Early Phase 1 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:

• Adults aged 18 or older who are able to give written consent to participate in the study.
• People who have been confirmed by imaging to have colon or rectal cancer that has spread (metastasized) to the liver, and where surgery to remove those liver tumors is considered possible.
• People whose cancer has spread only to the liver (not to other parts of the body), and where complete surgical removal is considered achievable (targeted ablation techniques are also allowed to help achieve this goal).
• People whose cancer has a specific tumor profile known as pMMR/MSS (meaning the cancer cells have normal DNA repair machinery), confirmed by standard laboratory testing.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale, meaning they are either fully active or able to carry out light activity (confirm with trial site).
• People who have cancer found in both the colon or rectum and the liver at the same time, and who are planned to have both areas surgically treated.
• People with rectal cancer who have received a full course of pre-surgery treatment combining chemotherapy and radiation (known as total neoadjuvant therapy) are also eligible.
• People who previously received a specific type of chemotherapy (oxaliplatin-based) after their original tumor was removed, provided at least 6 months have passed since that treatment ended.
• People who have already completed standard pre-surgery chemotherapy regimens (FOLFOX, FOLFIRI, or FOLFIRINOX) as part of their planned treatment before surgery.
• People whose liver tumors meet all surgical removal criteria: the entire tumor can be removed with clear margins, at least two connected sections of the liver can be preserved with functioning blood supply and bile drainage, and enough healthy liver will remain after surgery (at least 20% in a healthy liver, or at least 30% if the liver has been affected by chemotherapy).
• People with blood cell counts and organ function within acceptable ranges, including adequate white blood cells, platelets, and red blood cells, as well as normal-range liver and kidney function tests (confirm specific values with trial site).
• People with a life expectancy of more than 6 months.
• Women who could become pregnant must be willing to use effective contraception during treatment and for at least 9 months after the last dose of the study drug. People whose partners could become pregnant must use effective contraception during treatment and for at least 6 months after the last dose.

Who may not be able to join:

• People who have received immune-suppressing medications within the past 7 days, or any experimental drug within the past 28 days before starting the trial.
• People who have previously been treated with immune checkpoint inhibitor drugs or similar immune-modifying cancer therapies for their metastatic colorectal cancer.
• People who have had an organ transplant or a stem cell transplant from a donor.
• People with an active autoimmune disease (such as rheumatoid arthritis) that the treating doctor believes could worsen with immune-stimulating treatment.
• People with a known history of severe allergic reactions to monoclonal antibody medications.
• People who have not recovered from side effects of previous cancer treatment (excluding nerve damage or immune-related side effects) to an acceptable level.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period up to the final treatment visit.
• People who are unable to have a specific type of catheter (TriNav PEDD) placed into a blood vessel for any reason (confirm with trial site).
• People who have experienced a blood clot or stroke event (including mini-strokes, deep vein clots, or lung clots) within the 6 months before starting the study, except for adequately treated catheter-related clots that occurred more than 1 month before the start of treatment.
• People with moderate to severe heart failure (rated Class 2 or higher on the standard heart failure scale).
• People with chest pain at rest, newly developed chest pain (within the last 3 months), or a heart attack within the past 6 months.
• People with uncontrolled irregular heart rhythms.
• People with blood pressure that remains consistently above 150/90 mmHg despite best available medication management.
• People who have had a major surgery or serious injury within 28 days before starting the study treatment, or who have not fully recovered from a prior surgery.
• People with wounds, ulcers, or bone fractures that are not healing.
• People with a history or current evidence of a bleeding disorder of any severity.
• People who have had a significant bleeding event within 28 days before starting the study.
• People with serious ongoing gut problems involving significant diarrhea, such as Crohn's disease or malabsorption conditions, or moderate-to-severe diarrhea from any cause.
• People with an active autoimmune disease (note: people with Type 1 diabetes, thyroid conditions managed only with hormone replacement, or certain skin conditions not requiring systemic treatment may still be eligible — confirm with trial site).
• People currently taking high-dose steroid tablets or other immune-suppressing medications (above a specified threshold) within 14 days before starting treatment (inhaled or topical steroids at lower doses may be acceptable — confirm with trial site).
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have lung inflammation or scarring.
• People with an active infection of moderate or greater severity requiring systemic treatment.
• People with a known positive test for HIV or AIDS.
• People with a known active hepatitis B or hepatitis C infection confirmed by specific blood tests.
• Women who are pregnant or currently breastfeeding.
• People who have received a live vaccine within 30 days before the planned start of the study drugs (standard flu vaccines without live virus are permitted).
• People with a known allergy or hypersensitivity to any component of the study drugs.
• People with any medical condition, ongoing therapy, or abnormal test result that the treating doctor believes could interfere with the trial results or the person's safe participation.
• People who are unable to understand or provide informed consent for any reason.
• People with any medical condition that the treating doctor believes could affect their safety or their ability to follow the study requirements.

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