Phase 1 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 80 years old who are able to understand and sign a consent form
• People who have been diagnosed with pancreatic adenocarcinoma (a specific type of pancreatic cancer), confirmed by a tissue or cell sample
• People whose cancer has been assessed by a doctor as either unable to be surgically removed, spread only to nearby lymph nodes, or where surgery is not suitable or has been declined by the patient
• People with a good general health and activity level, as measured by a standard medical scale (ECOG score of 0 or 1 — meaning fully active or restricted in strenuous activity only)
• People with an expected survival of at least 3 months
• People who have exactly one measurable tumour in the pancreas, where the tumour meets specific size requirements on scans (shortest measurement at least 2.0 cm, longest measurement no more than 6.0 cm)
• People whose kidneys, liver, bone marrow, and blood clotting are all functioning within acceptable levels on blood tests (confirm specific values with the trial site)
• People of reproductive age who agree to use effective contraception during the study and for 12 months after receiving the study drug; male participants must also agree not to donate sperm during this period
• Female participants of reproductive age who have a negative pregnancy test during the screening period and within 24 hours before receiving the study drug

Who may not be able to join:

• People who have a known allergy to the study drug NRT6008 or any of its ingredients
• People for whom any of the three chemotherapy options used in this study are not medically suitable, as judged by a doctor
• People who have previously received any treatment for pancreatic cancer, such as chemotherapy, radiation, targeted therapy, or immunotherapy (people who stopped taking traditional Chinese or herbal medicine at least 7 days before screening may still be considered)
• People for whom anaesthesia (being put to sleep for a procedure) is not medically safe
• People who have had another type of cancer within the past 5 years, except for certain fully treated cancers such as some skin cancers, early-stage cervical cancer, early-stage endometrial cancer, or thyroid cancer
• People whose scans show cancer that has spread to distant parts of the body beyond the pancreas and nearby lymph nodes
• People who are pregnant or breastfeeding
• People assessed by a doctor as being at high risk from, or who may have difficulty with, a specific guided injection procedure into the pancreas (EUS-FNI)
• People whose scans show the cancer has grown into the stomach, duodenum (the first part of the small intestine), or the lining of the abdomen
• People with ongoing chronic conditions such as high blood pressure or diabetes that are being treated but are not well managed
• People who experienced acute pancreatitis, severe gastrointestinal bleeding, or serious heart or brain events (such as stroke or unstable chest pain) within 6 months before starting chemotherapy, or who have had an active infection requiring treatment within 2 weeks before screening
• People who have taken part in another interventional clinical trial within 1 month before starting chemotherapy
• People who test positive for HIV
• People who test positive for hepatitis B, unless follow-up testing shows the virus is at very low or undetectable levels (antiviral treatment during the study would be required in this case — confirm with the trial site)
• People who test positive for hepatitis C antibodies, unless follow-up testing confirms the virus is not active
• People with syphilis infection or active tuberculosis
• People considered unsuitable for the trial for any other reason, as determined by the treating doctor

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