Testing immunotherapy with or without stereotactic body radiation therapy in patients with advanced liver cancer

People who have advanced primary liver cancer may be eligible for the study.

This study is being done to answer the following question: Will stereotactic body radiation therapy (SBRT) to the liver combined with immunotherapy extend your life longer than immunotherapy alone? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your liver cancer. The usual approach is defined as care most people get for liver cancer.

If you decide to take part in this study, you will either get immunotherapy-based drug treatment until your disease gets worse or the side effects become too severe, or you will get liver stereotactic body radiation therapy (SBRT) for up to 3 weeks plus immunotherapy-based drug treatment until your disease gets worse or the side effects become too severe.

The usual approach for patients who are not in a study, particularly among patients with disease spread beyond the liver, is treatment with immunotherapy-based drug treatment. There are three usual immunotherapy-based drug treatment combinations: atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. For patients who get the usual approach for this cancer, about 40 out of 100 patients are alive at 2 years.

If you choose to take part in this study, there is a risk that the study approach may not be as good as the usual approach for shrinking or stabilizing your cancer. There is also a risk that you could have side effects from the study radiation therapy. These side effects may be worse and may be different than you would get with the usual approach for your cancer. Your doctor will review all of the potential side effects with you. There may be some risks that the study doctors do not yet know about.

The main possible benefit of this study for the participants is that the combination of SBRT and immunotherapy might be better than immunotherapy alone. It is not possible to know now if the study approach will extend your life longer compared to the usual approach. This study will help the study doctors learn things that will help people in the future.

After you finish your study treatment, your doctor will continue to follow your condition and watch you for side effects. They will check you every 3 months after you finish treatment for 2 years, then every 6 months for 3 years, then once every year for your lifetime.

No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, your doctor will discuss other treatment options with you.

You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer.

This includes:

• The costs of tests, exams, procedures, and drugs that you get during the study to monitor your safety, and prevent and treat side effects.  
• The costs of getting the immunotherapy drugs ready and giving it to you. 
• The costs of the stereotactic body radiation therapy (SBRT). 
• Your insurance co-pays and deductibles. 

Talk to your insurance provider and make sure that you understand what your insurance pays for and what it doesn’t pay for if you take part in this clinical trial. Also, find out if you need approval from your plan before you can take part in the study. 

You will not be paid for taking part in this study.

Your privacy is very important to us. The study doctors will make every effort to protect it. The study doctors have a privacy permit to help protect your records if there is a court case. However, some of your medical information may be given out if required by law. If this should happen, the study doctors will do their best to make sure that any information that goes out to others will not identify who you are. Some of your health information, such as your response to cancer treatment, results of study tests, and medicines you took, will be kept by the study sponsor in a central research database. However, your name and contact information will not be put in the database. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

There are organizations that may look at or receive copies of some of the information in your study records. Your health information in the research database also may be shared with these organizations. They must keep your information private, unless required by law to give it to another group. Some of these organizations are:

• NRG Oncology and any company supporting the study now or in the future. 
• The National Cancer Institute (NCI Central Investigational Review Board (IRB), which is a group of people who review the research with the goal of protecting the people who take part in the study. 
• The Food & Drug Administration (FDA) and the groups it works with to review research. 
• The NCI and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU). 
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research Imaging and Radiation Oncology Core (IROC).  
• VisionTree, Inc. (if you consent to completing questionnaires electronically your responses to questionnaires will be collected).

Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.

Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

physician offices

hospitals

clinics

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials".

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer