OncoMatch/Clinical Trials/NCT04806464
Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer
Is NCT04806464 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 for primary liver cancer.
Treatment: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 — VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This phase I study will be conducted in HSV-seropositive subjects with advanced primary liver cancer that are refractory to conventional therapies. This is an open label study and it's divided into two parts. Part 1: This part is ascending dose design to determine the safety and tolerability of VG161 and find recommended dose of VG161. Part 2: This part is extended dose design to determine the effectiveness of VG161.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapies
refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists
Cannot have received: anti-tumor therapies (chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy)
Exception: oral fluorouracil analogues and small molecule targeted drugs: 2 weeks prior to first dose or within 5 half-lives (whichever longer)
prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation
Cannot have received: transcatheter arterial chemoembolization
Transcatheter arterial chemoembolization(TACE) within 4 weeks of study treatment initiation
Cannot have received: investigational agents
Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation
Lab requirements
Blood counts
ANC≥1.5×10^9/L, PLT≥75×10^9/L, Hb≥85g/L
Kidney function
Serum creatinine≤1.5×ULN, and creatinine clearance≥45 ml/min (Cockcroft-Gault)
Liver function
Total Serum bilirubin (TBIL)≤1.5×ULN, ALT≤5×ULN, AST≤5×ULN; Child-Pugh A-B level
Cardiac function
QTc interval >480 ms, LVEF <50%, NYHA cardiac function grade≥II, acute coronary syndrome, CHF, stroke or other cardiovascular events of III grade or above within 6 months, uncontrolled hypertension
Required organ function: ... Hematology blood (no blood transfusion or colony stimulating factor treatment within 14 days): absolute neutrophil count (ANC)≥1.5×10^9L, platelets (PLT)≥75×10^9L, hemoglobin (Hb)≥85g/L; 2) Liver function: Total Serum bilirubin (TBIL)≤1.5×ULN (the upper limit of the reference range), Alanine aminotransferase (ALT)≤5×ULN, aspartate aminotransferase (AST)≤5×ULN; 3)Child-Pugh A-B level; 4) Renal function: Serum creatinine≤1.5×ULN, and creatinine clearance≥45 ml/min (calculated per Cockcroft-Gault formula); 5) Coagulation function: activated partial thromboplastin time (APTT)≤1.5×ULN, prothrombin time(PT) ≤1.5×ULN, international standardized ratio (INR)≤1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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