Phase 2 Colorectal 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 have given written consent and chosen to take part voluntarily
• Adults aged 18 to 75 years old (men or women)
• People diagnosed with locally advanced rectal cancer (a specific type called adenocarcinoma), confirmed by a tissue test
• People whose pelvic MRI scan shows high-risk features, such as the cancer having grown through the bowel wall, spread into nearby blood vessels, spread to multiple nearby lymph nodes, involved the surrounding tissue lining, or spread to lymph nodes on the sides of the pelvis
• People whose tumour is located within 10 cm of the opening of the back passage
• People who are able to swallow tablets and capsules normally
• People with a good general performance level — able to carry out daily activities with little or no limitation (confirm with trial site)
• People who have not previously had any treatment for their rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
• People who are planned to have surgery after completing the full course of pre-surgery treatment
• People who have no medical reasons that would prevent them from having surgery
• People whose blood counts, liver function, kidney function, blood clotting, and heart pumping function are within acceptable ranges as measured by standard tests
• Women who could become pregnant must have a negative pregnancy blood test within 14 days before starting the trial, and must use effective contraception during the trial and for at least 6 months after the last dose; male participants whose partner could become pregnant must also use effective contraception during the trial and for 6 months after the last dose

Who may not be able to join:

• People with a known allergy to anti-angiogenesis drugs, monoclonal antibody components, capecitabine, oxaliplatin, or similar platinum-based drugs
• People who have recently taken immunosuppressive drugs or high-dose steroids (above a certain level) within 2 weeks before starting the trial, received a live vaccine within 4 weeks before starting, or had major surgery or serious injury within 4 weeks before starting
• People with an active autoimmune disease or a history of autoimmune conditions (such as lung inflammation, bowel inflammation, liver inflammation, or thyroid conditions — some exceptions may apply, confirm with trial site)
• People with a history of a weakened immune system, including HIV, other immune deficiency conditions, or those who have had an organ transplant or bone marrow transplant
• People with serious or uncontrolled heart conditions, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, significant uncontrolled heart rhythm problems, or poorly controlled high blood pressure
• People who had a serious infection (such as severe pneumonia or a blood infection requiring hospitalisation) within 4 weeks before starting, or who show signs of active infection within 14 days before starting
• People with active tuberculosis, or a history of tuberculosis within the past year, or older tuberculosis that was not properly treated
• People with active hepatitis B or hepatitis C infection (based on specific blood test levels)
• People who have or have had a second, separate cancer
• Women who are pregnant or breastfeeding
• People who have had a blood clot event within the past 6 months, such as a stroke, deep vein thrombosis, or pulmonary embolism
• People with a history of substance or drug misuse that has not resolved, or with a diagnosed mental health disorder
• People with any history of bleeding problems, or who are at high risk of bleeding
• People whose urine test shows a significant amount of protein in the urine, confirmed by a 24-hour urine test showing more than 1.0 g of protein
• People who, in the opinion of the trial investigator, have other serious conditions, personal circumstances, or other factors that could affect their safety or ability to complete the trial

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