NCT07128693

A Single-center, Multicohort, Phase II Clinical Study Evaluating the Combination Therapy of Sacituzumab Tirumotecan in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of the combined treatment with Sacituzumab Tirumotecan in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sacituzumab Tirumotecan in combination with tislelizumab	Sacituzumab Tirumotecan 5mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Tislelizumab，200 mg, iv, d1, Q3W, until disease progression or intolerable toxicity.
DRUG	Sacituzumab Tirumotecan in combination with anlotinib	Sacituzumab Tirumotecan 5mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Anlotinib 12mg QD po d1-14，Q3W,until disease progression or intolerable toxicity.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-08-19
• Last updated: 2025-08-19