Oncolytic virus plus chemotherapy and PD-1 inhibitor for locally advanced 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
This trial will try adding an oncolytic virus to chemotherapy and a PD‑1 blocker to see if it helps people with initially unresectable, locally advanced esophageal squamous cell carcinoma become operable and reduce cancer-related events.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sichuan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT07061704 on ClinicalTrials.gov |
What this trial studies
This is a phase 1/2, interventional trial giving intratumoral oncolytic virus together with standard chemotherapy and a PD‑1 immune checkpoint inhibitor in patients with initially unresectable, locally advanced esophageal squamous cell carcinoma. Treatment is delivered in 21‑day cycles for two to four cycles, with intratumoral injections to primary and/or accessible nodal lesions and routine clinical follow-up thereafter. Primary endpoints are safety, surgical conversion rate, and event‑free survival, with secondary endpoints including overall survival, objective response rate, and quality of life; exploratory biomarker work includes single‑cell sequencing of tumor tissue. All participants must undergo diagnostic endoscopy and baseline tissue sampling at West China Hospital, and study‑related costs are covered by the research budget.
Who should consider this trial
Good fit: Adults aged 18–80 with locally advanced esophageal squamous cell carcinoma who are treatment‑naïve for first‑line systemic therapy, have good organ function and performance status, and can provide fresh tumor tissue are ideal candidates.
Not a fit: Patients with poor nutritional status, high risk of gastrointestinal bleeding or esophageal perforation/fistula, prior antitumor chemo/radiotherapy/immunotherapy, uncontrolled severe medical conditions, or interstitial lung disease are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this approach could convert some patients from unresectable to resectable disease and improve event‑free and overall survival.
How similar studies have performed: Early‑phase studies of oncolytic viruses combined with checkpoint inhibitors have shown promise in other tumor types and limited data in esophageal cancer are encouraging but the approach remains experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chengdu, Sichuan
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Zhenyu Ding, MD
- Email: dingzhenyu@scu.edu.cn
- Phone: +862885422562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.