Clinical Study of VG161 in Advanced Intrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCNBG-Virogin Biotech (Shanghai) Ltd.
About this trial
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 criteria
Qualifiers
1. Subjects must fully understand and give informed consent to this study before the trial, and voluntarily sign a written informed consent form.
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;
Disqualifiers
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 fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).
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;
Trial design
Treatments tested in this trial
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov