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 agreed to take part voluntarily, have signed a consent form, and are willing to attend follow-up appointments
• People aged 18 to 75 years (inclusive), of any gender
• People whose rectal cancer has been confirmed by tissue biopsy and MRI scan to be locally advanced (specifically, classified as cT3 or higher, or with cancer spread to nearby lymph nodes)
• People whose tumour, as confirmed by MRI, has its lower edge within 10 cm of the opening of the back passage
• People who have not previously received any anti-cancer treatment for their rectal cancer (traditional Chinese medicine treatments are an exception)
• People who are in good enough general health to be active and carry out light work (ECOG performance score of 0 or 1)
• People whose blood counts, liver, kidney, and clotting function meet specific levels required by the trial, tested within 2 weeks before joining — without the use of blood transfusions or growth factor medications to artificially improve those results (confirm specific values with trial site)
• Women who could become pregnant must agree to use reliable contraception or avoid heterosexual intercourse from signing the consent form until at least 6 months after the last dose, must have a negative blood pregnancy test within 7 days before starting treatment, and must not be breastfeeding
• Male participants whose partners could become pregnant must agree to use reliable contraception or avoid intercourse, and must not donate sperm, from signing the consent form until at least 6 months after the last dose; those with pregnant partners should use a condom

Who may not be able to join:

• People whose rectal cancer has come back after previous treatment
• People whose cancer has been assessed as unable to be surgically removed, or who are considered too unwell to undergo surgery
• People who have evidence — from examination or scans — of cancer that has spread to distant parts of the body, or to lymph nodes in the side walls of the pelvis
• People who have more than one area of colorectal cancer
• People who have evidence of a blocked or perforated bowel, or who are assessed as being at high risk of perforation or bleeding
• People for whom the treating doctor considers long-course radiotherapy to be unsuitable
• People who have had a stroke, mini-stroke (TIA), heart attack, or significant blood vessel disease within the 6 months before joining; or who have poorly controlled heart conditions such as unstable chest pain, moderate-to-severe heart failure, reduced heart pumping function, or serious irregular heart rhythms not controlled by medication
• People with a history of active tuberculosis in the lung detected by records or CT scan, including active tuberculosis within the past year, or a history of tuberculosis more than one year ago that was not properly treated
• People who have had major surgery (performed under general anaesthetic) within 3 months before starting the trial, or who have wounds that are not healing, active stomach ulcers, or untreated bone fractures
• People who have difficulty swallowing or other problems that would prevent them from taking oral medication
• People for whom an MRI scan is not safe or suitable (confirm specific contraindications with trial site)
• People with an active autoimmune disease or a significant history of autoimmune conditions (such as autoimmune hepatitis, certain lung, eye, bowel, or kidney conditions); some exceptions apply, including well-controlled thyroid conditions on replacement therapy, certain skin conditions not needing systemic treatment, insulin-controlled type 1 diabetes, and childhood asthma fully resolved in adulthood — confirm details with trial site
• People who have a weakened immune system, including those who test positive for HIV, have other immune deficiency conditions, or have had an organ transplant or bone marrow transplant from a donor
• People who have had a serious infection within 4 weeks before starting the trial (such as severe pneumonia or a blood infection requiring hospitalisation), or signs of active infection requiring antibiotic tablets or drips within 2 weeks before starting (preventive antibiotics are an exception)
• People with a current or past history of serious lung inflammation (such as interstitial lung disease or pneumonitis) that required steroid treatment, or other lung conditions that could interfere with monitoring for treatment-related lung side effects; people with active pneumonia on a chest CT scan, or severely reduced lung function
• People with active hepatitis B or active hepatitis C infection meeting specific viral load levels, or those with both hepatitis B and hepatitis C infection together (confirm specific values with trial site)
• People who have been diagnosed with another cancer within the 5 years before starting the trial; some exceptions may apply for certain fully treated skin cancers or early-stage cervical or breast cancers, but not for those who previously received immunotherapy, chemotherapy, targeted therapy, or radiation for those cancers — confirm with trial site
• People with a known allergy or sensitivity to any of the study drugs (pucotenlimab, oxaliplatin, or capecitabine) or their ingredients
• People who have taken immune-suppressing medications or steroid tablets at doses above a certain level within 14 days before starting the trial (some inhaled, topical, or low-dose hormone replacement steroids are permitted — confirm with trial site)
• People who have taken part in another clinical trial within 4 weeks before starting, or who have received an investigational drug or device within that period
• People with significantly abnormal sodium, potassium, or calcium blood levels within 2 weeks before starting that cannot be corrected with treatment
• People who have received a live vaccine within 28 days before starting, or who plan to receive one during treatment or within 60 days after the last dose
• Women who are pregnant or breastfeeding
• People who, in the treating doctor's judgement, have other factors that could affect the study results or their safety, such as alcohol or drug misuse, serious mental health conditions, severe abnormal test results, or significant personal or social circumstances

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