RecruitingPhase 2NCT06746480

Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma

A Single-Arm, Multicenter, Open-Label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of VG161 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma


Sponsor

CNBG-Virogin Biotech (Shanghai) Ltd.

Enrollment

33 participants

Start Date

Mar 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This trial is a single-agent, single-arm, multicenter, open-label design clinical trial for advanced intrahepatic cholangiocarcinoma who have failed standard therapy. To evaluate the efficacy of VG161 administered by ultrasound or CT-guided intratumoral injection in patients with advanced intrahepatic cholangiocarcinoma, with the primary outcome measure being objective response rate (ORR).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a cancer-killing virus called VG161 (an oncolytic herpes virus engineered to activate the immune system) injected directly into tumors in people with advanced intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) that has stopped responding to standard first-line treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced bile duct cancer inside the liver - Your cancer has progressed on or you could not tolerate at least one prior standard treatment - You have a measurable tumor that can be injected under ultrasound or CT guidance (longest diameter > 1.5 cm) - You have tested positive for herpes simplex virus type 1 (HSV-1) antibodies - Your ECOG performance status is 0 or 1 - Your organ function is adequate **You may NOT be eligible if...** - You have received anti-tumor treatment within the past 4 weeks - You have cancer spread to the brain or spine - You are in an active herpes outbreak (cold sores, genital herpes, etc.) - You have HIV, active hepatitis B or C - You have a history of serious heart disease in the past 6 months - You have active autoimmune disease that requires systemic treatment - 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

DRUGRecombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))

Intratumoral injection only. The dosing date is Days 1 through 3.


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06746480


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