Phase 2 Stomach Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The person has signed a written consent form agreeing to take part in the study.
• The treating doctor believes the person is willing and able to follow the study plan, including having planned surgery.
• The person is 18 years of age or older at the time of signing the consent form.
• The person has been diagnosed with a confirmed type of oesophageal cancer called adenocarcinoma (including cancer at the junction of the oesophagus and stomach), at an early stage, and the treating doctor has determined that surgery to remove the tumour is appropriate.
• The tumour has been assessed as safe and technically possible to remove with surgery.
• The tumour has been tested for a protein called PD-L1 (using a validated local test), and results are available before enrolment; testing for another marker called MSI status and an additional PD-L1 measure is also required, either locally or by providing a tumour sample to the study sponsor.
• The person has not previously received chemotherapy or targeted drug therapy for this cancer.
• The person has not previously had surgery to fully remove the oesophageal or stomach tumour.
• The person has a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions in physical activity (confirm with trial site).
• The person is expected to live for at least 12 weeks.
• People who are able to become pregnant, or men with partners who are able to become pregnant, must agree to use highly effective contraception during treatment and for at least 6 months after the final treatment dose in the main treatment phase, or 3 months after the final dose in the maintenance phase; men must also agree not to donate sperm during this time.
• The person weighs more than 30 kg.
• The person has blood, liver, and kidney function results within the ranges required by the study (confirm specific values with trial site).
• The person does not have HIV infection — although people living with HIV may still be considered eligible if they meet a specific set of conditions related to their HIV treatment and health status (confirm with trial site).

Who may not be able to join:

• The person has a known allergy or severe reaction to durvalumab (the study drug) or to similar types of antibody-based medicines.
• The person has a known allergy or medical reason preventing use of any of the chemotherapy drugs in this study: docetaxel, 5-FU, leucovorin, or oxaliplatin.
• The person has a known complete deficiency of an enzyme called DPD, which affects how the body processes one of the chemotherapy drugs (people with only a partial reduction in this enzyme may still be considered, with a lower drug dose).
• The person has an active autoimmune disease or a history of one — such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease, among others. Some milder conditions, such as well-controlled thyroid conditions, Type 1 diabetes, or limited skin conditions like eczema or psoriasis, may still be eligible depending on how well controlled they are (confirm with trial site).
• The person has previously had a bone marrow transplant or solid organ transplant (such as a kidney or liver transplant).
• The person has a history of lung scarring or inflammation conditions (such as pulmonary fibrosis or certain types of pneumonitis), or shows signs of active lung inflammation on a recent chest scan.
• The person has active hepatitis B or hepatitis C infection. People with a past hepatitis B infection that has fully resolved, or hepatitis C where a specific RNA test comes back negative, may still be considered eligible (confirm with trial site).
• The person has active tuberculosis.
• The person has cancer-related pain that is not well controlled with medication.
• The person has received a live vaccine within four weeks before enrolment, or is expected to need one during the study or within 30 days after the last dose of the study drug durvalumab.
• The person has previously been treated with certain immune-based therapies, including checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies.
• The person has received immune-stimulating medications (such as interferons or interleukin-2) within four weeks, or five half-lives of that drug, before joining the study.
• The person has taken systemic (whole-body) corticosteroids or other immune-suppressing medications within two weeks before starting the study treatment, with some exceptions for low-dose or inhaled forms (confirm with trial site).
• The person has a significant heart condition, has had a heart attack or stroke within the past three months, or has unstable heart rhythms or unstable chest pain (angina).
• The person has a clinically significant heart valve problem.
• The person has had another type of cancer within the past five years, with some exceptions for certain low-risk cancers that have been fully treated (confirm with trial site).
• The person has nerve damage in the hands or feet (peripheral neuropathy) rated at grade 2 or higher on a standard medical scale.
• The person has uncontrolled high calcium levels in the blood.
• The person has had a serious infection requiring antibiotic treatment within 14 days before enrolment.
• The person has chronic inflammatory bowel disease.
• The person has active, clinically significant bleeding in the digestive tract.
• The person has had a major surgical procedure (other than for diagnosis) within four weeks before starting the study treatment.
• The person has any other significant medical, neurological, or metabolic condition that the treating doctor believes could make participation unsafe or affect the study results.
• The person has taken part in another interventional clinical trial within 30 days before joining this study, or is currently enrolled in another such trial.
• The person has taken an experimental drug within 28 days before starting the study treatment.
• The person is pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after the end of treatment. A negative pregnancy blood test within 7 days before starting treatment is required for people who could become pregnant.

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