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 between 18 and 75 years old at the time of signing the consent form.
• People whose pancreatic cancer has been confirmed through a tissue or cell sample (biopsy or similar test).
• People who are largely able to carry out daily activities with little or no limitation (as measured by a standard medical scale called ECOG, with a score of 0 or 1).
• People whose tumour cannot be surgically removed, as confirmed by a panel of specialist experts reviewing scan images using recognised guidelines.
• People whose cancer has not spread to other parts of the body, confirmed by CT scans of the chest, abdomen and pelvis, and an MRI of the liver.
• People whose scans show that a specific type of radiation treatment used in this trial (called SMART) is technically possible, as confirmed by a central review team.
• People with a blood level of a substance called uracil below 16 ng/ml (a measure related to how the body processes certain chemotherapy drugs).
• People whose recent blood test results (within the past 14 days) show adequate levels of white blood cells, platelets, and red blood cells.
• People whose recent liver function blood tests (within the past 14 days) fall within acceptable ranges. People with a metal stent placed in the bile duct due to the cancer may still be considered if certain specific conditions are met (confirm with trial site).
• People whose kidney function tests are within normal range, or show adequate kidney function using a specific calculation method.
• People whose blood levels of calcium, magnesium, and potassium fall within an acceptable range.
• People with a tumour marker in the blood called CA 19.9 below 500 IU/mL. People with levels between 500 and 1,000 IU/mL may still be considered if further scans show no signs of spread. People with levels at or above 1,000 IU/mL are not eligible.
• People who are sexually active and willing to use an effective method of contraception throughout the treatment period and for up to 6 months after treatment ends (for both males and females).
• People who have signed the consent form before any trial-related procedures begin.
• People who are covered by French national health insurance.

Who may not be able to join:

• People who have already received any treatment for pancreatic cancer, such as chemotherapy, radiotherapy, surgery, targeted therapy, or experimental treatments.
• People with a genetic condition called Gilbert's syndrome or a specific inherited variation in a gene called UGT1A1 (homozygous UGT1A1*28) that affects how the body breaks down certain drugs.
• People with another active cancer, or a history of cancer, with some exceptions for certain low-risk or fully treated cancers (confirm with trial site for specific details).
• People who have previously had radiotherapy in an area of the body that would overlap with the radiation area planned for this trial.
• People with significant heart or cardiovascular conditions, including a coronary stent or heart attack within the past 6 months.
• People who have nerve damage in their hands or feet (peripheral neuropathy) that is moderate or severe.
• People whose heart electrical activity test (ECG) shows a specific measurement (QT interval) that is too long — above 450 milliseconds for men or 470 milliseconds for women.
• People for whom MRI scans or MRI-guided radiotherapy are not medically safe or suitable.
• People with a history of long-term inflammatory bowel disease affecting the colon or rectum.
• People with another serious, uncontrolled illness that could affect their safety or ability to participate in the trial.
• People who have a known allergy or intolerance to any of the study drugs (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, or 5-FU) or their ingredients.
• People who are legally unable to consent for themselves (for example, those under legal guardianship).
• Women who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy blood test within 72 hours before joining.
• People currently taking blood-thinning medications called vitamin K antagonists (such as warfarin/Coumadin), though a change in medication before joining may be possible (confirm with trial site).
• People with an active, uncontrolled bacterial or fungal infection requiring treatment.
• People with a known active HIV infection.
• People with a history of disease affecting the arteries in the arms or legs (peripheral arterial disease), such as pain when walking or Buerger's disease.
• People who have received a live vaccine within the 10 days before joining the trial.
• People with a history of lung scarring conditions such as pulmonary fibrosis or interstitial pneumonia.
• People who would be unable to attend follow-up visits due to geographic, social, or mental health reasons.
• People who have participated in another clinical trial involving an investigational treatment within the past 30 days.

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