A Phase 2 interventional study of Toripalimab and Carboplatin + Paclitaxel in Esophageal Squamous Cell Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment
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 for OS and subsequent anticancer therapy for up to 3 years after ending study treatment.
Note: Toripalimab will be provided to the study by Coherus. Each site will obtain carboplatin and paclitaxel from commercial supply to administer as standard of care.
Adequate organ and bone marrow function resulted ≤ 28 days prior to first dose of protocol-indicated treatment:
Exclusion Criteria:
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 for OS and subsequent anticancer therapy for up to 3 years after ending study treatment. Note: Toripalimab will be provided to the study by Coherus. Each site will obtain carboplatin and paclitaxel from commercial supply to administer as standard of care.
Drug: Toripalimab · Drug: Carboplatin + Paclitaxel
Injection Q3W at 240mg doses
Also known as: Loqtorzi, toripalimab-tpzi
Carboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2
Also known as: CarboTaxol, PC
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.
Time frame: 4-11 weeks after completion of standard-of-care (SOC) dCRT.
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.
Time frame: from start of treatment until 1, 2, and 3yrs post treatment
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.
Time frame: from start of treatment until 2 and 3yrs post treatment
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).
Time frame: through study completion, an average of 1 year
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
Time frame: (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
Plan to share: No
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Esophageal Squamous Cell Carcinoma→
Vanderbilt-Ingram Cancer Center