Phase 1 Study Evaluating NBTXR3 Nanoparticles Activated by Radiation and Chemotherapy for Treatment of Esophageal Adenocarcinoma

What this Trial Is About

Researchers are evaluating NBTXR3 nanoparticles activated by radiation therapy combined with chemotherapy for treating patients with esophageal adenocarcinoma. This Phase I study aims to find the recommended dose and assess the safety of this combination treatment. NBTXR3 is designed to target and destroy cancer cells when activated by radiation, and chemotherapy drugs used work by stopping tumor growth in different ways. Participants receive a single dose of NBTXR3 injected directly into the tumor or nearby lymph nodes on day 1. Starting on day 15, they undergo intensity-modulated radiation therapy IMRT five days per week for six weeks. Concurrent chemotherapy regimens, chosen by the physician, include combinations of fluorouracil, oxaliplatin, capecitabine, docetaxel, paclitaxel, and carboplatin. This treatment continues unless the disease progresses or side effects become unacceptable. After completing treatment, participants are followed every three months for one year to monitor safety, tumor response, and survival outcomes. Researchers assess side effects, tumor shrinkage, local and distant disease progression, and overall survival. They also study how NBTXR3 behaves in the body, surgical outcomes if surgery follows treatment, and immune system markers related to response.

NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer