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

Female doctor with clipboard during home visit while entering house

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.

scientist pipetting tube test in the research laboratory

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.

Selected Trials

Click the articles below to read more about each trial.

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.

Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors

This is an Open-label, Phase 1b/2 Study of the Pressure-Enabled Hepatic Artery Infusion (HAI) of SD-101, a TLR9 agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC).

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.

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)

Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).

Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma

This study is an open-label, phase 1/1b study of the pressure-enabled hepatic artery infusion of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in adults with metastatic uveal melanoma.

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.

Studying the treatment of uveal melanoma with liver metastases

The PERIO-01 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)

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)

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

ECT204 T-Cell Therapy in Adults With Advanced HCC (ARYA3)

This will be an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of ECT204 T-cell therapy and determine the RP2D in adult subjects (≥ 18 years of age) who have GPC3-positive HCC and have failed or not tolerated at least two (2) different anti-HCC systemic agents.

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

A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

This study employs a 2-stage design that aims to evaluate the efficacy and safety of ENV- 101, a potent Hedgehog (Hh) pathway inhibitor, in patients with refractory advanced solid tumors characterized by loss of function (LOF) mutations in the Patched-1 (PTCH1) gene. Stage 1 of this study will enroll approximately 44 patients randomized between two dose levels. As appropriate, Stage 2 of the study will expand enrollment based on the results of Stage 1.