Phase 2 Colorectal 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:

• People aged 18 or older, of any gender
• People who are generally well enough to carry out daily activities with little or no limitation (as assessed by a standard medical scale called ECOG-WHO, with a score of 0 or 1)
• People who have been diagnosed with squamous cell cancer of the anus that has either spread to other parts of the body or has come back in a nearby area, confirmed by tissue testing
• People who have at least one measurable area of cancer visible on a CT scan or MRI, assessed using standard measurement rules
• People whose doctors consider them suitable for a specific chemotherapy combination called the mDCF regimen
• People who have had a CT scan within the 30 days before joining the trial
• People who have had a PET scan within the 30 days before joining the trial
• People whose doctors expect them to live for at least 12 months
• People whose blood test results, taken within 14 days before the first treatment dose, show that their blood cell counts, liver function, kidney function, and protein levels meet the required thresholds (confirm specific values with the trial site)
• People who have read and signed a consent form showing they understand and agree to take part
• People who are covered by the French social security system
• People who, in the opinion of the trial doctor, are able to follow the trial's requirements

Who may not be able to join:

• People living with HIV who have a CD4 cell count below 400 cells/mm³ (an HIV test is required before joining)
• People who have been diagnosed with another cancer within the past 2 years, unless it was a minor skin cancer or a low-grade cancer considered cured without systemic treatment
• People with a medical or psychiatric condition that the trial doctors consider would make participation unsafe or unsuitable
• People currently taking part in another clinical trial, or within an exclusion period from a previous trial
• People who have received any systemic cancer treatment within 4 weeks before the first dose of trial treatment
• People who have had radiation therapy to bone within 2 weeks, or any other radiation therapy within 4 weeks, before the first dose; or radioactive systemic treatment within 6 weeks; or who have ongoing significant complications from previous radiation
• People who are pregnant, breastfeeding, or who are able to have children and are unwilling to use adequate contraception during treatment and for 6 months after the last dose
• People who are under legal guardianship or court protection
• People who are unable to receive radiation therapy
• People with untreated or active brain or central nervous system (CNS) tumours, unless all known CNS lesions have been treated, there has been no sign of disease progression for at least 4 weeks, and steroid treatment has been stopped for at least 2 weeks
• People who have used certain blood cell-stimulating medications (such as G-CSF or erythroid stimulating agents) within 2 weeks before starting the trial (confirm specific rules about stable long-term use with the trial site)
• People who have received a live vaccine within 4 weeks before starting the trial
• People with elevated levels of certain heart-related proteins in their blood (cardiac troponin T or I more than twice the normal upper limit)
• People taking regular systemic steroid medication above a certain dose, or any immune-suppressing medication, within 7 days before the first dose (topical, inhaled, nasal, and eye steroids are generally permitted; confirm exceptions with the trial site)
• People with an active, known, or suspected autoimmune disease or a documented history of autoimmune disease (certain conditions such as vitiligo, stable type 1 diabetes, thyroid conditions on hormone replacement, or psoriasis not needing systemic treatment may be permitted — confirm with the trial site)
• People who have had a bone marrow or solid organ transplant from a donor
• People with a history of severe allergic reactions to similar antibody-based medicines, which in the opinion of the trial doctor may increase the risk of a serious reaction
• People with pre-existing nerve damage, hearing problems, or heart or breathing conditions that would prevent safe use of the chemotherapy drug cisplatin
• People with significant active heart disease or who have had a heart attack within the past 6 months
• People currently using or recently treated with a medicine called brivudine
• People with ongoing side effects from previous cancer treatment that are still rated above a minor level (grade greater than 1)
• People with a history or current diagnosis of interstitial lung disease or non-infectious lung inflammation
• People who have had major surgery within 28 days before starting treatment
• People with an active infection
• People with active Hepatitis B infection
• People with active Hepatitis C infection
• Women confirmed to be pregnant by a blood test within 72 hours before starting treatment
• Women who are physically capable of becoming pregnant and are not using highly effective contraception during treatment and for 7.5 months after stopping the study drug spartalizumab
• People with a complete or partial deficiency of an enzyme called DPD (dihydropyrimidine dehydrogenase), which affects how certain chemotherapy drugs are processed
• People with active inflammatory bowel disease (a history of the condition requires specialist review before joining — confirm with the trial site)

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