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 confirmed by a local pathologist to have a type of pancreatic cancer called adenocarcinoma, located in any part of the pancreas
• People whose cancer is classified as "borderline resectable" (meaning surgery is possible but complex), confirmed by a team of specialists using CT and/or MRI scans with contrast dye
• People whose cancer has not spread to distant parts of the body (stage T1–4, N0–2, M0)
• People aged 18 or older
• People who have not previously received chemotherapy or radiation treatment for pancreatic cancer
• People with a good general level of physical functioning (able to carry out daily activities with minimal limitations, ECOG score 0 or 1)
• People without significant nerve damage (no grade 2 or higher neuropathy)
• People whose blood test results meet specific thresholds, including adequate white blood cell counts, platelet levels, haemoglobin, kidney function, liver function, and a tumour marker called CA 19.9 below 2,500 kU/l before any treatment

Who may not be able to join:

• People whose cancer has spread outside the pancreas, including to distant lymph nodes or other organs, as seen on imaging or confirmed by biopsy or surgery
• People whose cancer is considered "locally advanced" — meaning it wraps too far around nearby major blood vessels to allow safe surgery (confirm with trial site)
• People with a CA 19.9 tumour marker level above 2,500 kU/l before any treatment (in the absence of a bile duct blockage)
• People for whom surgery is not medically safe for any reason
• People who cannot receive the chemotherapy drugs used in this trial (FOLFIRINOX or gemcitabine plus nab-paclitaxel)
• People who have previously had radiation treatment to the upper abdomen
• People who have previously been treated with oxaliplatin, irinotecan, fluorouracil, or capecitabine
• People under 18 years of age
• People who have had major surgery within 4 weeks before entering the trial
• People with serious uncontrolled health conditions, including active infection, significant heart problems, or mental health or social circumstances that would make it difficult to follow the treatment plan
• People currently receiving other cancer treatments
• People who have or have had another active cancer, except certain low-risk conditions (basal cell skin cancer, early-stage cervical cancer, or non-spreading prostate cancer); people with a past cancer history must have been in remission for more than 5 years
• Women who are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test within 7 days before registering, and must have been using reliable contraception for at least 1 month before starting treatment
• People regularly taking certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors); these medications must be stopped at least 14 days before registering (confirm specific medications with trial site)

Additional criteria checked before a later stage of the trial (randomisation):

• People whose cancer has grown or spread during the first phase of chemotherapy (4 cycles), or whose CA 19.9 has risen by 20% or more
• People whose CA 19.9 remains above 1,000 kU/l after the initial chemotherapy phase
• People who experienced serious side effects during the first phase of chemotherapy that could not be managed
• People whose tumour measures more than 7.0 cm at its widest point at the time of randomisation
• People whose cancer has heavily grown into the stomach or intestines, including visible invasion of the inner lining seen on internal ultrasound
• People with an active stomach or duodenal ulcer at the time of randomisation (a past ulcer that is no longer active may be acceptable, confirmed by endoscopy)

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