Vanderbilt-Ingram Cancer Center
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.
Intravenous (IV) toripalimab infusions on Day 1 of each 21-day treatment cycle for 2 doses prior to dCRT followed by adjuvant toripalimab for up to 1 year. No toripalimab will be given during SOC dCRT. After dCRT, all patients can progress to adjuvant toripalimab or resection followed by adjuvant toripalimab. After adjuvant toripalimab, routine surveillance will involve serial esophagogastroduodenoscopies (EGDs) and imaging. Treatment will continue for up to an additional year with adjuvant toripalimab infusions, until disease progression, or intolerable toxicity. Patients will be followed f…
Inclusion Criteria: 1. Signed and dated written informed consent. 2. Age ≥ 18 years the day of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. 4. Previously untreated, resectable, histologically confirmed stage II-IVA esophageal squamous cell carcinoma according to the 8th TNM staging system of the American Joint Committee on Cancer. 5. Has provided archival or newly obtained core or excisional biopsy tissue (fine needle aspirate \[FNA\] is not adequate) of a tumor lesion for local standard of care biomarker analysis. Repeat samples may be r…
Injection Q3W at 240mg doses
Carboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2
Arctuva estimate
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