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 diagnosed with stomach cancer (specifically a type called adenocarcinoma) that has spread to other parts of the body, confirmed by a tissue or cell sample.
• People who have only received one round of treatment for their cancer, including those whose cancer came back during or within 6 months of finishing an earlier preventative treatment course.
• People whose general health and ability to carry out daily activities meets a specific fitness standard (rated 0 or 1 on a medical scale — roughly meaning fully active or able to carry out light work).
• People whose tumor tests positive for a protein called HER2 must have previously been treated with a medicine called Herceptin (trastuzumab).
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines.
• People aged between 20 and 80 years.
• People whose doctors estimate they have a life expectancy of at least 3 months.
• People whose kidneys are functioning well enough to meet specific blood test thresholds (confirm with trial site).
• People whose liver is functioning well enough to meet specific blood test thresholds (confirm with trial site).
• People whose bone marrow is producing enough blood cells to meet specific blood count levels — blood transfusions or supportive injections before joining may be allowed (confirm with trial site).
• People whose blood clotting levels fall within certain acceptable ranges on specific tests (confirm with trial site).
• People whose urine protein levels fall within acceptable limits on testing (confirm with trial site).
• People of childbearing potential, and their partners, where effective contraception is used throughout the study period.
• Female participants of childbearing potential who have a negative pregnancy blood test within 7 days before the first dose of treatment.
• People who are able to understand and are willing to sign a written consent form agreeing to take part.

Who may not be able to join:

• People who are unable to swallow or take medications by mouth.
• People with a known allergy or sensitivity to irinotecan, fluoropyrimidine, or ramucirumab (medicines used in this trial).
• People who have had surgery in the 4 weeks before joining the trial.
• People experiencing moderate-to-severe diarrhoea or fluid build-up in the abdomen (grade 2 or higher).
• People currently dealing with a serious active infection being treated with intravenous (drip) antibiotics.
• People who have had a serious heart or blood vessel event — such as a heart attack, stroke, mini-stroke, or unstable chest pain — within the 6 months before starting treatment.
• People who have had a hole or abnormal opening in their digestive tract within 6 months before starting treatment, or who have known risk factors for this occurring.
• People with liver scarring (cirrhosis) at a moderate-to-severe level, or any degree of cirrhosis combined with a history of brain problems caused by liver disease, or significant fluid build-up in the abdomen due to cirrhosis that has required medication or procedures to manage.
• People with a wound, ulcer, or bone fracture that has not healed within the 28 days before starting treatment.
• People who have had major surgery within 28 days before starting treatment, or minor surgery or a port/catheter placement within 7 days before starting treatment, or who have planned major surgery scheduled during the trial.
• People with high blood pressure that has not been controlled (above 160/100 mmHg for more than 4 weeks) despite standard treatment.
• People who have had significant bleeding in the digestive tract at a serious level (grade 3–4) within the 3 months before starting treatment.
• People who have had a serious blood clot in a vein — such as a deep vein thrombosis or a clot in the lungs — within the 3 months before starting treatment (minor clots in ports or surface veins are not included).
• People who are currently taking ongoing blood-thinning medications such as clopidogrel or dipyridamole (low-dose aspirin up to 325 mg daily is permitted).
• People who have previously been treated with nal-IRI (ONIVYDE®), TAS-102 (LONSURF®), or ramucirumab.
• People who have been diagnosed with another cancer within the past 5 years, except for certain early-stage skin cancers or stage I cervical cancer.
• People who are pregnant or currently breastfeeding.

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