Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy
This trial is examining whether atezolizumab can improve disease-free survival rates in colorectal cancer patients who cannot receive standard oxaliplatin chemotherapy. The study is being conducted in Germany and is expected to conclude by February 2025.
Inclusion criteria: Participants must be 18 years or older and provide written informed consent. They must have a confirmed diagnosis of adenocarcinoma in the colon or rectum at high-risk stage II or stage III. The tumor must have been removed through successful surgery or be planned for removal. The cancer must be MSI-high or MMR-deficient, which are specific genetic characteristics. Patients must have an ECOG status of 0 to 2, indicating they can perform daily activities with varying levels of assistance. They must be unable to receive oxaliplatin-based chemotherapy or choose not to receive it. Adequate blood counts, liver enzymes, and kidney function are required. Those of childbearing potential must agree to use very effective birth control methods. Specific blood test results are required, with INR and PTT less than 1.5 times the normal limit within 7 days before joining.
Exclusion criteria: The study excludes patients who have a different type of cancer than the one being studied or have already received oxaliplatin-based chemotherapy. Those who have not had their tumor completely removed or do not plan removal, and those unwilling to follow study procedures cannot participate. Patients with other serious health conditions, active infections requiring treatment, or histories of certain heart, lung, liver, kidney, immune system, neurological, or psychiatric conditions are excluded. Pregnant or breastfeeding individuals, those participating in another clinical trial, or with known allergies to the study medication are not eligible. Patients with a history of substance abuse, those who have received live vaccines or had major surgery within certain time frames, or received certain medications before the study are also excluded.
Trial focus: The primary goal is to achieve improved disease-free survival rates at 3 years after treatment. The study includes a comparison with a placebo to evaluate atezolizumab's effectiveness. Upon joining, patients provide informed consent and undergo health assessments to confirm eligibility. Treatment begins with atezolizumab administered intravenously, with dosage and frequency determined by the study protocol. The treatment continues for a specified period, with regular monitoring and assessments to evaluate patient response. Throughout the study, scheduled visits and examinations monitor health status, treatment effects, disease-free survival, overall survival, and quality of life. The study lasts up to 12 months of treatment, with follow-up continuing until the study's conclusion.
Investigational drug: Atezolizumab is an immune checkpoint inhibitor that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By blocking this protein, the medication helps the immune system recognize and attack cancer cells. It is administered as an infusion directly into the bloodstream and is being tested as an adjuvant treatment, meaning it is given after primary treatment to help prevent cancer recurrence.
Germany