Clinical trial · Interventional
Oncolytic Virus in Esophageal Squamous Cell Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 | — | UNRESOLVED |
| Oncolytic Virus: Administered via intratumoral injection (primary lesions) once every 3 weeks, for a total of two to four doses. | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oncolytic virus + chemotherapy + PD-1 inhibitor
- description
- Oncolytic Virus: Administered via intratumoral (metastatic lesions in the neck or supraclavicular lymph nodes) injection once every 3 weeks, for a total of two 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.
- interventionNames
- 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.
- type
- EXPERIMENTAL
- label
- Oncolytic virus in primary lesion + chemotherapy + PD-1 inhibitor
- description
- Oncolytic Virus: Administered via intratumoral (primary lesion of ESCC) injection once every 3 weeks, for a total of two 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available