Oncolytic virus plus chemotherapy and PD-1 inhibitor for locally advanced esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Zhenyu Ding, MD
• Email: dingzhenyu@scu.edu.cn
• Phone: +862885422562

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.