Phase 1 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 who are able to understand the study and are willing to sign a consent form agreeing to take part.
• People who are willing and able to follow all study procedures and attend follow-up appointments.
• People aged between 18 and 75 years old (inclusive).
• People who have been diagnosed with advanced or metastatic stomach cancer or cancer at the junction of the stomach and oesophagus, confirmed by tissue or cell testing, where the cancer is HER-2 negative, and who have not previously received systemic treatment for this advanced disease (prior treatment given before or after surgery counts as untreated if the cancer came back more than 6 months after that treatment ended).
• People who have at least one tumour that can be measured on a CT or MRI scan, according to standard measurement guidelines.
• People who are able to eat and drink normally by mouth.
• People with a physical fitness score of 0 or 1 on the ECOG scale, meaning they are either fully active or have only minor limitations in physical activity (confirm with trial site).
• People whose doctors expect them to live for more than 3 months.
• People whose blood, liver, and kidney test results fall within the ranges required by the trial (the trial site will check specific values including blood counts, kidney function, liver function, and blood clotting).
• People who are willing to use effective contraception during treatment and for at least 6 months after the last dose.

Who may not be able to join:

• People who have had major surgery (not including needle biopsy) or a serious injury within the 4 weeks before starting the trial, or who are planning to have elective surgery during the trial.
• People whose cancer has spread to the brain or central nervous system with symptoms, or where the condition is unstable or requires high doses of steroids to manage.
• People who have another active cancer, except for certain low-risk cancers that have been fully treated with no recurrence in the past 3 years, fully removed skin cancers, or fully removed non-invasive cancers.
• People who have an active infection (such as viral, bacterial, or fungal) that requires treatment throughout the body.
• People who currently have a lung condition called interstitial lung disease (except for radiation-related scarring that does not need hormone treatment).
• People who have had active bleeding in the past 4 weeks, are at risk of a hole forming in the digestive tract, have a recent surgical wound that has not healed, or have had wound healing complications after surgery.
• People who had bleeding in the digestive tract within the 3 months before starting the trial without confirmed recovery shown by a scope examination, or who have had a serious digestive tract illness in the 2 weeks before starting.
• People with a history of serious heart or blood vessel problems, including dangerous heart rhythm problems, a heart attack, heart failure, stroke, or certain other serious heart or vascular events in the past 6 months; severely reduced heart pumping function; abnormal heart electrical readings on ECG beyond certain thresholds; uncontrolled high blood pressure; or other factors that raise the risk of heart rhythm problems (confirm specific thresholds with trial site).
• People who received certain blood-boosting medicines (such as colony-stimulating factors or erythropoietin) within the 2 weeks before starting the trial.
• People who received a live vaccine within the 4 weeks before starting the trial (live vaccines include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, typhoid, and nasal spray flu vaccines; injected flu vaccines are generally permitted).
• People who are currently taking long-term non-steroidal anti-inflammatory drugs (such as ibuprofen or indomethacin) or anti-platelet drugs (such as clopidogrel), noting that low-dose aspirin up to 325mg per day is permitted.
• People with a history of clinically significant liver disease, including active hepatitis B or C (with detectable virus levels), liver-related brain problems, combined liver and kidney failure, or moderate-to-severe liver scarring (cirrhosis).
• People with a known history of HIV infection or other conditions that weaken the immune system.
• People who are preparing for or have previously had an organ or tissue transplant.
• People with a known allergy to the study drugs or to similar biological medicines such as monoclonal antibodies or protein-based treatments.
• People with a known dependence on alcohol or drugs.
• People who are pregnant (confirmed by a blood test) or who are currently breastfeeding.
• People with known signs of active bleeding within the tumour.
• People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires repeated draining — though a small amount of fluid in the abdomen seen on imaging without symptoms may be acceptable (confirm with trial site).
• People known to have a deficiency of an enzyme called DPD, or who have previously experienced severe mouth or digestive tract inflammation (grade 3 or above) during treatment with fluorouracil-type medicines.
• People with a blockage affecting the heart, stomach outlet, or who experience frequent vomiting (3 or more times within 24 hours).
• People who had a bowel obstruction or certain bowel conditions (including inflammatory bowel disease, Crohn's disease, ulcerative colitis, or major bowel removal surgery) within the 3 months before starting the trial.
• People who have had a serious blood clot (such as a deep vein clot or a clot in the lungs) within the 3 months before joining, or who need certain types of blood-thinning medicines during the study.
• People who need ongoing immune-suppressing medicines within 14 days before starting or during the trial, with some limited exceptions such as low-dose or locally applied steroids (confirm with trial site).
• People whom the trial doctors consider unsuitable for other reasons.

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