drugset / Trial / NCT05113290

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

NCT05113290

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-12-28
Primary completion
2023-12-01
Completion
2023-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject H101 Other / unclassified 1e+12 unknown Other
Subject H101 Other / unclassified 1.5e+12 unknown Other
Subject Sorafenib Small molecule