Table 1.
Clinical trials using oncolytic adenovirus in HCC treatment.
| ClinicalTrials.gov Identities | Status | Study title | Conditions | Interventions | Locations | Trial phase | Number of patients | Purpose | Genetic modifications | |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01869088 | Unknown† | TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma | Hepatocellular Carcinoma | Drug: Recombinant Human Adenovirus Type 5 Injection Procedure: Transartery Chemoembolization | Cancer Center Sun Yat-sen University Guangzhou, Guangdong, China | Phase 3 | 266 | Determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery or local ablative therapy. | Ad5 E1B deleted |
| 2 | NCT03790059 | Recruiting | Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma. | Hepatocellular Carcinoma | Drug: H101 Procedure: RFA | Institute of hepatobiliary surgery, Southwest Hospital Chongqing, Chongqing, China Institute of hepatobiliary surgery, Southwest Hospital Chongqing, China | Not Applicable | 160 | Retrospectively compare the short-term and long-term efficacy of RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer (single lesion, diameter ≤ 3 cm). | H101 |
| 3 | NCT03780049 | Recruiting | HAIC Plus H101 vs. HAIC Alone for Unresectable HCC at BCLC A-B | Hepatocellular Carcinoma | Procedure: HAIC of FOLFOX Drug: H101 Drug: Placebos | Cancer Center Sun Yat-sen University Guangzhou, Guangdong, China | Phase 3 | 304 | Evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at Barcelona clinic liver cancer A-B stage. | H101 |
| 4 | NCT00844623 | Completed | TK-based Suicide Gene Therapy for Hepatocellular Carcinoma | Carcinoma, Hepatocellular | Genetic: TK99UN | Clinica Universitaria de Navarra Pamplona, Spain | Phase 1 | 10 | Determine whether activation of a prodrug after intratumoral gene transfer is safe in humans, and to determine dose levels for further clinical development. | Ad.TK encoding herpes simplex virus thymidine kinase |
| 5 | NCT02202564 | Completed | Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma | Liver Cancer Hepatocellular Carcinoma | Procedure: LT Drug: ADV-TK Drug: ganciclovir | Huazhong University of Science and Technology, Beijing Youan Hospital, China | Phase 2 | 81 | Determine whether Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced hepatocellular carcinoma (tumors >5 cm in diameter,). | Adenovirus-thymidine kinase |
| 6 | NCT02561546 | Unknown | p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma | HCC Diabetes | Drug: p53 gene therapy Drug: Trans-catheter embolization | First affiliated hospital in Dalian University Dalian, Liaoning, China | Phase 2 | 40 | Investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC). | rAd-p53 |
| 7 | NCT00300521 | Completed | Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma Liver Transplantation | Genetic: ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy | Beijing Chao Yang Hospital Beijing, Beijing, China | Phase 2 | 40 | Determine whether ADV-TK gene therapy improving outcome of Liver Transplantation in patients with intermediate or advanced HCC. | ADV-TK (encoding adenovirus-thymidine kinase enzyme) |
| 8 | NCT03313596 | Recruiting | Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC | Hepatocellular Carcinoma | Drug: ADV-Tk Procedure: LT | Beijing Youan Hospital Beijing, Beijing, China 301 Military Hospital Beijing, China General Hospital of Chinese People's Armed Police Beijing, China (and 8 more…) | Phase 3 | 180 | Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy vs. LT only in advanced primary hepatocellular carcinoma. | ADV-TK (encoding adenovirus-thymidine kinase enzyme) |
| 9 | NCT03563170 | Recruiting | QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine | Hepatocellular Carcinoma Non-resectable Hepatocellular Carcinoma Recurrent | Biological: ETBX-011 Biological: GI-4000 Biological: haNK for infusion (and 15 more…) | Chan Soon-Shiong Institute for Medicine El Segundo, California, United States | Phase 1, Phase 2 | 382 | Evaluate the safety and efficacy of metronomic combination therapy in subjects with advanced, unresectable, and untransplantable HCC. | |
| 10 | NCT02509169 | Unknown† | Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma | Advanced Hepatocellular Carcinoma (HCC) | Drug: TAE plus P53 gene Other: TAE | First affiliated hospital in Dalian University Dalian, Liaoning, China | Phase 1 | 60 | Investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC). | rAd-p53 |
| 11 | NCT02418988 | Unknown† | Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Drug: TACE plus rAd-p53 artery injection Drug: TACE | Xijing Hospital of the Fourth Military Medical University Xi An, Shanxi, China | Phase 1; | 120 | Investigate the efficacy and safety using TACE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC. | rAd-p5 |
†
Study has passed its completion date and status has not been verified in more than two years. Study was previously marked as Active, not recruiting.