaceutical or biotech companies that may not be on NCI’s list.

If you are thinking about joining a clinical trial as a treatment option, the best place to start is to talk with your doctor or another member of your health care team. Often, your doctor may know about a clinical trial that could be a good option for you. He or she may also be able to search for a trial for you, provide information, and answer questions to help you decide about joining a clinical trial. Some doctors may not be aware of or recommend clinical trials that could be appropriate for you. If so, you may want to get a second opinion about your treatment options, including taking part in a clinical trial.

There are many lists of cancer clinical trials taking place in the United States. Some trials are funded by nonprofit organizations, including the U.S. government. Others are funded by for-profit groups, such as drug companies. Hospitals and academic medical centers also sponsor trials conducted by their own researchers. Because of the many types of sponsors, no single list contains every clinical trial.

Treating liver tumors can be a challenge for physicians given the location of tumors in the liver and the unique microenvironment and immunology of the liver. The liver is difficult to access which makes it difficult to effectively deliver anti-cancer treatment and liver tumors can shut down anti-tumor immunotherapy drugs.
To search for a specific cancer clinical trial, visit www.cancer.gov or call NCI’s Cancer Information Service that can provide a tailored clinical trials search that you can discuss with your doctor. To reach them call 1-800-4-CANCER (1-800-422-6237) and select option 2. This is a free service.

If you decide to look for a clinical trial, you will need to know certain details about your cancer diagnosis and compare these details with the eligibility criteria of any trial that interests you. Eligibility criteria are the requirements that must be met for you to join a clinical trial.

The Liver Central resource showcases trials across the landscape for treatment of cancer in the liver. Cancer in the liver can be primary, such as hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA) or secondary cancer that has spread from a different organ.

Check out information about ongoing clinical research from Liver Central’s founding sponsor TriSalus here.

The National Institutes of Health identify more than 3,000 clinical trials for “liver cancer.” There are many trials underway to identify new treatments for cancer in the liver. Talk with your doctor or treatment team about identifying a trial that may be appropriate to treat the cancer in your liver.

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Selected Trials

Click the articles below to read more about each trial.

A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma

This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.

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A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma

To find out if adding pembrolizumab to standard of care chemotherapy drugs (cisplatin and gemcitabine) will improve long-term response of intrahepatic cholangiocarcinoma after surgery, compared to treatment with surgery and standard chemotherapy alone.

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A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis (Kirros)

This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 liver cirrhosis and have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety and efficacy of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.

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Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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TheraSphere With Durvalumab and Tremelimumab for HCC (ROWAN)

The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab. It is a global open-label, prospective, multi-center Phase II trial designed to assess the safety and efficacy of TheraSphere administered before initiation of Durvalumab with Tremelimumab in HCC patients who are not a candidate for resection, thermal ablation or liver transplant at the time of study entry.

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Y-90 With Durvalumab/​Gem/​Cis in Intrahepatic Cholangio

This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery.

The specific names of the interventions that will be used are:

Y-90 (a type of radiation microsphere bead)

Durvalumab (a type of immunotherapy)

Gemcitabine (a type of chemotherapy)

Cisplatin (a type of chemotherapy)

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Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutation Cholangiocarcinoma

This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy

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Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer

This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in treating patients with liver cancer that cannot be removed  by surgery after undergoing standard high-dose external beam radiotherapy.  Autologous dendritic cells are immune cells generated from patients’ own white  blood cells that are grown in a special lab and trained to stimulate the immune  system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help  stimulate the immune system. Giving autologous dendritic cells and Prevnar to patients with liver cancer after radiotherapy may help doctors determine if it is  possible to stimulate the body’s own immune system to fight against the tumor, and to see if this immune stimulation can be done safely. 

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Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (DOORwaY90)

The investigation is a pivotal, prospective, multicenter, open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.Up to 100 subjects will be treated (up to 150 consented) at up to 30 clinical sites in the United States.The population for this study includes patients diagnosed with HCC BCLC stage A, B1, B2, and C with maximal single lesion size of ≤ 8cm and who are not considered suitable for treatment by resection or eligible for ablation at time of study entry.

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Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT

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Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria

During the study, patients will receive transarterial chemoembolization (TACE) every 3 months, with a maximum of 4 treatments, plus atezolizumab combined with bevacizumab. The combination of atezolizumab with bevacizumab is expected to down-grade the tumor size and potentially allow patients to reach the smaller tumor criteria of MC for qualifying for exception points for a liver transplant.

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Futibatinib and Pembrolizumab for the Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer

This phase II trial studies the effect of futibatinib and pembrolizumab in treating patients with FGF19 positive BCLC stage A, B, or C liver cancer that has spread to other parts of the body (advanced or metastatic). Futibatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving futibatinib and pembrolizumab may help treat patients with FGF19 positive liver cancer.

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A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152) (SKYSCRAPER-14)

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).

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ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (ARYA-2)

Open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety/tolerability and determine the recommended Phase II Dose (RP2D) of ET140203 T-cells in pediatric subjects who are AFP-positive/HLA-A2-positive and have relapsed/refractory HB, HCN-NOS, or HCC.

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An Open-Label, Dose Escalation, Multi-Center Phase I/II Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-3)

The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ECT204 T cells are autologous T cells genetically modified to carry a construct capable of mediating cell killing by targeting tumor specific antigens.

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High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies

This study prospectively evaluates the clinical effectiveness of the use of high dose rate brachytherapy (HDRBT) for the treatment of both primary and secondary unresectable liver malignancies assessed by comparing local tumor control (LTC) rates at 6 months with a historical cohort.

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Studying the treatment of hepatocellular carcinoma and intrahepatic cholangiocarcinoma

The PERIO-02 clinical trial is studying the ability of SD-101 using the PEDD method of administration to overcome two major challenges of treatment:

  • immunosuppression
  • high intratumoral pressure (ITP)

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Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer

This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in treating patients with liver cancer that cannot be removed by surgery after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients’ own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Giving autologous dendritic cells and Prevnar to patients with liver cancer after radiotherapy may help doctors determine if it is possible to stimulate the body’s own immune system to fight against the tumor, and to see if this immune stimulation can be done safely.

Read More

Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC (EMERALD-3)

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

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A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.

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