Phase 3 Pancreatic Cancer Trial, Recruiting

Written by an AI model from the 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 had surgery to remove pancreatic cancer (confirmed by laboratory testing of the removed tissue), where the surgery aimed to remove all of the cancer, and who have already completed 3 months of pre-surgery chemotherapy using a regimen called mFOLFIRINOX — including people whose tumour was considered removable or borderline removable before surgery
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (ECOG score of 0 or 1)
• People whose blood level of a tumour marker called CA 19-9 is 200 U/ml or below
• People aged 18 years or older
• People whose blood test results show adequate levels of infection-fighting cells, platelets, kidney function, and haemoglobin (red blood cell levels) — blood transfusions to reach the haemoglobin requirement are permitted (confirm specific values with trial site)
• Women who could become pregnant must have been using an approved highly effective form of contraception for at least one month before joining, must continue using it during and for 15 months after chemotherapy, and must have a negative blood pregnancy test at the time of joining and before each treatment cycle; women who have had a hysterectomy, removal of both fallopian tubes, or removal of both ovaries are also eligible
• Women who are post-menopausal, defined as having had no periods for at least 12 months without another medical explanation
• Men participating in the trial must use contraception throughout the trial and for 12 months after finishing chemotherapy
• People who are enrolled in a national health insurance (social security) plan
• People who, in the opinion of the investigator, are able to follow the study procedures
• People who have read and understood the information provided about the trial and have signed a consent form

Who may not be able to join:

• People whose post-surgery scans show the cancer has spread to other parts of the body (metastatic disease)
• People whose cancer is a type other than pancreatic adenocarcinoma, such as bile duct cancer, ampullary cancer, or other pancreatic tumour types
• People with serious or uncontrolled heart conditions, including heart failure, untreated angina, a heart attack within the past year, persistently high blood pressure despite treatment, or a heart rhythm abnormality called long QT
• People with a serious uncontrolled infection, a chronic infectious disease, or an immune deficiency condition
• People with certain pre-cancerous blood or bone marrow disorders, such as myelodysplastic syndrome
• People with severe liver failure
• People with a current or past history of another cancer, except for: the pancreatic cancer being treated in this trial; certain skin cancers (basal cell or squamous cell) that have been fully treated; cervical carcinoma in situ; or another cancer that has been fully treated with no return for at least 2 years
• People with any medical, psychological, or social situation that, in the investigator's opinion, could affect their ability to follow the study procedures, contribute reliable data, understand what participation involves, or give informed consent
• Women who are pregnant or breastfeeding, or women who could become pregnant and are not using effective contraception
• People already participating in another clinical trial that uses the same main outcome measure as this trial
• People whose freedom is restricted by an administrative or legal decision, or who are under legal guardianship or court protection
• People whose blood test shows a uracil level of 150 ng/ml or above, which may suggest a complete deficiency of an enzyme called DPD (involved in processing certain chemotherapy drugs)
• People who have a medical reason they cannot receive any of the chemotherapy drugs used in this trial: Gemcitabine, Nab-Paclitaxel, Oxaliplatin, Folinic Acid (Leucovorin), Irinotecan, or Fluorouracil

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