Phase 2 Stomach 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 to 75 years old, of any gender.
• People with a good general health and activity level, as measured by a standard scoring tool (score of 0 or 1 on the ECOG scale, meaning fully active or able to carry out light work).
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and food pipe (confirmed by tissue or cell testing), and who have had major surgery to remove the cancer (a specific type of surgical procedure called D2 resection, with R0 or R1 clearance).
• People whose cancer has been classified as Stage III based on the current international staging system (8th edition AJCC).
• People with a life expectancy of more than 6 months.
• People whose main organs (blood, liver, kidneys) are working well enough to meet specific blood test results taken within 14 days before joining, including: red blood cell levels (haemoglobin ≥90 g/L), white blood cell levels (neutrophils ≥1.5×10⁹/L), and platelet levels (≥100×10⁹/L); liver function tests within acceptable ranges; and kidney function within acceptable ranges (confirm specific values with trial site).
• People with no obvious signs or symptoms of heart disease.
• People who show no signs of cancer returning, remaining, or spreading, confirmed by a full physical check-up and imaging scans (CT of the chest, and CT or MRI of the abdomen and pelvis) done within 28 days before joining.
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 7 days of being assigned to a treatment group, and must be willing to use a highly effective form of contraception throughout the study, for at least 120 days after the last dose of one study drug (penpulimab), and for at least 180 days after the last dose of chemotherapy.
• People who are willing to take part voluntarily and sign a consent form.
• People who are able to receive one cycle of a specific chemotherapy (XELOX) after a blood sample is taken for genetic testing, if needed while test results are being processed (confirm with trial site).

Who may not be able to join:

• People who have taken part in another drug clinical trial within the past four weeks.
• People who have difficulty taking medication by mouth, such as those who cannot swallow, have ongoing diarrhoea, or have a blockage in the bowel.
• People who have had a significant bleeding event (rated as serious, grade 3 or higher) within the four weeks before screening.
• People with known cancer spread to the brain or central nervous system, or a history of this. People where brain spread is suspected must have a CT or MRI scan to rule this out within 28 days before joining.
• People with high blood pressure that is not controlled by blood pressure medication (above 140/90 mmHg); people with a history of unstable chest pain (unstable angina); people newly diagnosed with chest pain conditions within 3 months before screening, or who have had a heart attack within 6 months before screening; people with certain heart rhythm problems or significant heart failure; or people with conditions that may prevent a study drug (anlotinib hydrochloride) from being properly absorbed by the body.
• People with wounds or bone fractures that have not healed over a long period of time.
• People where imaging scans show the cancer is very close to, or likely to grow into, major blood vessels in a way that could cause serious bleeding, as judged by the study doctor.
• People with blood clotting problems or a tendency to bleed abnormally; people taking blood-thinning medications such as warfarin (except low-dose warfarin of 1 mg daily or low-dose aspirin up to 100 mg daily used for prevention, which may be permitted — confirm with trial site).
• People who have had a serious blood clot or stroke-related event within the 6 months before screening, such as a stroke, mini-stroke (TIA), deep vein blood clot, or a blood clot in the lungs (except clots from previous chemotherapy that the study doctor has confirmed have resolved).
• People whose urine tests show significant protein levels confirmed by a 24-hour urine test showing more than 1.0 g of protein.
• People who have previously been treated with immunotherapy or targeted immune drugs.
• People with a history of immune system deficiency, other immune system disorders (inherited or acquired), or who have had an organ transplant.
• People with lung inflammation (such as infectious pneumonia, pneumonitis, or interstitial lung disease) that requires treatment with steroid medications.
• People with a history of serious chronic autoimmune conditions (such as lupus); inflammatory bowel conditions (such as ulcerative colitis or Crohn's disease); sarcoidosis or tuberculosis; or active hepatitis B, hepatitis C, or HIV infection. Note: People with hepatitis B virus levels below a certain threshold may still be considered (confirm with trial site).
• People who are allergic to monoclonal antibody treatments (a type of drug derived from human or mouse proteins).
• People with a history of substance misuse who are unable to stop, or people with serious mental health conditions.
• People with fluid build-up around the lungs or in the abdomen that is causing symptoms and requires medical treatment.
• People who are unlikely to follow the study plan or take medications as directed, or where not enough information is available to assess their safety or response to treatment.
• People with other serious health conditions that the study doctor believes would put the person at risk or make it difficult to complete the study.

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