Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have cancer that has spread (metastasized) to the lung, liver, or soft tissue from any original cancer type, and it cannot be cured with local treatments alone.
• You may have had one previous treatment with a type of immunotherapy called anti-PD-1/L1 therapy.
• You have at least 2 tumors that can be measured and tracked over time during the study.
• Your tumors are located in a way that allows a needle injection (guided by imaging such as CT or MRI) directly into up to two lung or liver tumors.
• Your tumors are suitable to receive radiation therapy, as confirmed by your doctor.
• You are 18 years of age or older.
• You are reasonably active and able to care for yourself (confirm with trial site for exact definition).
• Your blood counts, kidney function, and liver function meet specific minimum levels shown in routine blood tests (confirm with trial site for exact values).
• If your lung tumors are being treated, your lungs must be functioning at an adequate level based on a breathing test done within 30 days before the injection (not required if only liver tumors are being treated).
• If you need supplemental oxygen due to a tumor blocking your airway, you may still be eligible if the oxygen need has been stable and recently started (confirm with trial site).
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before the injection and agree to use reliable contraception throughout the study and for about 5 and a half months after the last immunotherapy dose.
• You are willing and able to sign a consent form showing you understand and agree to take part in the study.

Who may not be able to join:

• You have previously had radiation therapy to the specific tumor(s) chosen for high-dose treatment in this trial.
• You currently have active, symptomatic cancer that has spread to the brain or the lining of the brain, unless those brain tumors were previously treated, have been stable for at least 4 weeks, and you have not needed steroid medication for at least 14 days.
• You have a history of certain serious lung conditions, such as interstitial lung disease or unresolved lung inflammation (confirm with trial site for full list).
• You have had a severe (Grade 4) reaction to radiation therapy in the past.
• You have unresolved serious bleeding or inflammation in the lungs or abdomen related to past radiation or immunotherapy.
• You have unresolved serious bowel or abdominal problems, such as colitis, bowel blockage, or known risk factors for bowel perforation.
• You previously had a severe (Grade 3 or higher) immune-related side effect from immunotherapy, or a known severe allergic reaction to ingredients in the study drug.
• You have received any other cancer treatment or immunotherapy (other than anti-PD-1/L1) within 2 weeks before the injection.
• You have an active autoimmune disease that required systemic medical treatment within the past 2 years (simple hormone replacement therapy is generally not considered systemic treatment — confirm with trial site).
• You received a live-virus vaccine within 4 weeks before the injection (killed-virus flu vaccines are generally allowed; other vaccines may be considered on a case-by-case basis).
• You have previously had a stem cell transplant from a donor or an organ transplant.
• You have an uncontrolled serious illness, such as an active infection, heart failure, unstable chest pain, kidney failure, irregular heartbeat, or a mental health condition that could affect your ability to follow the treatment plan.
• You have an active, uncontrolled HIV, hepatitis B, or hepatitis C infection.
• You are currently pregnant or breastfeeding.
• You are a woman who could become pregnant, or a male participant (or male partner of a woman who could become pregnant), and you are unwilling or unable to use effective birth control during the study and for several months after the last immunotherapy dose.
• Your doctor feels that participating in this trial would not be in your best interest for any reason.

Important: Always verify eligibility with the trial site directly before applying.