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RECRUITING
NCT07061704
PHASE1/PHASE2

Oncolytic Virus in Esophageal Squamous Cell Carcinoma

Sponsor: Sichuan University

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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