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 willing to take part and have signed a consent form agreeing to participate
• Adults aged 18 or older, of any gender
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and food pipe (gastroesophageal junction adenocarcinoma), confirmed by a tissue sample test
• People whose cancer has reached a certain stage involving nearby lymph nodes but has not spread to distant parts of the body (confirm with trial site for staging details)
• People whose doctors expect that a major surgery to remove all visible cancer (called R0 resection) is possible, and who have not previously received any cancer treatment for this type of cancer
• People whose cancer shows a certain level of HER2 protein (rated 1+, 2+, or 3+ on a standard test)
• People who are generally well enough to carry out normal daily activities, with a performance score of 0 or 1 on a standard medical scale
• People whose heart is pumping well, with a heart function measurement of 50% or above
• People whose recent blood test results (taken within 7 days before starting the study) show that bone marrow, liver, kidney, and blood clotting function are all within acceptable ranges, as determined by the trial centre
• Female participants who are surgically sterilised, past menopause, or who agree to use at least one medically accepted form of contraception for 7 days before and 6 months after treatment, are not breastfeeding, and have a negative pregnancy blood test within 7 days before joining; male participants who agree to use at least one medically accepted form of contraception for 7 days before and 6 months after treatment
• People who are able to understand and are willing to follow all trial procedures and follow-up requirements

Who may not be able to join:

• People who have previously received any cancer treatment for stomach or gastroesophageal junction cancer, including chemotherapy, radiation, targeted therapy, immunotherapy, or certain herbal medicines with anti-cancer properties used within 2 weeks before screening
• People whose doctors believe radiation therapy to the target cancer area will be needed during the treatment period around surgery
• People who had major surgery within 4 weeks before starting the study and have not fully recovered
• People who have had active stomach or intestinal bleeding, or are at high risk of bleeding, within 2 weeks before screening
• People who have had a hole or abnormal opening (perforation or fistula) in their digestive tract within 6 months before screening
• People with a blockage in the upper digestive tract, or a condition affecting how the gut absorbs medication, that could interfere with how the study drug capecitabine is absorbed
• People with significant nerve damage in the hands or feet rated at grade 2 or higher on a standard medical scale
• People who test positive for active Hepatitis B virus, active Hepatitis C virus, or HIV
• People who have received a live vaccine within 4 weeks before screening, or who plan to receive any vaccine (other than a COVID-19 vaccine) during the study
• People with moderate to severe heart failure (rated grade 3 or higher on a standard cardiology scale)
• People who have had cardiac chest pain restricting daily activities within 28 days before screening, or who have had a serious blood clot, stroke, or heart attack within 6 months before starting the study (with some specific exceptions — confirm with trial site)
• People who have an active or serious infection currently requiring treatment, such as active tuberculosis
• People with ongoing unstable health conditions such as uncontrolled diabetes, uncontrolled high blood pressure, or cirrhosis of the liver, as assessed by the investigators
• People with a history of lung disease requiring treatment that could affect surgery, such as scarring of the lung tissue or acute lung disease
• People who have had an active autoimmune disease requiring ongoing systemic medical treatment within the past 2 years, or who have taken steroid medicines above a certain dose within 14 days before screening (certain replacement hormone therapies are allowed — confirm with trial site)
• People who have had another cancer within the past 5 years, unless it was fully treated and considered cured (certain low-risk cancers such as early-stage thyroid cancer or skin cancer treated with surgery may be exceptions — confirm with trial site)
• People who have previously received a bone marrow or stem cell transplant from a donor, or a solid organ transplant
• People who are allergic to any of the medications used in this study
• People who are known to have a genetic deficiency of an enzyme called DPD (dipyrimidine dehydrogenase), which affects how certain chemotherapy drugs are broken down in the body
• People who have received immunotherapy or another experimental drug within 28 days before screening
• People who are pregnant or breastfeeding
• People who have any other health condition, abnormal test result, or other concern that the investigators consider would make participation unsafe or affect the study results

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