Phase 3 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 confirmed by laboratory testing to have a specific type of stomach or gastroesophageal junction cancer (called intestinal type adenocarcinoma) that is HER-2 negative (a specific protein marker test result).
• People whose cancer is locally advanced (has grown into the stomach wall or nearby structures) but has not spread to distant parts of the body, based on standard staging.
• People with a specific tumour location type called Siewert type 2 or 3; those with Siewert type 1 may also be eligible if their planned treatment involves chemotherapy before surgery followed by surgical removal (confirm with trial site).
• People aged 18 to 75 years at the time of signing the consent form.
• People whose doctors estimate they are expected to live at least 12 weeks.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard medical scale (ECOG performance status of 0 or 1).
• Men who are sexually active with a female partner who could become pregnant must use an effective form of contraception from the first day of treatment until 120 days after the last dose.
• Women who could become pregnant must use highly effective contraception throughout the study and for 120 days after the last dose — acceptable methods include a combination of a hormonal method (such as the pill) and a barrier method (such as a condom with spermicide); periodic abstinence and withdrawal are not accepted.
• Women who could become pregnant must promptly inform their treating doctor if they become pregnant or suspect they are pregnant during the study.
• People whose blood counts, liver, kidney, and clotting function meet specific laboratory thresholds set by the trial (confirm exact values with trial site).
• People who have not had a heart attack in the past six months, and whose blood pressure and any other heart conditions are medically controlled.
• People who have never previously received any cancer treatment, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• People who are planning to have surgery after completing pre-operative chemotherapy.
• People who are willing to provide tumour tissue and blood samples at the start of the study and again at the time of surgery.
• People who are able and willing to sign a written informed consent form.

Who may not be able to join:

• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People who have another cancer that is still active or has required treatment within the past 5 years (some minor skin cancers that have been fully treated may still be eligible — confirm with trial site).
• People who currently have an active infection that requires treatment with medication throughout the body.
• People who have an active autoimmune disease (where the immune system attacks the body) that has needed systemic treatment in the past 2 years — though some specific conditions, such as thyroid conditions on a stable hormone dose, vitiligo, or skin conditions not requiring systemic treatment, may not be excluded (confirm with trial site).
• People who have used corticosteroid medicines (such as prednisone at doses above 10 mg per day) or other immune-suppressing medications within the 14 days before starting the study — routine hormone replacement therapies are generally allowed (confirm with trial site).
• People who have a known history of a primary immune system deficiency condition.
• People who have received a live vaccine or certain immune-stimulating medicines (such as interferon or interleukin) within 30 days before the first dose.
• People who have a known history of active tuberculosis.
• People who have previously had an organ transplant or a stem cell transplant from another person.
• People who have a known severe allergy to any of the study drugs (sintilimab, apatinib, or the chemotherapy agents used in this trial).
• People with significant heart or blood vessel conditions, including serious heart rhythm problems, poor heart pumping function, recent stroke, or blood clot events (confirm specific details with trial site).
• People who are already taking part in another interventional clinical trial.
• People who have previously received any cancer treatment, including chemotherapy, radiotherapy, or targeted therapy.
• People who have previously received certain types of immunotherapy that work on specific immune system pathways (such as anti-PD-1 or anti-PD-L1 drugs).
• People whose tumour tests positive for HER-2.
• People who are unable to provide tumour tissue and blood samples.
• People who are pregnant or breastfeeding, or who plan to become pregnant within 5 months of the study ending.
• Women who could become pregnant must have a blood pregnancy test within 7 days before starting the study.

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