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A Response-Guided Neoadjuvant Treatment Approach for Treating Stage Ib-III Stomach or Gastroesophageal Junction Cancer, RANT-GC Trial

Trial Status: active

This phase I trial tests the safety and feasibility of a response-guided treatment approach before surgery (neoadjuvant treatment) for treating patients with stage IB - III adenocarcinoma of the stomach or gastroesophageal junction that has spread to nearby tissue or lymph nodes (locally advanced). Response-guided treatment is an approach in which treatment is adjusted based on how the tumor is responding during the study. Patients in this study receive different chemotherapy regimens (with or without immunotherapy drugs) prior to surgery, depending on how their tumor responds to treatment. Chemotherapy drugs, such as leucovorin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell’s deoxyribonucleic acid (DNA) and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by body's immune system. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers emtansine to kill them. A response-guided treatment approach using different chemotherapeutic and immunotherapeutic regimens before surgery may be a safe and feasible treatment option for patients with locally advanced stomach or gastroesophageal junction cancer.