Table 2.
Summary of ongoing clinical trials for gene therapy for liver cancers.
| No | NCT Number | Types of Liver Tumors | Gene/Antigen | Types of Gene | Vectors or Cells | Intervention | Route of Administration | Phase | Current Status and Results | Ref. |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00003147 | HCC | p53 | Adenoviral Vector | Ad5CMV-p53 gene | Percutaneous injection | 1 | Terminated No results available | ||
| 2 | NCT01071941 | Primary Liver Cancers | Oncolytic Virus | Oncolytic Virus | Herpes simplex virus 1 | rRp450 | Hepatic arterial injection | 1 | Recruiting No results available Estimated Completion Date: July, 2020 | |
| Metastatic Liver Tumors | ||||||||||
| 3 | NCT00844623 | HCC | HSVtk | Suicide | Adenoviral vector | TK99UN (adenoviral vector containing TK) | Intratumoral injection | 1 | Completed Results partly reported. | [73,124] |
| 4 | NCT02202564 | HCC | HSVtk | Suicide | Adenoviral vector | LT ADV-TK ganciclovir | Intravenous infusion | 2 | Completed No results reported to date | |
| 5 | NCT02561546 | HCC | p53 | Tumor suppressor | Recombinant adenoviral vector | p53 gene therapy TAE | Hepatic arterial injection following TAE | 2 | Not yet recruiting | |
| 6 | NCT00300521 | HCC | HSVtk | Suicide | Adenoviral vector | ADV-TK | Intravenous infusion | 2 | Completed No results reported to date | |
| 7 | NCT00004178 | Primary Liver Cancers Metastatic Liver Tumors | CEA | Tumor-related Protein Coding | T Cells Modified with Chimeric Anti-CEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma | Therapeutic autologous lymphocytes | Intravenous infusion | 1 | Completed No results reported to date | |
| 8 | NCT03313596 | HCC | HSVtk | Suicide | Adenoviral vector | ADV-TK LT | Intravenous infusion | 3 | Recruiting No results available Estimated Completion Date: Dec, 2019 | |
| 9 | NCT03480152 | Primary Liver Cancers | mRNA containing epitopes from immunogenic neoantigens | Tumor-related Protein Coding | mRNA vaccine | NCI-4650, a mRNA-based, Personalized Cancer Vaccine | Intramuscular injection | 1/2 | Terminated Related results partly reported | [159,160,161] |
| Metastatic Liver Tumors | mRNA containing epitopes from immunogenic predicted neoantigens | |||||||||
| mRNA containing epitopes from immunogenic mutations in tumor suppressor or driver genes | ||||||||||
| 10 | NCT01967823 | HCC Metastatic Liver Tumors | NY-ESO-1 | Tumor-related Protein Coding | Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes | Anti-NY ESO-1 mTCR PBL Cyclophosphamide Fludarabine Aldesleukin | Intravenous infusion | 2 | Recruiting No results available Estimated Completion Date: July, 2028 | [162,163,164] |
| 11 | NCT02509169 | HCC | p53 | Tumor suppressor | Recombinant adenoviral vector | TAE plus P53 gene TAE | Hepatic arterial injection following TAE | 2 | Recruiting No results available | |
| 12 | NCT02932956 | Pediatric Primary Liver Cancers | GPC-3 | Tumor-related Protein Coding | CAR T cells | GAP T cells Cytoxan Fludara | 1 | Recruiting No results available Estimated Completion Date: Feb, 2037 | ||
| 13 | NCT00012155 | Metastatic Liver Tumors | Oncoytic Virus | Oncoytic Virus | oncolytic herpes simplex virus type-1(HSV-1) | NV1020, oncolytic herpes simplex virus type-1 (HSV-1) | Hepatic arterial injection | 1 | Completed Results partly reported | [74] |
| 14 | NCT00066404 | Metastatic Liver Tumors | Interferon-beta | Genetic Immunotherapy | Adenoviral vector | recombinant adenovirus-hIFN-beta | Intrapleural injection | 1 | Active, not recruiting Results partly reported | [165] |
| 15 | NCT00035919 | Metastatic Liver Tumors | Dominant Negative Cyclin G1 | Tumor suppressor | Retroviral Vector | Mx-dnG1 Retroviral Vector | Hepatic arterial infusion | 1/2 | Withdrawn | |
| 16 | NCT00005629 | Primary Liver Cancers Metastatic Liver Tumors | AFP | Tumor-related Protein Coding | AFP peptide | AFP gene hepatocellular carcinoma vaccine | Intradermal injection | 1/2 | Completed No results reported to date | |
| 17 | NCT02905188 | HCC | GPC-3 | Tumor-related Protein Coding | CAR T cells | GLYCAR T cells | Intravenous infusion | 1 | Recruiting No results available Estimated Completion Date: Oct, 2036 | |
| 18 | NCT00093548 | HCC | AFP, GM-CSF | Tumor-related Protein Coding | Adenoviral vector | Vaccination AFP plasmid DNA vaccine GM-CSF plasmid DNA hepatocellular carcinoma vaccine adjuvant | Intramuscular injection/Intradermal injection | 1/2 | Withdrawn | [92] |
| 19 | NCT01628640 | Primary Liver Cancers Metastatic Liver Tumors | Interferon-beta | Genetic Immunotherapy | Vesicular Stomatitis Virus | Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta | Intratumoral Injection | 1 | Active, not recruiting Estimated Completion Date: June, 2025 | |
| 20 | NCT03602079 | HCC CCC Metastatic Liver Tumors | HER-2 | Tumor-related Protein Coding | Antibody Drug Conjugate (ADC) | A166, an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells. | Intravenous infusion | 1/2 | Recruiting No results available Estimated Completion Date: May, 2021 | |
| 21 | NCT02416466 | Metastatic Liver Tumors | CEA | Tumor-related Protein Coding | CAR-T cells | anti-CEA CAR-T cells | Hepatic arterial infusion | 1 | Completed No results reported to date | |
| 22 | NCT02869217 | NY-ESO-1 Expressing Liver Cancers in HLA-A2 Positive Patients Metastatic Liver Tumors | NY-ESO-1 | Tumor-related Protein Coding | NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes | TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) Cyclophosphamide | Infusion | 1 | Recruiting No results available Estimated Completion Date: June, 2020 | |
| 23 | NCT01061840 | Primary Liver Cancers Metastatic Liver Tumors | rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid | Tumor-related Protein Coding | plasmid | Vaccination | Intradermal injection | 1 | Completed Results partly reported | [166,167] |
| 24 | NCT01437007 | Metastatic Liver Tumors from Colorectal, Pancreas, Gastric, Breast, and Ovarian Cancers | siRNA Against the PLK1 | Oncogene suppression | Lipid Nanoparticles | TKM-080301 | Hepatic arterial infusion | 1 | Completed Results partly reported | [53] |
| 25 | NCT03971747 | HCC | AFP | Tumor-related Protein Coding | T Cell | AFP Specific T Cell Receptor T Cells | Intravenous infusion | 1 | Not yet recruiting | |
| 26 | NCT02418988 | HCC | p53 | Tumor suppressor | Recombinant adenoviral vector | TACE plus rAd-p53 artery injection TACE | Injected into the embolization artery. | 2 | Recruiting No results available | |
| 27 | NCT02850536 | Metastatic Liver Tumors from Colorectal, Pancreas, Gastric, Breast, and Ovarian Cancers | CEA | Tumor-related Protein Coding | CAR-T cells | anti-CEA CAR-T cells | Hepatic arterial infusion or splenic vein | 1 | Active, not recruiting Estimated Completion Date: Dec, 2019 | |
| 28 | NCT01373047 | Metastatic Liver Tumors from Colorectal, Pancreas, Gastric, Breast, and Ovarian Cancers | CEA | Tumor-related Protein Coding | T cell | anti-CEA 2nd generation designer T cells | Hepatic arterial infusion or splenic vein | 1 | Completed No results reported to date | |
| 29 | NCT02432963 | Adult Solid Neoplasm | p53 | Tumor suppressor | Modified vaccinia virus | Vaccination | 1 | Active, not recruiting Estimated Completion Date: Feb, 2020 | ||
| 30 | NCT02715362 | HCC | GPC3 | Tumor-related Protein Coding | CAR-T cells | TAI-GPC3-CART cells | Hepatic arterial infusion | 1/2 | Recruiting No results available | |
| 31 | NCT00301106 | Metastatic Liver Tumors from Colorectal, Pancreas, Gastric, Breast, and Ovarian Cancers | Interleukin-12 | Genetic Immunotherapy | Adenoviral Vector | adenovirus-mediated human interleukin-12 | Intratumoral Injection | 1 | Terminated No results available | |
| 32 | NCT00072098 | Metastatic Liver Tumors from Colorectal, Pancreas, Gastric, Breast, and Ovarian Cancers | Interleukin-12 | Genetic Immunotherapy | Adenoviral Vector | adenoviral vector-delivered interleukin-12 | Intratumoral Injection | 1 | Terminated No results available | |
| 33 | NCT03198546 | HCC | GPC3 | Tumor-related Protein Coding | CAR-T cells | GPC3 targeting CAR-T cells | Systemic or local injections | 1 | Recruiting No results available Estimated Completion Date: Aug, 2022 | [87] |
| 34 | NCT00103142 | Metastatic Liver Tumors from Colorectal, Pancreas, Gastric, Breast, and Ovarian Cancers | Vaccinia-Carcinoembryonic antigen (CEA)-mucin 1 (MUC-1)- Triad of costimulatory molecules TRICOM vaccine (PANVAC-V) | Tumor-related Protein Coding | Autologous dendritic cells | Vaccination | 2 | Completed Results available | [95] |
HCC, hepatocellular carcinoma; CCC, cholangiocellular carcinoma; TACE, transarterial chemoembolization; TAE, transarterial embolization; HSVtk, thymidine kinase of herpes simplex virus; NY-ESO-1, New York esophageal squamous cell carcinoma 1; GPC-3, Glypican-3; LT, liver transplantation.