Phase 2 Stomach 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 newly diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus that has spread to other parts of the body, cannot be surgically removed, or has come back
• People whose cancer has spread to the lining of the abdomen and who have a moderate-to-severe build-up of fluid in the abdomen, confirmed by a CT scan
• People whose cancer cells test positive for a protein called PD-L1, with a score of 5 or higher on a specific laboratory test (the 28-8 assay)
• People who are able to understand and sign a consent form agreeing to take part in the trial
• People who are older than 19 years at the time of joining the trial
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1)
• People who are expected to live for more than 4 months
• People who weigh more than 30 kg
• People who do not have any existing nerve damage (neuropathy)
• People whose blood counts and organ function (including blood cells, liver, and kidneys) meet the minimum levels required by the trial (confirm with trial site for specific values)
• Women who are past menopause or who have a negative pregnancy test before starting the trial
• People who are willing and able to attend all required appointments and follow the trial schedule for its full duration

Who may not be able to join:

• People whose cancer got worse within 6 months of finishing a course of chemotherapy given after surgery
• People who have taken part in another clinical trial involving an experimental treatment in the last 2 weeks
• People who are currently enrolled in another interventional clinical trial
• People who are currently receiving any chemotherapy, immunotherapy, or other cancer treatments (hormone therapy for non-cancer reasons, such as menopause, is generally acceptable)
• People who have had a major surgery within 28 days before the first treatment dose
• People who are unable to swallow and take medication by mouth
• People who have gastrointestinal (gut) bleeding
• People who have difficulty absorbing nutrition through the gut
• People who have previously received an organ transplant from another person
• People with serious uncontrolled illnesses, such as active infections, severe heart problems, uncontrolled high blood pressure, unstable chest pain, irregular heartbeat, lung disease, severe ongoing diarrhoea, or significant mental health conditions that could affect their ability to take part safely
• People who have had another type of cancer in the past, unless it was successfully treated at least 5 years ago with a low chance of returning, was a type of non-melanoma skin cancer fully treated with no signs of return, or was a pre-cancerous condition that was fully treated with no signs of return
• People with a history of a condition where the immune system does not work properly from birth or early life
• People with an active infectious illness
• People with tuberculosis (TB), based on medical history, examination, imaging, or testing
• People who test positive for active Hepatitis B virus (HBsAg positive)
• People who test positive for Hepatitis C antibodies, unless a further test (PCR) confirms the virus is no longer active
• People who test positive for HIV
• People who are pregnant or breastfeeding, or people of childbearing or fathering potential who are not willing to use effective contraception from the time of screening until 5 months after the last dose of the study drug lenvatinib
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People with a known deficiency of an enzyme called dihydropyrimidine dehydrogenase (DPD)
• People with certain rare inherited conditions affecting how the body processes certain sugars, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

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