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 aged 18 to 75 years old (on the day they sign the consent form)
• People who have been diagnosed with stomach cancer or cancer of the junction between the stomach and oesophagus, confirmed by a tissue or cell test
• People whose stomach or gastroesophageal junction cancer has spread or cannot be surgically removed, and has gotten worse after receiving a first round of treatment (specifically, chemotherapy containing platinum and fluorouracil drugs, with or without immunotherapy)
• People whose scans show clear signs that their cancer has continued to grow during or after their most recent treatment
• People who have at least one measurable area of cancer that has not previously been treated with radiotherapy, or where there is clear evidence the cancer has grown after radiotherapy was completed
• People with a history of HER2-positive cancer must have previously received anti-HER2 treatment; people with unknown HER2 status must have this confirmed before joining the trial
• People whose major organs (such as liver, kidneys, and bone marrow) are functioning at an adequate level
• People with an ECOG performance score of 0 or 1, meaning they are either fully active or have only minor limitations in physical activity (confirm with trial site)
• People who are expected to live for at least 3 more months
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before being assigned to a treatment group, must agree to use reliable contraception from signing the consent form until 6 months after the last dose, and must not be breastfeeding during this time; men must also agree to use contraception and not donate sperm during this period
• People who fully understand the trial and are willing to sign a written consent form

Who may not be able to join:

• People who have had another type of cancer in the past 5 years, or currently have another active cancer (some fully cured early-stage skin, bladder, cervical, prostate, or breast cancers may still be eligible — confirm with trial site)
• People who have had uncontrolled fluid build-up in body cavities (such as around the lungs, abdomen, or heart) requiring frequent draining or medical treatment in the 14 days before joining
• People who have cancer that has spread to the brain or central nervous system
• People who have previously been treated with the chemotherapy drugs paclitaxel or docetaxel, unless their cancer came back more than one year after receiving those drugs as part of pre- or post-surgery treatment
• People whose cancer has a specific genetic marker called dMMR or MSI-H and who have never received immunotherapy are not eligible; people with unknown dMMR/MSI status must have this confirmed before joining
• People with a serious history of heart or stroke-related conditions, including: dangerous heart rhythm problems; a heart attack, heart failure, or stroke within the past 6 months; reduced heart pumping function; a specific heart electrical abnormality called long QT syndrome or a QTc interval over 480 milliseconds, or use of medications known to affect this; or poorly controlled high blood pressure (systolic at or above 160 mmHg and/or diastolic at or above 100 mmHg)
• People who have had a hole or abnormal opening in their digestive tract (perforation or fistula) in the 6 months before joining
• People with active hepatitis B, active hepatitis C, or HIV infection
• People who have needed antibiotics, antifungal, or antiviral treatment for a serious ongoing infection in the 14 days before joining (note: antiviral treatment for hepatitis is permitted)
• People who have been treated for tuberculosis in the past 2 years
• People who have had a bowel blockage or active inflammatory bowel disease in the 28 days before joining
• People who still have significant side effects from previous cancer treatments that have not improved to a mild level or resolved (with some exceptions such as hair loss, tiredness, or low appetite — confirm with trial site)
• People who have had major surgery or an invasive procedure within 28 days before joining, or who plan to have surgery to remove a tumour during the trial
• People who have received certain cancer treatments too recently before joining — including intravenous chemotherapy or biological therapies within 28 days, or oral chemotherapy, immunotherapy, hormone therapy, targeted therapy, or experimental treatments within 14 days (or 5 half-lives, whichever is shorter), or certain traditional Chinese medicines with anti-tumour indications within 14 days
• People who have taken strong medications known to interfere with a liver enzyme called CYP3A4 within the 14 days before joining (confirm with trial site)
• People who are allergic to or have a medical reason to avoid albumin or docetaxel
• People who are allergic to or have a medical reason to avoid steroid medications (glucocorticoids), including those with active stomach ulcers, severe high blood pressure, severe low potassium, or glaucoma
• People with psychiatric or neurological conditions that could affect their ability to follow the trial requirements, or people with a history of drug or alcohol dependence
• People who are currently participating in another clinical treatment trial (observational studies or trials where someone is only in the follow-up phase may still be eligible — confirm with trial site)
• People whom the trial investigators determine are not suitable for the study for other reasons

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