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Oncolytic Virus in Esophageal Squamous Cell Carcinoma
Sponsor: Sichuan University
Summary
This clinical trial is designed to evaluate the preliminary efficacy and safety of an oncolytic virus combined with chemotherapy and an immune checkpoint inhibitor in patients with initially unresectable, locally advanced esophageal squamous cell carcinoma (ESCC). The primary endpoints are safety, surgical conversion rate and event-free survival (EFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), and quality of life (QoL). Exploratory endpoints include biomarker analyses such as single-cell sequencing.
Official title: Oncolytic Virus Combined With Chemotherapy and Immune Checkpoint Inhibitors in Patients With Initially Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma:An Open-label, Single-arm Phase II Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-08-01
Completion Date
2027-09-01
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
Oncolytic Virus: Administered via intratumoral injection (metastatic lesions in the neck or supraclavicular lymph nodes) once every 3 weeks, for a total of two to four doses.
Oncolytic Virus: Administered via intratumoral injection(metastatic lesions in the neck or supraclavicular lymph nodes) once every 3 weeks, for a total of two to four doses, or until disease progression, the occurrence of unacceptable toxicity, or death from any cause, whichever occurs first. Chemotherapy + Immune Checkpoint Inhibitor (ICI): Administered via intravenous infusion once every 3 weeks.
Oncolytic Virus: Administered via intratumoral injection (primary lesions) once every 3 weeks, for a total of two to four doses.
Oncolytic Virus: Administered via intratumoral injection (primary lesions) once every 3 weeks, for a total of two to four doses, , or until disease progression, the occurrence of unacceptable toxicity, or death from any cause, whichever occurs first. Chemotherapy + Immune Checkpoint Inhibitor (ICI): Administered via intravenous infusion once every 3 weeks.
Locations (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, China