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 signed a consent form after being fully informed about the trial's purpose, expected effects, and risks
• People who have been diagnosed with locally advanced pancreatic adenocarcinoma confirmed by tissue or cell testing, or people who have pancreatic cancer that has come back only in the local area (not spread to distant parts of the body) more than 6 months after completing post-surgery treatment
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1)
• People with a general health and activity score (ECOG) of 0 or 1, meaning they are fully active or have only minor restrictions on physical activity
• People with an expected survival of at least 3 months
• People who are willing and able to follow the study procedures, including treatment (possibly including surgery) and follow-up visits
• People who have no medical reasons preventing them from receiving the study drugs (a PD-1 or PD-L1 immunotherapy, gemcitabine, and albumin-bound paclitaxel) or radiotherapy
• People whose blood counts meet the required levels: neutrophils ≥1.5×10⁹/L, platelets ≥80×10⁹/L, and haemoglobin ≥90g/L (confirm with trial site)
• People whose liver function test results fall within the acceptable ranges set by the trial (confirm with trial site)
• People whose kidney function meets the required level: creatinine no more than 1.5 times the normal upper limit, or a calculated kidney clearance rate of at least 50ml/min (confirm with trial site)
• People whose blood clotting test results fall within the acceptable ranges set by the trial, unless they are already on blood-thinning medication (confirm with trial site)
• People who have a hepatitis B surface antigen (HBsAg) positive result but whose hepatitis B virus levels in the blood are within acceptable limits, or whose treating doctor considers their hepatitis B to be stable and not an added risk
• Men and women between 18 and 75 years of age
• People of childbearing age who agree to use adequate contraception throughout the trial; women of childbearing age must have a negative pregnancy test within 24 hours before starting chemotherapy
• Women who are not currently breastfeeding

Who may not be able to join:

• People who have previously received anti-PD-1 or anti-PD-L1 immunotherapy treatment
• People who have taken any experimental drug within 4 weeks before the first dose of the trial drug
• People who are currently enrolled in another clinical trial that involves an active treatment or intervention (observational studies or follow-up phases of other trials may be acceptable — confirm with trial site)
• People who have previously had radiotherapy to the upper abdomen
• People with serious uncontrolled medical conditions — such as severe heart disease, stroke-related disease, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infection, or active stomach ulcers — that their doctor believes would affect their ability to participate
• People with an active, known, or suspected autoimmune disease (such as autoimmune inflammation of the eyes, gut, liver, pituitary gland, kidneys, blood vessels, or thyroid, or asthma requiring airway-opening medication); people with only thyroid replacement hormone needs or skin conditions not requiring systemic treatment (such as vitiligo, psoriasis, or hair loss) may still be eligible
• People with an active tuberculosis infection, or a history of active tuberculosis in the past year, or a history of tuberculosis more than one year ago unless they have completed a full standard course of tuberculosis treatment
• People with a history of interstitial lung disease or non-infectious lung inflammation that required steroid tablets or intravenous steroids
• People who require long-term use of steroid tablets or injections at doses higher than the equivalent of 10mg prednisone per day, or any other ongoing immune-suppressing treatment (inhaled or skin-applied steroids are generally acceptable)
• People with poorly controlled heart conditions, including moderate-to-severe heart failure (NYHA grade 2 or above), unstable chest pain (angina), a heart attack within the past year, or significant irregular heart rhythms requiring treatment
• People with dementia, significantly altered mental state, or a psychiatric condition that would prevent them from understanding and consenting to the trial or completing questionnaires
• People with a known allergy or sensitivity to any component of the study treatment
• People who have had another cancer within the past 5 years, with the exception of certain fully treated skin cancers, localised prostate cancer treated with curative surgery, or breast ductal carcinoma in situ treated with curative surgery
• People who have previously received systemic treatment specifically for locally advanced pancreatic cancer
• People who have been diagnosed with squamous cell carcinoma (in any organ) and have previously received chemotherapy containing taxane drugs (such as paclitaxel) as pre- or post-surgery treatment
• People with moderate or severe nerve damage in the hands or feet (grade 2 or higher peripheral neuropathy according to CTCAE version 5.0)
• People who test positive for hepatitis C antibodies or HIV antibodies
• People with an active infection currently requiring systemic treatment
• People who need to receive additional anti-cancer drug treatments alongside the trial treatment
• People who have received any experimental drug or participated in another interventional trial within 30 days of the screening period
• People whom the trial investigator considers unsuitable for inclusion for any other reason

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