Phase 2 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:

• A diagnosis of pancreatic adenocarcinoma (a specific type of pancreatic cancer) that has been confirmed by a tissue sample — other types of pancreatic cancer are not eligible
• Cancer that has been staged as T1–T3, N0–N2, M0, meaning it has not spread to distant parts of the body (confirm with trial site)
• Cancer that is considered surgically removable ("resectable") based on specific detailed CT scan results, with no tumour touching key arteries, and either no tumour touching key veins or only limited contact without vein damage
• People aged 18 years or older
• Willingness to have a biopsy before treatment, a biopsy during treatment, and to undergo surgery to remove the tumour
• A general health and activity level rated as ECOG 0 or 1, meaning fully active or able to carry out light work (confirm with trial site)
• No previous treatment received for pancreatic cancer
• Blood test results showing the kidneys, liver, bone marrow, and blood clotting are all functioning within acceptable ranges as determined by the trial
• Ability to understand, agree to, and sign a consent form, and willingness to attend all required visits and follow the study schedule
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or who agree to use contraception during treatment and for at least 150 days after the last dose of study treatment
• Men who are sexually active with women who could become pregnant must agree to use contraception throughout treatment and for 180 days after completing treatment, and must not donate sperm during this time

Who may not be able to join:

• Cancer that is borderline resectable, locally advanced, or has spread to other parts of the body
• A medical condition that makes surgery to remove the pancreatic cancer too risky
• An active autoimmune disease (where the immune system attacks the body) that has needed systemic medical treatment in the past two years — hormone replacement therapies such as thyroid or insulin are not considered systemic treatment for this purpose
• A condition that requires ongoing treatment with corticosteroids (steroid medicines) at doses above 10mg per day (confirm with trial site)
• Symptomatic lung disease affecting the lung tissue in a way that could interfere with detecting or managing treatment side effects in the lungs
• An active, uncontrolled infection requiring antibiotic, antiviral, or antifungal medicine taken by injection or by mouth in the 28 days before screening
• A condition requiring long-term daily antibiotic or antifungal medicine
• An uncontrolled inflammatory bowel condition, such as Crohn's disease or ulcerative colitis
• A known or suspected active autoimmune disease
• Receipt of a live or live-attenuated vaccine within 30 days before the first dose of study treatment (note: certain vaccines given before a planned spleen removal may be permitted — confirm with trial site)
• Use of probiotic supplements within 28 days before screening
• Known HIV infection, known active Hepatitis A, or known Hepatitis B
• A history of acute diverticulitis (inflammation of the bowel) in the past 6 months, or ongoing chronic diarrhoea
• A need for any other cancer treatment or surgery while on the study
• Pre-existing nerve damage in the hands or feet rated above Grade 1 in severity (confirm with trial site)
• Pregnancy or breastfeeding
• A positive pregnancy test within 72 hours before registration, or no pregnancy test taken before registration, for women who could become pregnant
• Women who could become pregnant who are unwilling or unable to use an accepted contraception method throughout the study and for 150 days after the last dose (women who are not sexually active with men are still required to undergo pregnancy testing)
• Sexually active men who are not using effective contraception if their partner could become pregnant
• A history of a primary immune deficiency condition
• A past history of non-infectious pneumonitis (lung inflammation) that required steroid treatment, or current pneumonitis
• A history of receiving a transplanted organ or bone marrow from another person
• Any previous radiation therapy, immunotherapy, or targeted biological therapy for the pancreatic tumour (a biliary stent is permitted)
• Treatment for another invasive cancer within the past two years where the risk of that cancer returning is greater than 5% — carcinoma in situ and certain skin cancers are permitted
• Participation in another clinical drug trial within 4 weeks before starting this study
• Major surgery (not including keyhole/laparoscopic procedures) within 4 weeks before starting the study, without full recovery
• A known allergy to the study treatments or any of their ingredients

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