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 to 75 years old, of any gender
• People diagnosed with stomach cancer (gastric adenocarcinoma) or cancer where the stomach meets the oesophagus (gastroesophageal junction adenocarcinoma), confirmed by a tissue or cell test
• People whose cancer has progressed after receiving either first-line chemotherapy alone, or first-line chemotherapy combined with immunotherapy; for one specific group, the best response to prior immunotherapy must have been complete response, partial response, or stable disease lasting at least 3 months
• People who have at least one tumour that can be measured on scans and has not been treated with radiation (or, if it was previously in a radiated area, progression has been confirmed)
• People with a good general health status, rated 0 or 1 on a standard activity scale (ECOG score), meaning fully active or able to carry out light work
• People expected to live at least 12 weeks
• People whose blood counts, liver function, and kidney function meet specific laboratory thresholds set by the trial (confirm exact values with the trial site)
• People who test negative for HER2 (a specific protein sometimes found on cancer cells)
• People willing to use medically approved contraception during treatment and for at least 6 months after the last dose of study medications — this applies to women who could become pregnant and to men whose partners could become pregnant
• People who are willing to participate voluntarily, sign a consent form, and attend follow-up appointments

Who may not be able to join:

• People who have had a hole or abnormal channel in their gastrointestinal tract (perforation or fistula) within the 6 months before starting the trial
• People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires repeated draining
• People with a known allergy to monoclonal antibodies, any ingredient in the study drug Carilizumab, or to albumin-bound paclitaxel (a type of chemotherapy)
• People who previously had serious side effects from immunotherapy and have been assessed as unsuitable to continue immunotherapy
• People who received another experimental drug within 4 weeks before starting this trial, or within 5 half-lives of that drug, whichever is longer (confirm with trial site)
• People currently enrolled in another interventional clinical trial
• People who received any anti-cancer treatment (including radiation, chemotherapy, immunotherapy, targeted therapy, or others) within 2 weeks before starting this trial
• People who needed high-dose steroid medicines (equivalent to more than 10 mg of prednisone per day) within 2 weeks before starting this trial, with some exceptions as assessed by the trial team
• People who received an anti-cancer vaccine or any live vaccine within 4 weeks before starting this trial
• People who had major surgery or a serious injury within 4 weeks before starting this trial
• People who have previously been treated with paclitaxel-based medicines
• People whose side effects from previous cancer treatments have not sufficiently resolved (confirm grading criteria with trial site)
• People with cancer that has spread to the brain or central nervous system
• People with active autoimmune diseases or a history of certain autoimmune conditions — some exceptions may apply for well-controlled conditions such as stable thyroid disease or type 1 diabetes (confirm with trial site)
• People with a history of immune deficiency, a positive HIV test, organ or bone marrow transplant history, or active hepatitis B or C
• People with significant uncontrolled heart problems, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, or poorly controlled abnormal heart rhythms
• People who had a severe infection within 4 weeks before starting the trial, or signs of active lung inflammation or infection within 2 weeks before starting
• People with a history of interstitial lung disease (scarring or inflammation of the lungs) — some exceptions may apply (confirm with trial site)
• People with active tuberculosis, or a history of tuberculosis within the past year, or a history of tuberculosis more than a year ago that was never properly treated
• People diagnosed with another cancer within the 5 years before starting the trial, with some exceptions for certain low-risk skin or cervical cancers that have been fully treated
• Women who are pregnant or breastfeeding
• People who, in the trial team's assessment, have other serious medical, mental health, or personal circumstances that could make participation unsafe or affect the collection of trial data

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