Early Phase 1 Liver Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who have been diagnosed with colon cancer (confirmed by tissue testing) that has not spread to distant parts of the body (stage I, II, or III), and who are planning to have surgery to remove the tumor.
• People who have been diagnosed with colon cancer (confirmed by tissue or cell testing) that has spread to the liver in a way that can be surgically removed, and who are planning to have liver surgery.
• People who have not had any previous radiation or drug treatments for stage I, II, or III colon cancer before surgery.
• People with liver spread who have had prior treatments are still considered, as long as chemotherapy or radiation was finished at least 4 weeks before liver surgery, or at least 6 weeks before liver surgery if the treatment included a drug called bevacizumab.
• People aged 18 or older.
• People who are generally well enough to carry out light activity and care for themselves (confirm with trial site regarding the specific fitness level required).
• People whose liver, kidney, and blood chemistry results are within acceptable ranges as determined by standard lab tests (confirm with trial site for specific values).
• People who take blood-thinning medications, provided their dose is stable, their blood-clotting levels are within the target range, and they have no active or high-risk bleeding conditions — including people on anti-platelet medications or daily low-dose aspirin for heart conditions such as atrial fibrillation.
• People who are not pregnant and not breastfeeding; women who could become pregnant must have a negative pregnancy test within 14 days before joining the trial.
• Women who could become pregnant and men must agree to use reliable contraception throughout the trial period.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People with stage I, II, or III colon cancer who have already had drug treatment, radiation, or taken part in another experimental treatment before surgery.
• People who have had chemotherapy or radiation within 4 weeks before their planned liver surgery (or within 6 weeks if the treatment included bevacizumab).
• People who are currently receiving other cancer treatments, including chemotherapy, targeted therapies, immunotherapy, or other experimental treatments not covered by this trial.
• People who are unable to swallow pills.
• People who have difficulty absorbing food or medications, or who have uncontrolled vomiting, diarrhea, or any other condition that seriously affects how the digestive system works.
• People who have had an allergic reaction to compounds that are chemically similar to vitamin D.
• People who have regularly taken vitamin D supplements totalling 2,000 IU or more per day over the past year.
• People who take certain long-term medications that can lower vitamin D levels, including oral corticosteroids (short-term use as an anti-nausea medication during chemotherapy is allowed), lithium, phenytoin, quinidine, isoniazid, or rifampin.
• People who regularly take a type of blood pressure medication called thiazide diuretics (such as hydrochlorothiazide) and who are unwilling or unable to stop taking them or switch to a different medication, as this type of drug can raise calcium levels in the blood.
• People who already have higher-than-normal calcium levels in their blood; the use of calcium supplements is also not allowed during the trial.
• People who have a known overactive parathyroid condition or another serious calcium metabolism disorder diagnosed within the past 5 years.
• People who have had kidney or urinary tract stones causing symptoms within the past year.
• People with any serious uncontrolled illness, such as an active infection, unstable heart condition, uncontrolled heart rhythm problems, or a mental health condition that the trial team believes could increase health risks, affect the ability to follow the study requirements, or make it harder to interpret the results.
• Women who are pregnant or breastfeeding, or men and women who could have children and are not willing to use reliable contraception.
• People with a history of another cancer, except those whose previous cancer was treated with the intent to cure, has shown no signs of returning for more than 3 years before joining the trial, and is considered low risk for coming back — or people who have had certain treated skin cancers, cervical cancer in situ, or a non-cancerous prostate condition with no evidence of prostate cancer.
• People who have tested positive for HIV, hepatitis C, or active or chronic hepatitis B.

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