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PhII Study of Toripalimab Followed by Definitive CRT & Adjuvant Toripalimab in Locally Advanced ESCC
Sponsor: Vanderbilt-Ingram Cancer Center
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.
Official title: A Phase II Study of Induction/Window of Opportunity Toripalimab Followed by Definitive Chemoradiotherapy (CRT) and Adjuvant Toripalimab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-12-31
Completion Date
2031-12-31
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Toripalimab
Injection Q3W at 240mg doses
Carboplatin + Paclitaxel
Carboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2
Locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States