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 aged 18 or older on the day they sign the consent form, of any gender, who are able to understand and voluntarily sign the consent form.
• People who have been confirmed through tissue testing to have stomach cancer or colon cancer, with no sign of the cancer spreading to distant parts of the body.
• People whose ability to carry out daily activities falls within a certain range of fitness, rated 0 to 2 on a standard scale used by doctors (confirm with trial site for details).
• People whose cancer has been confirmed through laboratory testing to have a specific biological feature — either a DNA repair problem (called dMMR) or a high level of genetic instability (called MSI-H) — detected by standard tissue tests. Cases where these two results don't match will be reviewed by the trial team.
• People who are about to start, or have recently started, a 24-week course of a specific type of immune therapy (a PD-1 or PD-L1 antibody used alone), and who have not yet had their first check to see how the treatment is working.
• People who have tumor tissue samples available — either stored samples or freshly collected ones.
• People who are willing and able to follow all study visits, tests, and procedures as required by the trial.
• Women who could become pregnant, or men whose partners could become pregnant, who agree to use highly effective contraception starting 7 days before the first dose and continuing until 120 days after the last dose. Women who could become pregnant must also have a negative blood pregnancy test within 7 days before the first dose.
• For people being considered for the specific three-drug combination (Sintilimab, IBI310, and Lenvatinib): people whose blood counts and organ function (including kidney, liver, blood clotting, and urine protein levels) fall within acceptable ranges in the 7 days before starting treatment (confirm with trial site for specific values).

Who may not be able to join:

• People whose cancer has spread to distant parts of the body.
• People who have previously received a type of immune therapy that blocks a target called CTLA-4.
• People who have a lung condition called interstitial lung disease, or who have had a non-infectious type of lung inflammation that required steroid tablets or infusions to treat.
• People who have active autoimmune diseases (conditions where the immune system attacks the body) that require ongoing whole-body treatment, or who are at risk of these conditions returning — with some exceptions for milder or well-controlled conditions such as certain skin conditions, stable thyroid problems, stable type 1 diabetes, or childhood asthma that has fully resolved (confirm with trial site for the full list of exceptions).
• People who have had another cancer within the past 5 years — with exceptions for certain cancers that have been fully treated and cured, such as some skin cancers, non-invasive bladder cancer, certain low-risk prostate cancers, cervical or breast cancer that has not spread, or Lynch syndrome-related cases (confirm with trial site for details).
• People with certain serious or uncontrolled health conditions, including: active hepatitis B or C infection above certain levels; known HIV infection or AIDS; active tuberculosis; uncontrolled high blood pressure; certain heart conditions including heart failure, recent heart attack, or significant heart rhythm problems; or active bleeding that cannot be controlled with treatment.
• People who have had a bone marrow or organ transplant from another person.
• People who have had serious allergic or immune reactions to antibody-type medicines in the past.
• People who are pregnant or breastfeeding.
• For people being considered for the specific three-drug combination (Sintilimab, IBI310, and Lenvatinib): people who have had a bowel perforation or abnormal opening (fistula) in the 6 months before starting treatment (unless fully treated and recovered, as judged by the trial team); people who have had major surgery in the 28 days before starting treatment; people who have needed ongoing steroid or immune-suppressing medicines at certain doses in the 14 days before starting treatment (some short-term or inhaled steroid use may be allowed — confirm with trial site); or people whose side effects from previous cancer treatments have not yet recovered to an acceptable level.

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