RecruitingPhase 1NCT05698459

OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer

A Phase I, Open-label, Dose Escalation Study to Evaluate the Safety ,tolerance and Pharmacokinetics of OH2 Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer


Sponsor

Binhui Biopharmaceutical Co., Ltd.

Enrollment

12 participants

Start Date

May 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

An open-label dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of OH2 injection via transcatheter Intraarterial infusion in patients with advanced hepatocellular carcinoma


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether OH2 — an oncolytic virus (a virus engineered to infect and destroy cancer cells) — can be safely and effectively delivered directly into the liver's blood supply (via a catheter) in patients with advanced liver cancer that has not responded to standard treatment. **You may be eligible if...** - You are 18–75 years old with primary or metastatic liver cancer confirmed by biopsy - Your cancer has not responded to standard treatments or you are not eligible for them - Your liver function is adequate (Child-Pugh grade A or B) - You are in good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - You have active hepatitis B or C, HIV, or another uncontrolled infection - You have previously received oncolytic virus therapy - You have blood clotting problems or active bleeding - You are pregnant or breastfeeding 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

BIOLOGICALOH2 injection

OH2 injection administered by transcatheter Intraarterial infusion


Locations(1)

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT05698459


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