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 are willing to take part voluntarily and sign a consent form.
• People who are 18 years old or older at the time of signing the consent form.
• People who have been diagnosed with a specific type of pancreatic cancer called pancreatic ductal adenocarcinoma (including a related type called adenosquamous carcinoma), confirmed by laboratory testing of tissue.
• People who have not previously received any systemic (whole-body) treatment for pancreatic cancer that has spread or cannot be surgically removed — though people who received certain earlier treatments (such as chemotherapy or chemoradiotherapy before or after surgery) may still be eligible if at least 6 months passed between the end of that treatment and when the cancer came back or got worse.
• People who have at least one measurable area of cancer that meets specific measurement standards (called RECIST 1.1); if there is only one such area and it was previously treated with radiation, there must be clear evidence it has grown since then.
• People who are reasonably well and able to carry out daily activities, as measured by a standard health scale (ECOG score of 0–2).
• People who are expected to live for more than 3 months.
• People who are able to swallow and take oral (by mouth) chemotherapy tablets or capsules.
• People whose heart, liver, kidneys, and other organs are functioning well enough to meet the trial's required levels (confirm specific values with trial site).
• People of childbearing potential (both female and male participants whose partners could become pregnant) who agree to use reliable contraception starting 7 days before entering the trial and continuing until 24 weeks after treatment begins; female participants must also have a negative pregnancy blood test within 7 days before entering the trial.

Who may not be able to join:

• People who have cancer that has spread to the brain or the lining around the brain that has not been treated — though people whose brain metastases have been treated and are stable (with stable scans for at least 4 weeks and no new symptoms) may still be considered.
• People with untreated compression fractures of the spine; those with treated spinal compression fractures must have been stable for at least 2 weeks beforehand.
• People who have already received systemic (whole-body) treatment for pancreatic cancer that has spread or cannot be surgically removed — including those who received earlier chemotherapy or chemoradiotherapy and whose cancer returned or got worse within 6 months of finishing that treatment.
• People with a high risk of serious bleeding in the stomach or abdomen.
• People whose cancer pain is not well controlled at the time of joining (for example, people who need their pain medication to be regularly increased).
• People who received chemotherapy, targeted therapy, immunotherapy, or other cancer treatments within the 28 days before joining, or who used traditional Chinese herbal medicines with anti-cancer effects within 14 days before joining.
• People who have had major surgery within 28 days before joining (routine diagnostic procedures such as needle biopsies are generally not counted).
• People who received high-dose (radical) radiation therapy within the 3 months before joining; limited (palliative) radiation is allowed if it finished at least 2 weeks before the start of trial treatment.
• People who have had another type of cancer in the past 5 years, with some exceptions — certain skin cancers, non-invasive bladder cancer, or cancers of the prostate, cervix, or breast that have been fully cured may still be eligible (confirm with trial site).
• People with serious uncontrolled health conditions, including active hepatitis B or C infection above certain levels, known HIV infection or AIDS, active syphilis, active tuberculosis, other active infections, poorly controlled high blood pressure, significant heart failure, unstable chest pain (angina), a heart attack within the last 6 months, or certain heart rhythm problems.
• People with active or uncontrolled bleeding.
• People who still have significant side effects from previous cancer treatments that have not improved sufficiently (most side effects need to have settled to a mild level; hair loss is an exception and is allowed at any level, and nerve-related symptoms need only have settled to a moderate level).
• Women who are currently breastfeeding.
• People with certain mental health conditions, or significant fluid build-up around the lungs, heart, or abdomen, that in the treating doctor's opinion could affect safety or the reliability of the study results.
• People who may have difficulty giving fully informed consent or following the study requirements, including those with cognitive impairments, critically ill individuals, minors, pregnant women, or people who are in a dependent relationship with the research team or study institution.

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