Actively Recruiting
Study of VG161 Injection by Tumor Injection in Advanced Intrahepatic Cholangiocarcinoma A Single-Arm, Open-Label Phase IIa Clinical Trial Evaluating Efficacy and Safety
Led by CNBG-Virogin Biotech (Shanghai) Ltd. · Updated on 2024-12-24
33
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VG161, a recombinant human IL12/15/PDL1B oncolytic herpes simplex virus type 1 (HSV-1) injectable, in patients with advanced intrahepatic cholangiocarcinoma who have not responded to standard treatments. This single-arm, open-label, multicenter Phase IIa trial aims to assess the effectiveness of VG161 when given by ultrasound- or CT-guided injection directly into tumors. The main goal is to measure the objective response rate (ORR) over 27 months to determine if the treatment shows promising anti-tumor activity. The treatment involves intratumoral injections of VG161 on Days 1 through 3. The trial has two phases: initially, 20 participants are enrolled and evaluated for tumor response. If at least 5 out of 20 show a response, no further enrollment is needed. If responses are insufficient, enrollment continues to a total of 33 participants. Achieving 5 or more responses among 33 participants would indicate potential effectiveness, supporting further confirmatory studies. Participants will be assessed using CT scans to measure tumor size and response according to RECIST 1.1 criteria. Evaluations include monitoring safety, immune response, and overall health status. Eligibility requires positive HSV-1 antibody status, adequate organ function, and an expected survival of more than 3 months. The study tracks outcomes over 27 months to observe treatment efficacy and safety in advanced intrahepatic cholangiocarcinoma patients.
CONDITIONS
Official Title
Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma
- Previously received at least one systemic first-line therapy for advanced intrahepatic cholangiocarcinoma and failed or cannot tolerate it
- At least one measurable tumor lesion suitable for ultrasound or CT-guided injection with a baseline longest diameter greater than 1.5 cm
- Positive herpes simplex virus type I (HSV-1) antibody test (IgG or IgM)
- ECOG performance status of 0 or 1
- Expected survival time longer than 3 months
- Adequate organ function including blood counts, liver function, Child-Pugh class A-B, renal function, and coagulation parameters
- Use of reliable contraception for patients of childbearing potential during the trial and for 90 days after last dose
- Negative pregnancy test for females of childbearing potential within 7 days prior to enrollment
You will not qualify if you...
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor drugs within 4 weeks before first use of study drug (oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half-lives)
- Received transcatheter arterial chemoembolization (TACE) within 4 weeks before treatment
- Participated in other clinical trials with unapproved drugs within 4 weeks before treatment
- Major organ surgery or significant trauma within 4 weeks before first dose
- Received any vaccine within 4 weeks before first dose
- Use of systemic corticosteroids or immunosuppressive agents within 14 days before first dose, except certain topical or low-dose corticosteroids
- Unresolved adverse reactions from previous anti-tumor treatments above CTCAE grade 1 (except alopecia and non-safety risks)
- Presence of central nervous system or spinal cord metastases or compression
- Active herpes simplex virus infection or clinical symptoms such as oral or genital herpes
- Other uncontrolled active infections
- History of immunodeficiency including positive HIV or Treponema pallidum antibody tests
- Active chronic hepatitis B or C, except stable carriers or cured patients
- Serious cardiovascular disease or events within 6 months prior
- Active or relapsing autoimmune diseases except certain stable conditions
- Prior immunotherapy-related severe adverse events affecting safety
- Known alcohol or drug dependence
- Mental disorders or poor compliance
- Pregnant or breastfeeding women
- Other serious systemic diseases or conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
T
Tingbo Liang, MD.PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here