Phase 1 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 are willing and able to sign a consent form and follow all study requirements for the full duration of the trial.
• People aged 18 years or older.
• People who have been diagnosed with pancreatic adenocarcinoma (a specific type of pancreatic cancer), confirmed by laboratory testing of tissue or cell samples, that has spread to the lining of the abdominal cavity (peritoneum) but not to any other organs.
• People whose primary pancreatic tumour is classified as removable by surgery, borderline removable, or locally advanced, according to standard medical guidelines (NCCN classification).
• People with a peritoneal cancer index (PCI) score of 8 or below — a measure of how much cancer is present in the abdominal cavity (confirm with trial site).
• People with a general health and activity level rated at 0 or 1 on a standard medical scale (ECOG), meaning they are fully active or have only minor limitations in physical activity.
• People who have received between zero and four months of treatment with a chemotherapy regimen called FOLFIRINOX, modified FOLFIRINOX, or NALIRIFOX, and who the treating doctor considers able to continue receiving further treatment.
• People whose blood test results meet minimum required levels for white blood cells, platelets, and haemoglobin, without having needed certain blood-stimulating medications in the two weeks before screening.
• People whose liver function blood tests are within acceptable ranges (with allowance for a drainage procedure if there is a bile duct blockage).
• People whose kidney function blood test results are within acceptable ranges.

Who may not be able to join:

• People who have previously had surgery or participated in an experimental treatment trial for pancreatic cancer that had spread to distant parts of the body (note: certain procedures such as bile duct drainage, diagnostic keyhole surgery, or bowel stenting are permitted).
• People whose cancer has visibly spread to areas of the body outside the abdominal lining.
• People with a PCI score above 8, indicating more extensive spread within the abdominal cavity.
• People whose cancer is known to have continued growing or worsening during any previous chemotherapy treatment.
• People with a known allergy or sensitivity to paclitaxel (the study drug) or to other liposomal (fat-based) drug products.
• People currently taking certain medications that strongly interact with paclitaxel through a specific liver enzyme pathway (CYP2C8), or who have other medical reasons that would make paclitaxel unsafe for them.
• People known to have specific genetic enzyme deficiencies (UGT1A1 or DPD) that affect how certain chemotherapy drugs are processed in the body.
• People experiencing nerve damage or nerve-related symptoms rated at Grade 2 or higher on a standard medical scale (confirm with trial site).
• People with a known active COVID-19 infection with symptoms at the time of enrolment.
• People who have ever received, or are currently receiving, radiation therapy for pancreatic cancer.
• People who have received a live or attenuated (weakened) vaccine within the 30 days before the first dose of the study treatment.
• People who have tested positive for HIV, or who have active or chronic hepatitis B or C — although people with a history of hepatitis B or C whose virus levels are undetectable after antiviral treatment may still be considered.
• People who have an active infection at the time of screening or on the day treatment is due to begin, which the treating doctor believes could affect their safety or the study results.
• People with any other medical or personal circumstances that the treating doctor believes would prevent them from safely participating in or completing the study.
• People who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants who are capable of reproduction must agree to use highly effective contraception throughout the study and for 9 months after the last dose of study treatment.
• People diagnosed with a type of pancreatic cancer other than adenocarcinoma, such as neuroendocrine tumours or acinar cell carcinoma.
• People whose treating doctor considers their cancer to be deteriorating to a clinically unacceptable degree at the time of screening.

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