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Oncolytic Virus in Esophageal Squamous Cell Carcinoma

ConditionEsophageal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A. Age 18-80 years B. Diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) with/without cervical lymph node metastases.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Vaccine

    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/Vaccine

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Oncolytic virus + chemotherapy + PD-1 inhibitorExperimental treatment 1 intervention
Group B: Oncolytic virus in primary lesion + chemotherapy + PD-1 inhibitorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

Overall Survival (OS)

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

Time frame
24months
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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