This study aims to evaluate the efficacy and safety of neoadjuvant sacituzumab tirumotecan (SKB264/MK-2870) combined with toripalimab in patients with locally advanced, resectable esophageal squamous cell carcinoma (ESCC). Eligible participants will receive 3 cycles of neoadjuvant treatment, followed by radical surgery. The primary endpoint is the pathologic complete response (pCR) rate.
Age >=18 years at the time of informed consent, either sex.
Histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma.
Judged by imaging and esophagoscopy as resectable and requiring neoadjuvant therapy, with clinical stage cT1-2N+M0 or T3-4N0-3M0 (stage II-IVA).
No prior antitumor therapy for esophageal squamous cell carcinoma.
Any prior antitumor therapy for the currently diagnosed esophageal squamous cell carcinoma.
History of other malignancies within 5 years (except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma in situ of the cervix).
Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose or during the study.
Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disease that interferes with or delays corneal healing.
Single group
Sacituzumab tirumotecan
Drug4 mg/kg administered intravenously on day 1 of each 14-day cycle for 3 cycles. Premedication is required before each infusion to prevent infusion-related reactions.
Toripalimab
Drug3 mg/kg administered intravenously on day 1 of each 14-day cycle for 3 cycles. When given on the same day, toripalimab is infused first, followed by sacituzumab tirumotecan after an interval of at least 30 minutes.
Pathologic complete response (pCR) rate
The proportion of participants with no residual viable tumor cells in the resected primary tumor and regional lymph nodes (ypT0N0) after neoadjuvant therapy, as assessed by central pathologic review.
Major pathologic response (MPR) rate
The proportion of participants with 10 percent or fewer viable tumor cells remaining in the resected primary tumor and regional lymph nodes after neoadjuvant therapy.
Objective response rate (ORR) per RECIST v1.1
The proportion of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1.
Event-free survival (EFS)
Time from the first dose to any of the following events: any disease progression that precludes surgery, postoperative disease progression or recurrence, or death from any cause, whichever occurs first, as assessed by the investigator according to RECIST v1.1.
Overall survival (OS)
Time from the first dose to death from any cause.
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