Oesophageal squamous cell carcinoma metastatic Trials in Disease

Study on the Safety and Effects of Durvalumab and Tremelimumab with Radiotherapy for Patients with Metastatic Squamous Cell Carcinoma

This trial is studying whether combining two immune system-boosting medications with targeted radiation therapy is safe and effective for treating metastatic squamous cell carcinoma. This type of cancer can occur in various parts of the body, including the esophagus, head and neck, lungs, and other areas.

Main Focus and Goal: The study aims to evaluate the safety and effectiveness of combining Durvalumab and Tremelimumab with stereotactic body radiotherapy (SBRT), a precise form of radiation treatment. The trial is conducted in two phases: the first focuses on safety, while the second examines how well the treatment works in reducing cancer in areas that do not receive radiation directly. Researchers will use imaging tests like CT scans to monitor how tumors respond to treatment and track any side effects that may occur.

Investigational Drugs: The trial uses two main medications. Durvalumab works by blocking a protein called PD-L1, which normally prevents the immune system from attacking cancer cells. By blocking this protein, Durvalumab helps the immune system recognize and destroy cancer cells more effectively. Tremelimumab blocks another protein called CTLA-4, which can slow down the immune response. By inhibiting this protein, Tremelimumab enhances the immune system's ability to attack cancer cells. Both medications are given as intravenous infusions directly into the bloodstream. These are combined with SBRT, which delivers high doses of radiation with precision to cancer cells while minimizing damage to surrounding healthy tissue.

Who Can Join - Inclusion Criteria:

• Patients must be 18 years of age or older
• Have a confirmed diagnosis of metastatic squamous cell carcinoma in the esophagus or other specified areas, and have received previous treatment
• Have adequate organ function, including sufficient white blood cells (at least 1500 neutrophils per mm3), platelets (at least 100,000 per mm3), and hemoglobin levels greater than 9 g/dL
• Have liver enzyme levels (ALT and AST) no more than 2.5 times the normal limit, or 5 times if there are liver metastases
• Have kidney function with creatinine clearance greater than 40 mL/min
• Have at least one tumor that can be treated with radiation and another that will not be treated with radiation for comparison
• Have at least one tumor that can be biopsied both before and after treatment
• Have measurable tumors according to specific medical criteria (RECIST 1.1)
• Have a performance status of 0-1, meaning they are fully active or have some restrictions but can still do light work
• Female patients must either be unable to have children or have a negative pregnancy test before starting the study
• Patients capable of having children must use effective birth control during the study and for a period afterward

Who Cannot Join - Exclusion Criteria:

• Patients who have had another type of cancer in the past, except for certain treated skin cancers
• Those with an active infection requiring antibiotic treatment
• Those with a history of severe allergic reactions to similar medications
• Pregnant or breastfeeding women
• Patients with autoimmune diseases, where the body's immune system attacks its own healthy cells
• Those who have received a live vaccine within 30 days before starting the study
• Patients with serious heart conditions, such as heart failure or recent heart attack
• Those with uncontrolled high blood pressure
• Patients with a history of drug or alcohol abuse within the past year
• Those currently participating in another clinical trial
• Patients who have received radiation therapy in the area to be treated

Summary

There is currently one clinical trial available for patients with metastatic oesophageal squamous cell carcinoma, located in France. This trial is exploring an innovative combination approach that brings together two immunotherapy medications with precise radiation therapy. The study is particularly notable for investigating how these treatments work together to help the immune system fight cancer that has spread beyond its original location. The trial includes careful monitoring through imaging tests and biopsies to understand both the safety and effectiveness of this treatment combination. Patients interested in participating should discuss with their healthcare provider whether they meet the eligibility criteria and whether this trial might be appropriate for their specific situation.