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 been diagnosed with stage IV pancreatic cancer (adenocarcinoma type) confirmed by a tissue test, with cancer that has spread to other parts of the body
• People who have not yet received any treatment for their stage IV pancreatic cancer (previous treatment given before or after surgery for an earlier stage is also not allowed)
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health scale (ECOG score of 0 or 1)
• People aged 18 to 75 years old
• People whose cancer can be measured using standard imaging scans, following specific medical guidelines (RECIST v1.1)
• People who have a tumor that can be accessed for a fresh tissue sample (biopsy)
• People whose doctors expect them to survive for more than 3 months
• People who agree to use effective contraception during the trial and for at least 6 months after the last dose of treatment, and meet specific pregnancy-related conditions (see details below and confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test within 72 hours before the first dose of treatment
• Men who are sexually active with women who could become pregnant must use a condom and spermicide during the trial and for 6 months after the last dose, and must not donate sperm during this time
• People whose blood test results from within one week before joining the trial show adequate levels of blood cells, liver function, kidney function, and blood clotting (confirm specific values with trial site)
• People with a past hepatitis C infection may be eligible if the virus is no longer detectable in their blood at the time of screening
• People who have no signs of active infection and have not had a serious infection in the past 30 days
• People who are able to understand and willing to sign a consent form before any study procedures begin
• People who are enrolled in a social security scheme (this criterion applies in France — confirm with trial site)

Who may not be able to join:

• People whose pancreatic cancer is of the endocrine or acinar type (rather than adenocarcinoma)
• People who have cirrhosis or unstable liver or bile duct disease, including conditions such as fluid buildup in the abdomen, brain confusion related to liver disease, abnormal blood clotting, low albumin, swollen veins in the food pipe or stomach, or ongoing jaundice
• People who have had a major surgery or significant physical injury within 28 days before treatment starts, have wounds that have not fully healed, or are expected to need major surgery during the trial
• People who have cancer that has spread to the brain or central nervous system
• People who have received any prior treatment for pancreatic adenocarcinoma, including before or after surgery
• People who have had a known allergic reaction to any of the components of the study treatments
• People who are pregnant or breastfeeding
• People with significant heart problems, including severe coronary artery disease, a heart attack in the last 6 months, or a high risk of dangerous heart rhythm problems; or people with low potassium, magnesium, or calcium levels in their blood
• People who have had another cancer in the last 5 years, except for certain treated skin cancers or early-stage cervical cancer
• People with a history or current signs of nervous system disease, or nerve damage of grade 1 or higher (based on a standard medical scale)
• People with any significant illness that, in the doctor's opinion, would make participation unsafe (confirm with trial site)
• People with a specific enzyme deficiency (DPD deficiency) or a particular genetic variation (UGT1A1 7/7), which affects how certain chemotherapy drugs are broken down in the body
• People who have previously received a bone marrow or stem cell transplant from another person
• People who have received a tissue or solid organ transplant from another person
• People who have a condition that weakens the immune system, or who are taking high-dose steroid medication regularly (more than 10 mg of prednisone per day or equivalent)
• People who have taken high-dose steroid medication (more than 10 mg prednisone per day or equivalent) within 7 days before the first dose, or who are taking other immune-suppressing medications (note: inhaled steroids, steroid eye drops, or local injections are allowed)
• People who have received a live vaccine within 30 days before starting the study (standard COVID-19 mRNA and adenoviral vaccines are allowed as they do not contain live virus)
• People who are HIV positive or have a positive HIV blood test result
• People who have a current or recent hepatitis B infection detected through blood tests
• People who have an active autoimmune disease that has needed medical treatment in the past 2 years (hormone replacement therapies such as thyroid or insulin are not considered in this category and are allowed)
• People who have a history of lung inflammation (pneumonitis) or scarring of the lung tissue (interstitial lung disease) that required steroid treatment, or who currently have these conditions
• People who have an active infection that requires medication
• People with a history of severe allergic or anaphylactic reactions to antibodies or similar proteins, or to any component of the study treatments
• People with nerve damage affecting their ability to function (related to one of the study drugs, oxaliplatin)
• People currently taking St John's Wort herbal supplement
• People with chronic inflammatory bowel disease or a bowel blockage (related to one of the study drugs, irinotecan)
• People who have been treated with certain antiviral medicines (brivudine, sorivudine, or similar drugs) within 4 weeks before starting the study (related to one of the study drugs, fluorouracil)
• People with conditions linked to high calcium levels in the blood or urine, including certain types of kidney stones or vitamin D toxicity
• People who are under legal guardianship or have had their liberty restricted
• People who are pregnant, breastfeeding, planning to become pregnant during the trial, or unwilling to use effective contraception for up to 6 months after the last dose of treatment

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