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NOT YET RECRUITING
NCT07836049
PHASE2

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

Sponsor: Vanderbilt-Ingram Cancer Center

View on ClinicalTrials.gov

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

Interventions

DRUG

Toripalimab

Injection Q3W at 240mg doses

DRUG

Carboplatin + Paclitaxel

Carboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States