A Clinical Study to Evaluate the Efficacy and Safety of VG2025 in Intrahepatic Cholangiocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VG2025.
- Who it may be relevant to
- Registry conditions: Intrahepatic Cholangiocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of VG2025 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma
Overview
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.
Interventions
- Drug VG2025
Recommended Phase II Dose, Intratumoral Injection, Q4W
Primary outcome measures
- ORR [Time frame: up to 36 months]
- DCR [Time frame: up to 36 months]
Secondary outcome measures (5)
- PFS [Time frame: up to 36 months]
- OS [Time frame: up to 36 months]
- Correlation between VG2025 efficacy and CEA levels [Time frame: up to 36 months]
- Immune-related indicators [Time frame: up to 36 months]
- Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: up to 36 months]
Eligibility criteria
Inclusion criteria
- Signed written informed consent form.
- Age 18 to 75 years (inclusive), male or female.
- Histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.
- Eligible participants of childbearing participants(male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.
Exclusion criteria
- Participants who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
- Participants who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
- 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.
- Other active uncontrolled infection.
- Known alcohol or drug dependence.
- Participants with mental disorders or poor compliance.
- Women who are pregnant or breastfeeding.
- Participants in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital，Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07522476 · VG201-C201