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.
Signed and dated written informed consent.
Age ≥ 18 years the day of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
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.
Locally advanced and incurable or metastatic disease is deemed incurable.
History of another malignancy within 3 years prior to screening, except for non-melanoma skin carcinoma, low-grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the cervix, or stage I uterine cancer.
Multiple primary esophageal cancers.
Previous radiotherapy of the thorax.
Single group
Toripalimab
DrugInjection Q3W at 240mg doses
Carboplatin + Paclitaxel
DrugCarboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2
To determine the clinical complete response rate to proportion of patients with complete clinical response (cCR) 4-12 weeks after completion of standard-of-care (SOC) dCRT.
Determine cCR score by achieving all of these:1 * No lesion, budding, or ulceration identified on esophagogastroduodenoscopy (EGD). * Bite-on-bite biopsies with no residual tumor. * EGD with endoscopic ultrasound (EUS) and fine needle aspiration (FNA) of suspicious lymph nodes (LNs) shows no residual tumor. If patients have suspicious LNs unable to be reached by FNA, they will not be classified as clinical complete responders.
To determine Disease-free survival (DFS
1, 2, and 3-year disease free survival rates defined as time from the start of treatment until disease recurrence, death from any cause, or the end of the study period if the patient does not experience recurrence.
To determine Overall survival (OS)
2 and 3-year overall survival rates defined as the time from start of treatment until death from any cause, or the end of the study period/last follow up.
To determine frequency of Adverse Events (AEs)
AEs will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v6).
To determine Quality of life (QOL) measurements
The EORTC-QLQ-C30 questionnaire will be administered prior to toripalimab induction (during screening), after induction (post-induction assessment), after dCRT (post-CRT assessment), at EOT visit, and then at coinciding follow-up visits for up to 3 years. Uses scores from 0 to 100 for each part; High functional score means good health; High symptom score means high pain or trouble
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Vanderbilt-Ingram Cancer Center
Lead sponsor
Coherus Oncology, Inc.
Collaborator
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