drugset / Trial / NCT04770207
Intra-tumor Injection of Drug-eluting Microspheres With Multiple Drugs
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To study the safety and clinical effect of injection of drug-eluting microspheres with multiple chemodrug and/or protein drugs into advanced solid tumors.
Timeline
- Start
- 2020-11-01
- Primary completion
- 2029-11-01
- Completion
- 2035-11-01
Publications
- Background Borde T, Laage Gaupp F, Geschwind JF, Savic LJ, Miszczuk M, Rexha I, Adam L, Walsh JJ, Huber S, Duncan JS, Peters DC, Sinusas A, Schlachter T, Gebauer B, Hyder F, Coman D, van Breugel JMM, Chapiro J. Idarubicin-Loaded ONCOZENE Drug-Eluting Bead Chemoembolization in a Rabbit Liver Tumor Model: Investigating Safety, Therapeutic Efficacy, and Effects on Tumor Microenvironment. J Vasc Interv Radiol. 2020 Oct;31(10):1706-1716.e1. doi: 10.1016/j.jvir.2020.04.010. Epub 2020 Jul 17.
- Background Binder S, Lewis AL, Lohr JM, Keese M. Extravascular use of drug-eluting beads: a promising approach in compartment-based tumor therapy. World J Gastroenterol. 2013 Nov 21;19(43):7586-93. doi: 10.3748/wjg.v19.i43.7586.
- Background Baur J, Ritter CO, Germer CT, Klein I, Kickuth R, Steger U. Transarterial chemoembolization with drug-eluting beads versus conventional transarterial chemoembolization in locally advanced hepatocellular carcinoma. Hepat Med. 2016 Jun 20;8:69-74. doi: 10.2147/HMER.S105395. eCollection 2016.
- Background Malagari K. Drug-eluting particles in the treatment of HCC: chemoembolization with doxorubicin-loaded DC Bead. Expert Rev Anticancer Ther. 2008 Oct;8(10):1643-50. doi: 10.1586/14737140.8.10.1643.
- Background Rossi SM, Murray T, McDonough L, Kelly H. Loco-regional drug delivery in oncology: current clinical applications and future translational opportunities. Expert Opin Drug Deliv. 2021 May;18(5):607-623. doi: 10.1080/17425247.2021.1856074. Epub 2020 Dec 16.
- Background Fuchs K, Duran R, Denys A, Bize PE, Borchard G, Jordan O. Drug-eluting embolic microspheres for local drug delivery - State of the art. J Control Release. 2017 Sep 28;262:127-138. doi: 10.1016/j.jconrel.2017.07.016. Epub 2017 Jul 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adebrelimab | Monoclonal antibody | — | — |
| Subject | Atezolizumab | Monoclonal antibody | — | — |
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Cadonilimab | Monoclonal antibody | — | — |
| Subject | Carellizumab | Unknown | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Envafolimab | Monoclonal antibody | — | — |
| Subject | IL-2 | Protein / enzyme biologic | — | — |
| Subject | Idarubicin | Small molecule | — | — |
| Subject | Imfinza | Unknown | — | — |
| Subject | Ipilimumab | Monoclonal antibody | — | — |
| Subject | Kytruda | Unknown | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Ramucirumab | Monoclonal antibody | — | — |
| Subject | Sintilimab | Monoclonal antibody | — | — |
| Subject | Sugemalimab | Monoclonal antibody | — | — |
| Subject | Tirelizumab | Monoclonal antibody | — | — |
| Subject | Treprizolumab | Unknown | — | — |