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 years, of any gender
• People who have been diagnosed with pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer), confirmed by a tissue or cell sample
• People whose cancer imaging shows the disease is locally advanced — meaning it has grown into nearby blood vessels in specific ways — but has not spread to distant parts of the body
• People whose cancer has a specific genetic change called a KRAS G12D mutation, confirmed by a tissue sample or blood test
• People who are generally well enough to carry out daily activities with little or no limitation (this is measured using a standard scale called ECOG, with a score of 0 or 1)
• People who have not had any previous cancer treatment, including radiation, chemotherapy, targeted therapy, or immunotherapy
• People who have at least one tumour that can be measured on imaging scans, according to standard measurement guidelines
• People who had a blocked bile duct that has already been treated and cleared before joining the study, and whose expected survival is more than 3 months
• People who have signed a consent form agreeing to take part before any study procedures begin
• People whose blood test results show that the liver, kidneys, bone marrow, and heart are functioning within acceptable ranges (tested within 7 days before starting treatment, without recent use of blood products or growth factor medications to boost those results)
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose and must not be breastfeeding; women and men who could father or become pregnant must agree to use effective contraception from the time of signing the consent form until 180 days after the last study dose

Who may not be able to join:

• People with certain serious complications related to their tumour, such as high blood pressure in the portal vein system, transformation of portal vein blood vessels, bleeding in the digestive tract caused by the tumour, an abnormal opening (fistula) or pocket of infection (abscess) in the abdomen, or a specific type of severe blood vessel damage around major arteries
• People who have been diagnosed with another cancer within the past 5 years (except for certain fully treated skin cancers or non-invasive cancers)
• People who have had an active autoimmune disease requiring systemic (whole-body) medication treatment within the past 2 years — note that hormone replacement therapies for conditions like thyroid or adrenal problems are not counted as exclusions
• People currently using systemic steroid medications or other immune-suppressing medicines within 7 days before the first dose — small daily doses of steroids (equivalent to 10 mg or less of prednisone per day) may be acceptable (confirm with trial site)
• People who have received an organ transplant or bone marrow/stem cell transplant from another person (corneal transplants are excluded from this rule)
• People with a history of significant allergic reactions or drug hypersensitivity, as assessed by the treating doctor
• People with clinically significant acute or ongoing pancreatitis (inflammation of the pancreas)
• People with a history of drug abuse, chronic heavy alcohol use, or a positive HIV test
• People with uncontrolled active hepatitis B infection — people with certain lower-level or inactive hepatitis B may be eligible under specific conditions, which the trial site would assess
• People with active hepatitis C infection confirmed by blood tests
• People who have received a live vaccine within 28 days before the first dose, or who are expected to need one during the study — inactivated flu vaccines are permitted, but live nasal flu vaccines are not
• People who have had major surgery within 28 days before the first dose, minor surgical procedures (such as biopsy or drainage) within 7 days before the first dose, or who have wounds that are not healing or untreated bone fractures
• People with serious or uncontrolled health conditions, including significant heart rhythm problems, unstable chest pain, moderate-to-severe heart failure, a recent heart attack or stroke (within 6 months), poorly controlled blood pressure, active or recent serious lung disease, active tuberculosis, active uncontrolled infection, active gut or abdominal problems such as diverticulitis or bowel blockage, significant liver disease such as cirrhosis, or certain abnormal cholesterol or fat levels in the blood
• People with significant narrowing of the carotid arteries (blood vessels in the neck) shown on ultrasound, or with two or more high-risk fatty deposits in those arteries
• People who have had a serious infection within 28 days before the first dose, including infections requiring hospitalisation or intravenous antibiotics — people taking preventative antibiotics may still be eligible (confirm with trial site)
• People who, in the opinion of the doctor running the trial, have any other medical history, condition, or test result that could affect the trial results, prevent them from completing the study, or put them at risk

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