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NOT YET RECRUITING
NCT07823270
PHASE2

Neoadjuvant Sacituzumab Tirumotecan Plus Toripalimab in Locally Advanced Esophageal Squamous Cell Carcinoma

Sponsor: Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Single-arm, Phase II Study of Neoadjuvant Sacituzumab Tirumotecan (SKB264/MK-2870) Combined With Toripalimab in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-10

Completion Date

2030-12

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DRUG

Sacituzumab tirumotecan

4 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.

DRUG

Toripalimab

3 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.

Locations (1)

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China