Menu
Recruiting NCT04770207

Intra-tumor Injection of Drug-eluting Microspheres With Multiple Drugs

Phase II Interventional Hepatocellular Carcinoma Solid Tumor, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Injection of drug-eluting microspheres with multiple drugs into solid tumors.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Solid Tumor, Adult. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intra-tumor Injection of Drug-eluting Microspheres Loading With Chemodrug Plus Checkpoint Inhibitors and/or IL2 for Treatment of Advanced Solid Tumors

Overview

To study the safety and clinical effect of injection of drug-eluting microspheres with multiple chemodrug and/or protein drugs into advanced solid tumors.

Detailed description

Drug-eluting microspheres such as DC-beads will be loaded with IL2, PD1/PDL1/CTLA4 antibody, or /and VEGF/VEGFR antibody with or without doxorubicin/idarubicin for various time and injected into tumors under CT guidance. Side effects and treatment efficacy after injection of drug-eluting microspheres into malignant tumors will be assessed according to RICEST1.1 standard.

Interventions

  • Drug Injection of drug-eluting microspheres with multiple drugs into solid tumors
    Under the guidance of CT, puncture fine needle was used to inject drug-eluting microspheres loading with multiple drugs into the tumor

Primary outcome measures

  • Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors [Time frame: up to 36 months]

Eligibility criteria

Inclusion criteria

  • Solid advanced malignant tumors
  • Age between18 and 99 years
  • Life expectancy is greater than three months

Exclusion criteria

  • Benign tumor
  • Life expectancy is less than three months
  • Serious medical comorbidity
  • Others

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou

Publications

  • 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. 2 PMID 32684417
  • 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. PMID 24282349
  • 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. PMID 27382341
  • 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. PMID 18925855
  • 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. PMID 33253052
  • 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. PMID 28710006

Identifiers

NCT: NCT04770207 · ZZITDEB-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗