Phase 2 Pancreatic 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:

• People who have signed and dated a consent form agreeing to take part.
• Adults aged 18 or older at the time of giving consent, of any sex.
• People who have had surgery to remove a pancreatic or bile duct tumour, where the tumour was classified as stage II or III before or at the time of surgery, with no or only microscopic amounts of tumour left behind (R0 or R1), and where a fluid sample taken from inside the abdomen during surgery showed no cancer cells.
• People whose cancer has been confirmed by laboratory testing as pancreatic ductal adenocarcinoma (PDA) or cholangiocarcinoma (a type of bile duct cancer).
• People who had their cancer surgery within the 12 weeks before the screening visit and are planned to receive a specific chemotherapy regimen called SLOG — whether or not they also received treatment before surgery.
• People with a good general level of physical function, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People whose blood test results at the first visit show that blood cell counts and clotting are within acceptable levels (confirm with trial site for exact values).
• People whose blood test results at the first visit show that kidney and liver function are within acceptable levels (confirm with trial site for exact values).
• People who test negative for HIV and syphilis.
• People whose blood tests show they have had a past infection with cytomegalovirus (CMV), indicated by the presence of CMV IgG antibodies.
• People who are able to become pregnant or father a child and who agree to use at least two forms of contraception (one of which must be a condom or similar barrier method) for the required periods after the last dose of the study treatment and after the last doses of the chemotherapy medicines used in the trial.
• People who agree to follow the treatment plan as set out in the trial protocol.

Who may not be able to join:

• People who have received another experimental treatment, cancer-fighting medication, or immune cell therapy within the 28 days before the screening visit.
• People with a history of any other cancer, except certain treated skin cancers (such as squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ) that were treated with freezing or surgery only, or another cancer for which a person has been considered disease-free for more than 5 years.
• People whose immune system is weakened, who are currently on medication to suppress their immune system for an autoimmune condition, or who have taken high-dose steroid medication (above a certain threshold) for more than 7 days within the 14 days before the first treatment day.
• People whose cancer has spread to other parts of the body (known metastases).
• People who have an ongoing acute illness or a serious medical condition in the past 2 years, such as severe heart problems, severe liver disease, or significant psychiatric conditions including alcohol or drug dependency, or any other condition that a doctor believes could affect the safety of taking part or the reliability of the trial results.
• People who have a condition that causes their blood to clot more easily than normal, which could lead to visible blood clots.
• People with a known allergy or sensitivity to certain antibiotics called aminoglycosides (such as streptomycin or gentamicin) or to bacitracin.
• People with a known allergy or sensitivity to any ingredient in the investigational cell therapy product (Allogeneic Magicell-NK), including human serum albumin.
• People with a known allergy or sensitivity to any of the chemotherapy medicines used in the trial (S-1, leucovorin, oxaliplatin, or gemcitabine).
• People who have any medical reason not to take S-1, leucovorin, oxaliplatin, or gemcitabine, including having severe or worsening suppression of bone marrow function.
• People who currently have active symptoms of CMV disease.
• People who have a known or suspected history of irregular heart rhythm or a heart condition involving a prolonged QT interval (a measure of heart electrical activity).
• Men whose QT interval measurement on a heart tracing (ECG) at screening is 450 ms or above, or women whose measurement is 470 ms or above.
• People who have taken any medication known to affect the QT interval of the heart within the 28 days before the screening visit (confirm with trial site for the specific list of medicines).
• People who have taken certain antiviral medicines called brivudine or sorivudine, or any live vaccines, within the 28 days before the screening visit.
• Women who are breastfeeding or who have a positive pregnancy test at screening.

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