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 aged 18 to 75 at the time of signing the consent form
• People with pancreatic cancer that has spread to other parts of the body (metastatic), confirmed by tissue or cell testing
• People who have at least one measurable area of cancer spread, detectable by a chest, abdomen, and pelvis scan (or MRI with an alternative scan if there is an allergy to contrast dye)
• People who received earlier treatment (including combined radiation and chemotherapy) for non-metastatic disease, provided at least 6 months passed between the end of that treatment and the cancer returning
• People who are generally well enough to carry out light activity and care for themselves (a medical fitness score of 0 or 1 on the WHO scale)
• People with a specific blood level of uracil below 16 ng/ml (confirm with trial site)
• People with blood count results within acceptable ranges, tested within 14 days before treatment starts, including sufficient white blood cells, platelets, and haemoglobin
• People with kidney and liver function within acceptable levels, tested within 14 days before treatment starts
• People with calcium, magnesium, and potassium blood levels within a specified normal range
• People who are sexually active and agree to use contraception approved by the treating doctor throughout treatment and for up to 6 months after treatment ends
• People who have signed the consent form before any study-specific procedures begin
• People who are enrolled in the French national social security system

Who may not be able to join:

• People with known cancer spread to the brain
• People who have already received radiotherapy, surgery, chemotherapy, or any experimental treatment specifically for their metastatic disease
• People who had major surgery (not including diagnostic biopsy) within 4 weeks before the first day of study treatment
• People with a condition called Gilbert's syndrome, or who carry two copies of a specific gene variant known as UGT1A1*28
• People with another active cancer or a history of cancer, with some exceptions for certain low-risk or fully treated cancers with no signs of disease in the 3 years before joining (confirm specific exceptions with trial site)
• People with high cardiovascular risk, including those who have had a coronary stent placed or a heart attack within the past 6 months
• People who already have significant nerve damage causing sensory symptoms (grade 2 or higher) at the time of joining
• People whose heart electrical activity test (ECG) shows a QTc interval above 450 ms (men) or 470 ms (women)
• People with serious uncontrolled conditions affecting the liver, kidneys, lungs, metabolism, or mental health that could interfere with safe participation
• People with a known allergy or intolerance to any of the study drugs (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or their ingredients (such as fructose)
• Women who are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test within 72 hours before joining
• People currently taking blood-thinning medications called vitamin K antagonists (such as Coumadin), though the trial notes treatment changes may be possible before joining
• People who have taken a medication called brivudine within 4 weeks before or after receiving 5-fluorouracil, due to a potentially life-threatening interaction
• People with an active, uncontrolled bacterial, viral, or fungal infection requiring ongoing treatment
• People with an active HIV infection, or known hepatitis B or C infection
• People with a history of peripheral arterial disease, chronic inflammatory bowel or rectal disease, pulmonary fibrosis, or interstitial lung disease
• People who have received a live vaccine within 10 days before joining, or who would need one within 6 months after treatment
• People who are unwilling or unable to follow the study procedures
• People who are unable to attend follow-up appointments for geographic, social, or psychological reasons
• People who have participated in another clinical trial involving an experimental treatment within the 30 days before joining
• People who are legally unable to consent for themselves, such as those under guardianship

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