NCT05113290

Effect and Safety of Recombinant Human Adenovirus Type 5 in Advanced HCC With Stable Disease After Sorafenib Treatment

Status unknown Phase 4 Last updated 27 January 2022

What this trial tests

Phase 4 trial testing Recombinant Human Adenovirus Type 5 injection in Hepatocellular Carcinoma in 66 participants. Status unknown.

Timeline

28 December 2021

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	First Affiliated Hospital Xi'an Jiaotong University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	28 December 2021
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	4 locations across China

Drugs / interventions tested

• Recombinant Human Adenovirus Type 5 injection — full drug profile →
• Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Who can join

Adults 18 to 70, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sorafenib, as a first-line treatment for patients with advanced HCC, can significantly prolong the overall survival rate of patients. However, about 53-71% of patients showed stable disease (SD) after sorafenib treatment, and further studies to explore optimal therapy for these patients are still needed.

Oncolytic viruses are a type of virus that can selectively replicate in tumor cells and then destroy tumor cells, of which recombinant human adenovirus type 5 (H101) is the first oncolytic virus drug which was approved in the world. Recent studies indicate that H101 shows anti-tumor effects on liver cancer and there may be a synergistic effect between recombinant human adenovirus type 5 and sorafenib in the inhabitation of hepatoma cells in vitro. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with sorafenib in the treatment of advanced hepatocellular carcinoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Therapies for Hepatocellular Carcinoma (HCC).
   Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798
2. Improving cancer immunotherapy by rationally combining oncolytic virus with modulators targeting key signaling pathways.
   Zhu Z, McGray AJR, Jiang W, Lu B, et al · · 2022 · cited 74× · PMID 36221123 · DOI 10.1186/s12943-022-01664-z
3. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
4. Recent advances in oncolytic virus therapy for hepatocellular carcinoma.
   Zhu L, Lei Y, Huang J, An Y, et al · · 2023 · cited 18× · PMID 37182136 · DOI 10.3389/fonc.2023.1172292
5. A Renaissance for Oncolytic Adenoviruses?
   Blanchette P, Teodoro JG. · · 2023 · cited 18× · PMID 36851572 · DOI 10.3390/v15020358
6. Oncolytic Adenoviruses Armed with Co-Stimulatory Molecules for Cancer Treatment.
   Gryciuk A, Rogalska M, Baran J, Kuryk L, et al · · 2023 · cited 13× · PMID 37046608 · DOI 10.3390/cancers15071947
7. Oncolytic virotherapy for hepatocellular carcinoma: A potent immunotherapeutic landscape.
   Xiao R, Jin H, Huang F, Huang B, et al · · 2024 · cited 5× · PMID 39072175 · DOI 10.4251/wjgo.v16.i7.2867
8. Viral warriors: Unlocking the immune system's potential with oncolytic viruses in cancer immunotherapy.
   Ghavimi R, Rahimian L, Mohammadi M, Dutta O, et al · · 2025 · cited 3× · PMID 41438130 · DOI 10.1016/j.omton.2025.201100