Phase 3 Oesophageal Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older.
• People who have been diagnosed with HER2-positive stomach cancer (including cancer at the junction of the stomach and food pipe) that has spread locally, come back, or spread to other parts of the body, confirmed by a tissue or cell sample. HER2-positive is defined by specific laboratory test results (IHC 3+, or IHC 2+ with a positive ISH test).
• People whose cancer has stopped responding to at least one prior standard treatment containing trastuzumab (Herceptin) plus chemotherapy. Prior trastuzumab given before or after surgery may count as this first treatment if the cancer progressed during or within 6 months of finishing it.
• People who have at least one measurable or assessable tumour area visible on scans at the start of the trial, in an area that has not previously been treated with radiotherapy — or where there is clear evidence of significant growth after radiotherapy ended.
• People who are generally well enough to carry out light daily activities (a standard medical fitness score of 0 or 1, confirm with trial site).
• People with a life expectancy of at least 3 months.
• People whose blood, liver, kidney, and clotting function all meet specific minimum levels on laboratory tests (the trial site will check these results).
• People whose heart pumping function (left ventricular ejection fraction) is at least 50%, or within the normal range for the testing site, as measured by a heart scan.
• People who agree to use effective contraception throughout the study and for at least 6 months after the last dose. Women who could become pregnant must have a negative pregnancy blood test within 7 days before joining.
• People who are willing and able to follow the study schedule and procedures.

Who may not be able to join:

• People with brain metastases (cancer that has spread to the brain) that have not yet been treated. People with treated, stable brain metastases may be considered if specific stability conditions are met (confirm with trial site).
• People who have taken another experimental medication within 4 weeks before starting this trial.
• People who have received chemotherapy, small molecule drugs, immunotherapy, or certain Chinese herbal medicines with anti-cancer effects within 4 weeks (or 5 half-lives, whichever is shorter, but no less than 2 weeks) before starting the trial.
• People who had major surgery within 28 days before starting the trial, or who are expected to need major surgery during the trial.
• People who have previously received high cumulative doses of certain chemotherapy drugs called anthracyclines (such as doxorubicin), above specific thresholds (confirm with trial site).
• People who have previously received any anti-HER2 treatment other than trastuzumab (for example, other antibody-drug combinations, dual antibodies, or targeted small molecule drugs).
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 6 months of the final dose.
• People with a history of serious allergic reactions to protein-based medicines, or known allergy to any ingredient in the study drug KN026, or who have had a severe allergic reaction to trastuzumab.
• People who still have significant side effects from previous cancer treatments that have not returned to mild or baseline levels (except for hair loss, skin discolouration, or effects the trial doctor considers low risk).
• People with uncontrolled diarrhoea (grade 2 or above that does not improve within 48 hours of treatment).
• People with certain heart or cardiovascular conditions, including: uncontrolled high blood pressure despite medication; a history of heart failure with symptoms; significant drop in heart pumping function during or after prior anti-HER2 treatment; a heart attack within the last 6 months; chest pain or unstable angina within the last 3 months; serious heart rhythm problems requiring certain medications within the last 6 months; specific abnormal heart rhythm measurements on an ECG; or other heart conditions the doctor considers clinically significant.
• People with poorly controlled long-term conditions such as diabetes.
• People with serious active infections requiring ongoing antibiotic, antifungal, or antiviral treatment (including active tuberculosis).
• People who have taken higher-dose steroid tablets or injections within 2 weeks before starting the trial (inhaled or topical steroids, and short-term use for specific purposes, may be allowed — confirm with trial site).
• People with a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment.
• People with a history of immune system deficiency, including HIV-positive status, other inherited or acquired immune conditions, or a history of organ transplant.
• People with active hepatitis B or C virus infection meeting specific viral load thresholds, confirmed HIV, or confirmed syphilis (confirm with trial site for specific definitions).
• People who have had another cancer within the past 5 years, with certain exceptions such as specific skin cancers, non-invasive bladder cancer, certain low-risk prostate cancers that have been fully treated with no signs of return, or cervical or breast cancer in situ that has been fully treated with no signs of recurrence or spread.
• People who have needed drainage or diuretic treatment for fluid build-up (such as around the lungs, in the abdomen, or around the heart) within 2 weeks before starting the trial.
• People whose cancer is classified as mismatch repair deficient (dMMR) or highly microsatellite unstable (MSI-H) and who have not previously received a PD-1 or PD-L1 immunotherapy drug.
• People who have lost 5% or more of their body weight unintentionally in the month before starting the trial, even with nutritional support.
• People who are unable to tolerate or are unwilling to receive the chemotherapy required by the study.
• People the trial doctor considers unsuitable for any other medical or safety reason.

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