NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
Summary
The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, 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. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.
Timeline
- Start
- 2020-11-23
- Primary completion
- 2027-10-31
- Completion
- 2027-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HAFNIUM OXIDE | Other / unclassified | — | Other |
| Background | Capecitabine | Small molecule | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |