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 fully understood the study and have chosen to sign a consent form agreeing to take part
• People aged 18 to 75 years old (including those aged exactly 18 or 75)
• People with a confirmed or potentially surgically removable advanced cancer of the stomach or where the stomach meets the food pipe (gastroesophageal junction), of a specific type called adenocarcinoma, that has not spread to distant parts of the body
• People who have had additional scans (such as a bone scan or abdominal examination) to rule out spread to the bones or lining of the abdomen, if those were considered a possibility
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• People with a general physical functioning score of 0 or 1 on the ECOG scale (meaning fully active or able to carry out light activity), and a body mass index (BMI) of 18 or above
• People whose life expectancy is at least 12 weeks
• People whose blood counts, liver function, and kidney function fall within acceptable ranges, as measured within 14 days before joining the trial (confirm with trial site for exact values)
• Women of childbearing age, or men whose partner could become pregnant, who are willing to use effective contraception throughout the entire treatment period and for 6 months afterwards
• People who are willing to follow the study schedule and attend follow-up appointments

Who may not be able to join:

• People whose cancer tests positive for a protein called HER2
• People who have taken part in another clinical drug trial, or received any other anti-cancer treatment (including chemotherapy, immunotherapy, or targeted therapies), within the 4 weeks before joining
• People who have had another type of cancer in the past 5 years, except for certain skin cancers or early-stage cervical cancer that has been fully treated
• People who have received a live vaccine within 4 weeks before joining, or who may need one during the study
• People who have an active autoimmune disease, or have had one within the 4 weeks before joining
• People who have previously had a bone marrow transplant or an organ transplant from another person
• People who have a condition that prevents them from absorbing medication properly, or who are unable to swallow the study drug (Fruquintinib) as a tablet
• People who are known to be allergic to the study drug or any of its ingredients
• People with significant abnormalities in their blood electrolyte (salt and mineral) levels, as judged by the study doctor
• People with high blood pressure that cannot be controlled with medication (specifically, systolic pressure of 150 mmHg or above and/or diastolic pressure of 100 mmHg or above)
• People with active stomach or bowel conditions such as ulcers, ulcerative colitis, active bleeding from a tumour, or other conditions the study doctor believes could lead to gastrointestinal bleeding or a tear in the gut
• People who have had significant bleeding (more than 30 mL over 3 months, including vomiting blood or blood in stools), coughed up fresh blood (more than 5 mL in 4 weeks), or a stroke or blood clot event within the past 12 months
• People with a recent or significant history of serious heart or brain blood vessel conditions, including heart attack, unstable chest pain, certain irregular heart rhythms, or a stroke within the past 6 months; or people with poor heart pumping function as measured by standard heart tests
• People with a known HIV infection, active hepatitis B or C infection, or liver cirrhosis
• People who are pregnant or breastfeeding
• People with a significant amount of protein in their urine, confirmed by two consecutive tests
• People who have fluid build-up in the abdomen or around the lungs that is causing symptoms
• People who still have side effects from a previous cancer treatment that have not resolved (with some specific exceptions, confirm with trial site)
• People the study doctor considers unsuitable for any other reason

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