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 are able to give signed consent to participate.
• People who are 18 years of age or older at the time of giving consent.
• People who are generally well enough to carry out daily activities with little or no limitation (measured by a standard health scale called ECOG, with a score of 0 or 1).
• People who have been confirmed by laboratory testing to have stomach (gastric) or gastroesophageal junction (GEJ) cancer of a specific type called adenocarcinoma, at a stage that has not spread to distant organs and where surgery to remove the cancer is considered possible by the medical team.
• People whose tumour tests negative for a protein called HER2 (confirmed by specific laboratory tests).
• People whose blood counts and organ function meet specific minimum levels, including red blood cells, white blood cells, platelets, liver function markers, kidney function, and protein levels in the blood (confirm specific values with the trial site).
• People who are willing and able to have tumour tissue samples (biopsies) taken before and during treatment.
• Women who could become pregnant must have a negative pregnancy blood test within 72 hours before the first dose, and must agree to use effective contraception during treatment and for 9 months after the last dose.
• Men with female partners who could become pregnant must agree to use effective contraception during treatment and for 6 months after the last dose.

Who may not be able to join:

• People whose stomach or GEJ cancer is not the adenocarcinoma type — for example, those with squamous cell, neuroendocrine, or gastrointestinal stromal tumour types.
• People whose tumour tests positive for the HER2 protein (confirmed by specific laboratory tests).
• People who have already received any cancer treatment for this disease, such as chemotherapy, radiation, or other approved or experimental therapies.
• People who have previously received certain types of immunotherapy drugs known as anti-PD1 or anti-CTLA4 antibodies, even if those were used for a different cancer in the past.
• People with certain underlying health conditions that the treating doctor considers would make the study drug unsafe to use, including a history of lung inflammation (interstitial lung disease or pneumonitis), serious active infections requiring intravenous treatment, significant heart or blood vessel disease, unresolved side effects from a previous experimental drug, or a history of organ or bone marrow transplant.
• People who need ongoing use of high-dose steroid medications or immune-suppressing drugs for a chronic condition.
• People with an active autoimmune disease, or a history of autoimmune disease that required systemic treatment in the past 2 years — though some conditions such as vitiligo, stable hypothyroidism managed with hormone replacement, mild asthma managed with inhalers, or Sjögren's syndrome may still be eligible (confirm with trial site).
• People who have a known allergy to any ingredient in the study drug formulation.
• People who have had another active cancer within the past 2 years, although some minor skin cancers or other locally treated cancers that appear fully resolved may still be considered eligible after discussion with the trial doctor.
• People with HIV who have a detectable amount of virus in their blood — though people on effective HIV treatment with an undetectable viral load in the past 6 months may still be considered eligible.
• People with active, untreated hepatitis B infection — though people on suppressive therapy with an undetectable viral load may still be considered eligible.
• People with hepatitis C infection who have detectable virus in their blood — though people currently on hepatitis C treatment with an undetectable viral load may still be considered eligible.
• People who have received a live attenuated vaccine (a type of vaccine made from a weakened live virus) within 30 days before starting study treatment.

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