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RecruitingNCT07522476Updated Sep 22, 2026

A Clinical Study to Evaluate the Efficacy and Safety of VG2025 in Intrahepatic Cholangiocarcinoma

A Phase 2 interventional study of VG2025 in Intrahepatic Cholangiocarcinoma, sponsored by Virogin Biotech Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Virogin Biotech Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 229 studies in Cholangiocarcinoma with a site in China — 113 open to participants now, 124 under way, 12 of them phase 3. Cholangiocarcinoma · China.

Planned enrollment
139th of 190
30 · median 51
Started
2026
with 20 others
Phase 2
100 of 229
53 open now
Primary completion
2028-01
later than 92 of 123 live
Registered
207th of 229
by date

Among the 229 studies in Cholangiocarcinoma with a site in China, this one is the 139th largest by planned enrollment of the 190 interventional ones that give a count, is one of 21 that started in 2026, is one of 100 in phase 2, reaches primary completion later than 92 of the 123 other live ones, and was the 207th registered.

Cholangiocarcinoma

824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.

Browse Cholangiocarcinoma studies →

Open to participants now

113 of the 229 studies in Cholangiocarcinoma with a site in China are open now. Recruiting first, the newest first:

107 more — sign in →

All 113 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 211 Cholangiocarcinoma studies recruiting now, 141 (67%) set no upper age limit and 49 (23%) stop at 75 or younger; 10 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 229 studies in Cholangiocarcinoma with a site in China, or all of them as a file.
02

Study summary

VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent safety profiles with no dose-limiting toxicities (DLTs) observed and no maximum tolerated dose (MTD) identified. Moreover, it has shown preliminary efficacy in treating advanced tumors. Considering the actual clinical needs and the volume of intratumoral administration, a more appropriate recommended phase 2 dose (RP2D) level has been selected for the phase II clinical trial.

03

Conditions studied

  • Intrahepatic Cholangiocarcinoma

Browse trials for

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed written form.
  2. Age 18 to 75 years (inclusive), male or female.
  3. or cytologically confirmed advanced intrahepatic cholangiocarcinoma.
  4. Eligible participants of childbearing participants(male and female) must agree to use a reliable method of during the trial and for at least 90 days after dosing; females of must have a negative blood pregnancy test 7 days before enrollment.

Exclusion criteria

Exclusion Criteria:

  1. Participants who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
  2. Participants who underwent major organ surgery (excluding needle ) or had significant trauma 4 weeks before the first dose of the study drug.
  3. In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
  4. Other active uncontrolled infection.
  5. Known alcohol or drug dependence.
  6. Participants with mental disorders or poor compliance.
  7. Women who are pregnant or breastfeeding.
  8. Participants in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Single Arm

    VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W

    Drug: VG2025

Interventions

  • DrugVG2025

    Recommended Phase II Dose, Intratumoral Injection, Q4W

06

What researchers measure

Primary outcomes

  1. ORR

    Objective response rate (ORR)

    Time frame: up to 36 months

  2. DCR

    Disease control rate (DCR)

    Time frame: up to 36 months

Secondary outcomes

  1. PFS

    Progression-free survival (PFS)

    Time frame: up to 36 months

  2. OS

    Overall Survival (OS)

    Time frame: up to 36 months

  3. Correlation between VG2025 efficacy and CEA levels

    Preliminary analysis of the correlation between the efficacy of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels

    Time frame: up to 36 months

  4. Immune-related indicators

    Peripheral blood lymphocyte subsets, plasma cytokines, T cell immunity, and other immune-related indicators

    Time frame: up to 36 months

  5. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Safety will be evaluated according to CTCAE 6.0, including AEs/SAEs during the study, abnormalities or changes in 12-lead ECGs, and laboratory tests.

    Time frame: up to 36 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jan 2028, 16 months after the start.

Of 173 phase 2 interventional studies under Cholangiocarcinoma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 65. This study's planned 16 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2026
First posted
Apr 13, 2026
StartActual
Aug 25, 2026
Primary completionEst.
Jan 18, 2028
CompletionEst.
Nov 13, 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07522476
Lead sponsor
Virogin Biotech Ltd.
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
Aug 25, 2026
Primary completion
Jan 18, 2028 (estimated)
Completion
Nov 13, 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Yinan Shen
Contact
fysyn@163.com
+86-0571-87236666
Tingbo Liang, M.D.,PhD
principal investigator · First Affiliated Hospital of Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Oncolytic HSV-1 Expressing IL-12 and IL-15/IL-15-receptor Alpha VG2025

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