Anal cancer stage II Trials in Disease

Study on Durvalumab with Radiochemotherapy for Patients with Locally-Advanced Anal Cancer

This clinical trial is exploring whether adding an immunotherapy drug called durvalumab to the standard treatment can improve outcomes for patients with locally-advanced anal cancer, including stage II and stage III disease. The standard treatment combines chemotherapy and radiation therapy, known as radiochemotherapy.

Main inclusion criteria: Patients eligible for this trial must have a confirmed diagnosis of anal squamous cell carcinoma in stages IIB to IIIC. They must be at least 18 years old with a good performance status, meaning they can carry out normal daily activities with minimal difficulty. Important blood test requirements include having adequate white blood cell counts (leukocytes greater than 3.5 x 10⁹/l, neutrophils at least 1.5 x 10⁹/l), platelet counts of at least 100 x 10⁹/l, and hemoglobin levels of at least 9.0 g/dl. Liver and kidney function must be adequate, with specific enzyme levels and creatinine clearance above 40 mL/min. Patients must weigh more than 30 kg and have a life expectancy of more than 12 months. Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for 90 days afterward. The same birth control requirement applies to men who can father children. HIV-positive patients may participate if they are on effective antiretroviral therapy with an undetectable viral load.

Main exclusion criteria: Patients cannot participate if they have had another type of cancer in the past, with certain exceptions for specific skin cancers that have been successfully treated. The trial excludes those with uncontrolled or untreated serious infections, pregnant or breastfeeding women, and patients who have had an organ transplant. Those with serious heart, lung, liver, or kidney conditions are not eligible. Patients taking certain medications that affect the immune system or who have a history of severe allergic reactions to similar medications cannot join. Individuals with unstable mental health conditions, those participating in another clinical trial, or those with recent unhealed surgery are also excluded. A history of uncontrolled drug or alcohol abuse is an exclusion factor, as is the inability to follow study procedures.

Focus and goal: The primary goal of this trial is to determine whether adding durvalumab to standard radiochemotherapy can extend the time patients live without their cancer returning, known as disease-free survival. The study will randomly assign participants to either receive the standard treatment with durvalumab or the standard treatment alone (possibly with a placebo for comparison). Patients will undergo regular check-ups and tests, including MRI scans and proctoscopy procedures, to monitor their response to treatment. Approximately 26 weeks after starting treatment, patients will have a comprehensive assessment to see if they have achieved a complete clinical response. The study will also evaluate safety, treatment adherence, overall survival rates, and quality of life. Researchers will explore the use of different MRI techniques to predict and monitor treatment response. The trial is expected to continue until the end of 2026.

Investigational drug: Durvalumab is an immune checkpoint inhibitor that works by blocking a protein called PD-L1, which helps the body's immune system recognize and attack cancer cells more effectively. It is given as an intravenous infusion directly into the bloodstream at a concentration of 50 mg/mL. The standard radiochemotherapy includes radiation therapy combined with two chemotherapy drugs: mitomycin C and 5-fluorouracil, which work together to kill cancer cells and enhance the effects of radiation.