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Page 8 of 15 Feng et al. Hepatoma Res 2021;7:3 I http://dx.doi.org/10.20517/2394-5079.2020.107

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Ad, SG7011 let7T Insertion of eight copies miRNA, let-7 HepG2, Hep3B, PLC/ Hep3B and SMMC- 5 × 10 PFU, IT [71]
of let-7 target sites (let7T) PRF/5, and Huh7 7721 xenografts
into the 39 untranslated BALB/c nude mice.
region of E1A
VV, JX-963 Deletion of TK and VGF, hGM-CSF None Immunocompetent, Various PFU, IV [72]
insertion of h GM-CSF orthotopic, NZW
rabbits VX2 tumor
model
MeV: measles vaccine virus; HSV: herpes simplex virus; Ad: Adenovirus; VV: vaccinia virus; NDV: newcastle disease virus; VSV:
vesicular stomatitis virus; IV: intravenous; IT: intratumoral; MOI: multiplicity of infection; PFU: plaque-forming units

Table 3. Clinical trials of oncolytic viral therapy for HCC
Clinical trials
identifier Status Active treatment n Primary end points or outcomes Ref.
NCT03071094 Active, not recruiting. JX-594; 30 DLTs, 4 weeks;
Phase 1 and 2 trials Nivolumab ORR, 6 months
NCT02562755 Active, not recruiting. JX-594; 600 OS, 53 months
Phase 3 trials Sorafenib
NCT00554372 Completed. Phase 2 trials JX-594 30 mRECIST v1.0 criterion; [81]
Choi criterion. 4 weeks
NCT01387555 Completed. Phase 2b trials JX-594; 129 OS, 21 months [82]
NCT00629759 Completed. JX-594 14 MTD, Safety evaluation throughout study participation [83]
Phase 1 trials
Most data were obtained from findings from www.clinicaltrials.gov using the search terms “hepatocellular carcinoma” and “oncolytic”.
JX-594: Recombinant vaccinia virus [Thymidine Kinase (TK)-deletion plus granulocyte-macrophage colony-stimulating factor (GM-
CSF)]. DLTs: dose limiting toxicities; ORR: overall response rate; OS: overall survival; MTD: maximum tolerable dose; mRECIST: modified
response evaluation criteria in solid tumors

Table 4. Clinical trials of therapeutic vaccines for HCC
Clinical trials Status Active treatment n Primary endpoints or outcomes Ref.
identifier
NCT04248569 Recruiting, Phase I DNAJB1-PRKACA peptide vaccine, 12 DLTs, 4 weeks; Fold change in
Nivolumab, Ipilimumab. interferon-producing DNAJB1-
PRKACA-specific CD8+ and CD4+
T cells, 12 weeks;
NCT03674073 Recruiting, Phase I Neoantigen Vaccines; Microwave Ablation 24 CTCAE v4.0, 1 year
NCT02409524 Completed, Phase II Individualized anti-cancer vaccine (CRCL- 15 OS, 12 weeks
AlloVax)
NCT01974661 Completed, Phase I COMBIG-DC vaccine (ilixadencel). 18 Registration of adverse events. 0.5 [84]
years
NCT03203005 Completed, Phase I/II IMA970A vaccine; CV8102 adjuvant; 22 Registration of adverse events, 2
Cyclophosphamide. years; Immunogenicity, 2 years
NCT00005629 Completed, Phase I/II Alpha-fetoprotein peptide-pulsed 6 Safety, 1 month
autologous dendritic cell vaccine
NCT00022334 Completed, Phase I/II Alpha-fetoprotein peptide-pulsed 33 DLT and MTD, 1 year
autologous dendritic cell vaccine
NCT04147078 Recruiting, Phase I Neoantigen-primed dendritic cell (DC) 80 DFS, 5 years
cell vaccine
NCT04251117 Recruiting, Phase, I/ Personalized neoantigen DNA vaccine 12 CTCAE v5.0, 2 years
IIa (GNOS-PV02) and plasmid-encoded Immunogenicity, 2 years
IL-12 (INO-9012) in combination with
pembrolizumab (MK-3475)
NCT02089919 Completed, Phase I/II Cancer stem cell vaccine 40 Adverse events. 3 months [85]
NCT00028496 Completed, Phase I Recombinant fowlpox-CEA(6D)/TRICOM 48 DLT and MTD, 56 days.
vaccine
NCT03942328 Recruiting, Phase I Autologous dendritic cells and Prevnar 26 Adverse events. 1 year
vaccine
NCT02232490 Recruiting, Phase III Hepcortespenlisimut-L (V5) therapeutic 120 Changes in plasma AFP, 3 months
vaccine
Most data were obtained from findings from www.clinicaltrials.gov using the search terms “hepatocellular carcinoma” and “vaccines”.
DLTs: dose limiting toxicities; CTCAE: common terminology criteria for adverse events; OS: overall survival; MTD: maximum tolerable
dose; DFS: disease-free survival