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 been diagnosed with stage IV colorectal cancer through tissue testing, and who have had surgery with the aim of completely removing the cancer.
• The tissue sample removed during surgery must have been collected and sent to a specific laboratory (IRST IRCCS) and must meet all required quality standards set by that lab.
• People who have no signs of remaining cancer at the time of joining the trial, confirmed by a CT scan or MRI of the chest, abdomen, and pelvis taken within the 60 days before enrolment.
• People who have fully, or almost fully, recovered from the side effects of their surgery (confirm with trial site for exact recovery level required).
• People aged 18 years or older.
• People who are generally well enough to carry out daily activities, with little or no limitation due to illness (based on a standard medical scale called ECOG, scores 0 or 1).
• People whose blood counts and organ function results (including blood cells, liver, kidneys, and other markers) fall within acceptable ranges on blood tests — the trial site will check these specific values.
• People aged 70 or older must also have a heart pumping function of at least 55%, confirmed by a heart ultrasound (echocardiogram).
• People who are willing and able to use a highly effective form of contraception from the time of signing consent until three months after the end of the study. This applies to women who could become pregnant and to all men. Women who have been through menopause for at least two years, or who have had surgical sterilisation, are not required to meet this criterion. Complete abstinence may be acceptable if the treating investigator is satisfied it will be consistently followed.
• People who are willing and able to provide written consent to participate in the study.

Who may not be able to join:

• People who still have detectable cancer remaining after surgery.
• People whose colorectal cancer (originally stage I–III) came back within six months of finishing their primary treatment, or within six months of their last dose of chemotherapy if chemotherapy was given.
• People whose surgery took place more than 60 days before the planned enrolment date.
• People who have had another type of cancer in the past five years, with the exception of certain skin cancers or a specific type of cervical condition that was treated with curative surgery.
• People who have a history of immune system problems, whether present from birth or developed later, including people who have had an organ transplant.
• People whose blood tests show positive results for hepatitis B (in most cases), hepatitis C, HIV, or syphilis. These tests must have been done within 30 days before certain laboratory procedures. A positive result that only indicates previous hepatitis B vaccination is generally acceptable.
• People who are pregnant or currently breastfeeding.
• People who had chemotherapy with certain drugs (a fluoropyrimidine combined with oxaliplatin) before surgery, unless the treating doctor considers further chemotherapy unsuitable, or unless the person does not wish to continue that treatment after surgery.
• People who have taken part in another clinical trial using an experimental treatment within the 30 days before screening for this trial.
• People with an active inflammatory or autoimmune condition that requires, or is likely to require, treatment with steroids or other immune-modifying medicines during the study.
• People for whom the blood cell collection procedure used in this trial (called leukapheresis) would be medically unsuitable, as determined by the treating doctor or a specialist. People aged 70 or older must also be assessed by a heart specialist before this procedure.
• People for whom the specific immune therapy used in this trial (low-dose IL-2 given under the skin) would not be medically suitable, in the opinion of the treating doctor.
• People with serious ongoing illnesses that are not well controlled, including active infections, heart failure, chest pain at rest, irregular heart rhythms, or mental health or social circumstances that could affect safety or participation.
• People who do not wish to provide written informed consent.

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