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New treatment option for Advanced Intrahepatic Cholangiocarcinoma
Official title Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT06746480
What this study is testing
What is Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))?
Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced intrahepatic cholangiocarcinoma.
Also referred to as VG161.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. people must fully understand and give informed consent to this study before the trial, and voluntarily sign a written informed consent form. 2\...
- Blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 109/L, PLT ≥ 75 × 109/L, Hb ≥ 85 g/L;
- Liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN;
- Child-Pugh A-B;
- Renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml/min (calculated according to Cockcroft-Gault formula);
You likely can't join if
- 1\. received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4...
- Ventricular arrhythmia requiring clinical intervention;
- QTc interval \> 480 ms;
- Acute coronary syndrome, congestive heart failure, stroke or other Grade III and above cardiovascular events within 6 months before the first use of...
- New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) \< 40%;
- Uncontrolled hypertension after treatment (judged by the investigator); 14. Patients with active, or have had and have the possibility of relapse of...
See the full eligibility criteria
- 1\. people must fully understand and give informed consent to this study before the trial, and voluntarily sign a written informed consent form. 2\. aged 18 to 75 years (inclusive), male or female. 3. patients with...
- Blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 109/L, PLT ≥ 75 × 109/L, Hb ≥ 85 g/L;
- Liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN;
- Child-Pugh A-B;
- Renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml/min (calculated according to Cockcroft-Gault formula);
- Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN; 10.Eligible patients of childbearing potential (men...
- 1\. received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral...
- Ventricular arrhythmia requiring clinical intervention;
- QTc interval \> 480 ms;
- Acute coronary syndrome, congestive heart failure, stroke or other Grade III and above cardiovascular events within 6 months before the first use of study drugs;
- New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) \< 40%;
- Uncontrolled hypertension after treatment (judged by the investigator); 14. Patients with active, or have had and have the possibility of relapse of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.