drugset / Trial / NCT07836049

PhII Study of Toripalimab Followed by Definitive CRT & Adjuvant Toripalimab in Locally Advanced ESCC

NCT07836049 ↗

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

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Background Carboplatin Small molecule — —
Background Paclitaxel Small molecule 50 mg/m2 —