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:

• People aged 18 or older
• People who have been confirmed by laboratory testing (from tissue or cell samples) to have stomach cancer or cancer where the stomach meets the oesophagus
• People whose cancer stopped responding to a first round of treatment that included a type of immunotherapy drug called a PD-1 or PD-L1 inhibitor
• People who have at least one area of cancer that can be measured on a scan, according to standard research guidelines
• People who are reasonably well and able to carry out daily activities, based on a standard medical scoring scale (a score of 0 or 1 on the ECOG scale)
• People whose doctors expect them to live for at least 3 more months
• People whose blood counts and organ function meet specific levels — including healthy enough levels of white blood cells, platelets, red blood cells, kidney function, liver function, and urine protein — as determined by recent blood and urine tests
• People whose blood clotting levels fall within an acceptable range, with no history of active bleeding or clotting disorders
• People who are able to use an effective form of birth control during the study and for 3 months after, if there is any chance of pregnancy, and who have a negative pregnancy blood test within 3 days before joining
• People who are not currently breastfeeding
• People who are willing and able to give written consent and follow the trial schedule, including visits, tests, and procedures

Who may not be able to join:

• People who have had a hole or abnormal opening in the digestive tract (such as a perforation or fistula) within the past 6 months
• People who have uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained repeatedly
• People who have had a serious allergic reaction to monoclonal antibodies, or to either of the specific study drugs (fruquintinib or albumin-bound paclitaxel)
• People who had severe side effects from previous immunotherapy treatment
• People who have previously been treated with a type of drug called a CTLA-4 inhibitor
• People who have taken another experimental drug within the past 4 weeks
• People who are currently enrolled in another clinical trial that involves an active treatment (not just observation or follow-up)
• People who had their last cancer treatment less than 3 weeks before joining, or targeted radiotherapy less than 2 weeks before joining
• People who have been taking steroid medicines at a dose higher than a low daily threshold within the past 2 weeks (some exceptions apply — confirm with trial site)
• People who received a cancer vaccine or live vaccine within the past 4 weeks
• People who had major surgery or a serious physical injury within the past 4 weeks
• People who still have significant side effects from previous cancer treatment that have not settled down to a mild level
• People who have cancer that has spread to the brain or spinal cord
• People with a history of active autoimmune diseases (conditions where the immune system attacks the body), such as certain lung, bowel, liver, or thyroid conditions — some exceptions apply, such as well-controlled thyroid conditions or type 1 diabetes (confirm with trial site)
• People with a weakened immune system, including those who are HIV-positive, have had an organ transplant, or have had a bone marrow transplant from a donor
• People with significant heart problems, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, or uncontrolled abnormal heart rhythms
• People with high levels of protein in their urine, confirmed by a 24-hour urine test
• People with abnormal blood clotting results or who are on blood-thinning treatment (some low-dose preventive blood thinners may be allowed — confirm with trial site)
• People who have had noticeable bleeding within the past 3 months, such as from the stomach or gut
• People with active ulcers, wounds that have not healed, or unhealed bone fractures
• People with high blood pressure that is not well controlled by medication (above 140/90 mmHg)
• People who have had a serious infection within the past 4 weeks, or who have signs of active lung infection or are currently on antibiotic treatment (other than for prevention)
• People with a history of scarring or inflammation of the lung tissue (interstitial lung disease), with some exceptions (confirm with trial site)
• People with active tuberculosis (TB), a history of active TB within the past year, or untreated TB from more than a year ago
• People who have had another type of cancer within the past 5 years, except for certain very low-risk cancers that are considered effectively treated (such as some skin cancers or early cervical changes)
• People who are pregnant or breastfeeding
• People who, in the treating doctor's judgement, have other serious conditions — including significant mental health conditions or very abnormal test results — that could make it unsafe or impractical for them to continue in the study

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