RecruitingPhase 2NCT07006077

Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer

A Phase II Trial to Evaluate the Efficacy of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Patients With Advanced Pancreatic Tumors


Sponsor

Hangzhou Converd Co., Ltd.

Enrollment

12 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main goal of this clinical trial is to preliminary evaluate the efficacy of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced pancreatic cancer.And the secondary purpose is to evaluate the safety of hV01.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of treatment for advanced pancreatic cancer — an oncolytic vaccinia virus (a modified virus that infects and kills cancer cells) that also expresses a protein called IL-21 to boost the immune response. The virus is injected directly into the tumor using an endoscope. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced pancreatic cancer confirmed by biopsy that has not responded to standard treatments - You have at least one tumor larger than 1.5 cm that can be injected (directly or via endoscopy) - Your overall health is good (ECOG 0–1) - Your blood counts, liver, and kidney function meet required levels **You may NOT be eligible if...** - You have not yet tried standard treatments for pancreatic cancer - You have poor overall health (ECOG 2 or above) - Your tumor cannot be safely injected - You are pregnant or breastfeeding - Your organ function does not meet study thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRecombinant human IL-21-expressing oncolytic vaccinia virus injection

hV01 is a recombinant vaccinia virus with deletions of the viral thymidine kinase (TK) and viral growth factor (VGF) genes and insertion of the human IL-21 gene.


Locations(1)

Affiliated Hangzhou First People's Hospital,School of Medicine,Westlake University

Hangzhou, Zhejiang, China

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NCT07006077


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