Oncolytic Virus in Esophageal Squamous Cell Carcinoma

Not Applicable

Recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT07061704
• Lead Sponsor: Sichuan University

Brief 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 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.

Detailed Description

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 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.\*\*Participant Procedures\*\*:

1.All participants must undergo diagnostic endoscopy at West China Hospital to confirm eligibility. 2.Participants will undergo eligibility assessments. Once eligibility is confirmed, written informed consent will be obtained. 3.Single-cell sequencing of primary tumors and metastatic lymph nodes will be performed. All study-related costs will be covered by the research budget. 4.Participants will receive two cycles of the investigational treatment regimen (oncolytic virus + chemotherapy + PD-1 inhibitor), with each cycle lasting 21 days. Upon completion, patients will enter routine follow-up with healthcare professionals to monitor long-term safety and health status.

Study Timeline

• Study First Submitted: 2025-06-29
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• A. Age 18-80 years B. Diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) accompanied by cervical lymph node metastases.

C. Ability to provide fresh tumor tissue samples (baseline) D. Normal major organ function E. Performance status (PS) score ≤ 1 F. Patients of childbearing potential must use contraception G. Voluntary participation with signed informed consent H. Able to comply with the study protocol, follow-up schedule, and other protocol requirements.

Exclusion Criteria

• A. Received prior antitumor chemotherapy, radiotherapy, or immunotherapy before the first-line treatment.

B. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation C. Poor nutritional status D. Immune-related adverse events during prior radical treatment, such as Grade ≥3 pneumonitis, myocarditis, etc.

E. Signs and symptoms of interstitial diseases F. Presence of any severe and/or uncontrolled medical conditions G. Presence of concurrent malignancies H. Presence of other autoimmune diseases, or prolonged use of immunosuppressants or steroids I. Difficulty in patient communication or inability to comply with long-term follow-up J. Other conditions deemed unsuitable by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Event Free Survival (EFS)	Through study completion, an average of 1.5 year	Time from the start of treatment to the first occurrence of any of the following events: disease progression or death from any cause.
Treatment-related adverse effects (TRAEs)	Through study completion, an average of 1.5 year	This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	24months	Time from the start of treatment to death from any cause.
Objective Response Rate （ORR）	12months	The Objective Response Rate (ORR) is defined as the proportion of patients with complete response (CR) or partial response (PR), as assessed by RECIST 1.1.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chendu, Sichuan, China

West China Hospital of Sichuan University

🇨🇳Chendu, Sichuan, China

Zhenyu Ding, MD

Contact

+862885422562

dingzhenyu@scu.edu.cn