drugset / Trial / NCT07836049
PhII Study of Toripalimab Followed by Definitive CRT & Adjuvant Toripalimab in Locally Advanced ESCC
Phase 2
Not yet recruiting
20 enrolled
Vanderbilt-Ingram Cancer Center
Coherus Oncology, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase 2/window of opportunity study to determine the efficacy, by clinical complete response, and safety of induction toripalimab (PD-1 inhibitor) followed by definitive chemoradiotherapy (dCRT) and adjuvant toripalimab (up to one year) in patients with stage II - IVA ESCC. Tumor biopsies (tumor tissue, adjacent normal tissue), blood including ctDNA, and saliva will be obtained before, during, and after the induction phase. These tissues will be assessed for clinical and research associated markers and processes that may provide information regarding the role of toripalimab in tumor related processes.
Timeline
- Start
- 2026-12-31
- Primary completion
- 2030-12-31
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | 50 mg/m2 | — |