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 their written agreement to take part voluntarily
• People aged 18 to 75 years old at the time of joining
• People who are generally well enough to carry out daily activities with little or no limitation (as measured by a standard medical fitness scale called ECOG, scoring 0 or 1)
• People with a life expectancy of more than 2 years
• People whose cancer has been confirmed by laboratory testing to be a specific type of colon cancer called adenocarcinoma, without certain unusual cell types present
• People whose tumor testing shows that the cancer has a normal DNA repair system (called pMMR or MSS) — this is checked through tissue testing or genetic testing
• People whose cancer has been staged as T4 and/or has spread to nearby lymph nodes (Stage IIB–III) based on CT or MRI scans, according to a standard staging system
• People who have been assessed by a surgeon before joining and confirmed as suitable for an operation aimed at fully removing the cancer
• People who have not previously received any cancer treatment for their colon cancer, including chemotherapy, radiotherapy, immunotherapy, or targeted therapies
• People who agree to provide tumor tissue and blood samples for research during the study
• People whose blood, kidney, liver, and heart function results meet specific minimum standards set by the trial (confirm details with trial site)
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting treatment, and must use effective contraception from screening until 120 days after the last dose (periodic abstinence or rhythm methods are not accepted)
• People who are willing and able to attend all scheduled visits and follow the study plan

Who may not be able to join:

• People whose cancer appears to have spread to other parts of the body, or whose disease cannot be surgically removed
• People who have had another cancer (other than colorectal cancer) in the past 5 years, unless it was a minor skin cancer or early-stage cancer treated with local therapy only
• People who have taken part in another clinical trial or used an experimental treatment within the 4 weeks before starting this study
• People who currently have a blocked bowel, a hole in the bowel, or bowel bleeding that requires emergency surgery
• People who have more than one separate colorectal cancer at the same time
• People who have previously had radiotherapy to the pelvis or abdomen
• People who are unable to swallow tablets, or who have a condition that affects how the body absorbs food or medication through the gut
• People who have previously had any surgery, chemotherapy, radiotherapy, immunotherapy, or other anti-cancer treatment for their locally advanced colon cancer
• People who have received certain immune-boosting medications within 2 weeks before starting treatment, or certain herbal or traditional medicines with anti-cancer claims within 1 week before starting
• People who have an active autoimmune disease that has required ongoing medical treatment within the past 2 years (hormone replacement therapy for other conditions is not included in this)
• People who have a history of lung inflammation (not caused by infection) that required steroid treatment, or who currently have a chronic lung scarring condition
• People with a history of serious bleeding problems or clotting disorders, or who need long-term blood-thinning medication
• People with serious uncontrolled health conditions such as severe liver disease, kidney disease, uncontrolled diabetes or metabolism problems, severe stomach ulcers, or mental health or social conditions that would affect their ability to take part
• People with a history of heart muscle disease or dangerous heart rhythm problems
• People who have had serious heart problems such as unstable chest pain, heart failure, or blood vessel disease requiring hospital care in the 12 months before starting treatment
• People who have had oesophageal or stomach vein bleeding, serious ulcers, open wounds, bowel perforation, abdominal abscess, or acute gut bleeding in the 6 months before starting treatment
• People who have had a blood clot in an artery, a serious vein clot, a mini-stroke, a stroke, or a hypertensive crisis in the 6 months before starting treatment
• People who have had a flare-up of chronic obstructive lung disease (COPD) in the month before starting treatment
• People with poorly controlled high blood pressure despite taking medication (systolic at or above 160 mmHg or diastolic at or above 100 mmHg)
• People with active inflammatory bowel disease such as Crohn's disease or ulcerative colitis, or chronic diarrhoea
• People who have had a serious infection requiring hospital admission in the 4 weeks before starting treatment, or who have an active infection requiring antibiotic or antifungal treatment in the 10 days before starting (ongoing hepatitis B or C antiviral treatment is not included)
• People who have had major surgery or serious injury within 30 days before starting treatment, or minor surgery in the 3 days before starting (except for certain line insertions)
• People with a weakened immune system, a positive HIV test, or who are currently taking long-term steroids or other immune-suppressing medicines
• People with known active tuberculosis or active syphilis
• People who have previously received an organ transplant or bone marrow transplant from another person
• People with active hepatitis B where the virus level is above a certain threshold without treatment, or active hepatitis C (people with hepatitis B who are receiving antiviral treatment during the study may still be considered — confirm with trial site)
• People who have received a live vaccine within 30 days before starting treatment, or who plan to receive one during the study
• People with a known allergy to any ingredient in the study drugs, or a history of a severe allergic reaction to similar medications (monoclonal antibodies)
• People with a known history of serious psychiatric illness, or drug, alcohol, or substance misuse
• Women who are pregnant or breastfeeding
• People with any other disease, treatment history, or abnormal test result that the trial team determines could affect safety or results (confirm with trial site)
• People with serious illness not caused by their cancer, or cancer-related complications such as very high white blood cell counts, significant unintentional weight loss (more than 10% of body weight in the 3 months before screening), or a very low body mass index (BMI of 18 or below)

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