Oncolytic Virus in Esophageal Squamous Cell Carcinoma

Phase 2RecruitingNCT07061704

Sichuan University40 enrolled

Overview

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 r ate (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 or metastatic lymph nodes will be performed. All study-related costs will be covered by the research budget. 4.Participants will receive two to four 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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Cancer

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.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, 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.BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A. Age 18-80 years B. Diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) with/without 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

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

Treatment-related adverse effects (TRAEs)

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.

Time frame: Through study completion, an average of 1.5 year

Event Free Survival (EFS)

Time from the start of treatment to the first occurrence of any of the following events: disease progression or death from any cause.

Time frame: Through study completion, an average of 1.5 year

Secondary Outcomes

Overall Survival (OS)

Time from the start of treatment to death from any cause.

Time frame: 24months

Objective Response Rate （ORR）

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.

Time frame: 12months

Central Contacts

Zhenyu Ding, MD

CONTACT

+862885422562 dingzhenyu@scu.edu.cn

Data from ClinicalTrials.gov

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