Phase II Study of Chemotherapy, Radiotherapy, and Durvalumab Immune Therapy for Advanced Esophageal Cancer

What this Trial Is About

Researchers are evaluating a combination treatment including stereotactic body radiotherapy and durvalumab added to a well-tolerated two-week chemotherapy and radiation regimen for adults with esophageal cancer that is locally advanced or has spread to other parts of the body. This Phase II trial aims to see if this combined approach can help the bodys immune system control cancer progression and improve swallowing difficulties. All participants will receive ten daily radiotherapy sessions to the primary esophageal tumor over two weeks alongside weekly intravenous chemotherapy with carboplatin and paclitaxel. Durvalumab, an immune therapy given intravenously, starts at the beginning of radiation and continues every four weeks for up to 24 months or until the cancer worsens. Participants with metastatic tumors will also receive three doses of stereotactic radiotherapy to metastases one month after initial treatment. Throughout the study, participants will undergo regular safety blood tests every two to four weeks and CT scans every six weeks up to week 24, then every 12 weeks until disease progression. They will also complete questionnaires about wellbeing and nutrition. Researchers will track progression-free survival, symptom relief, nutritional status, quality of life, response rates, toxicity, and survival over the study period, which may last up to two years.

A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study