search
Back to results

Intra-tumor Injection of Drug-eluting Microspheres

Primary Purpose

Hepatocellular Carcinoma, Solid Tumor, Adult

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Injection of drug-eluting microspheres into malignant tumors
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma; Lung Cancer, Drug-eluting Beads, IL2; kytruda; imfinza; yevoy, bevacizumab; ramucirumab

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tumor diameter

Arm Description

Comparison of tumor diameter 1-2 month before and after injection of drug-eluting microspheres.

Outcomes

Primary Outcome Measures

Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors
Assessing incidence of side effects and primary clinical response of the intra-tumor injection of DEB in advanced solid cancers, including CR, PR, SD, and PD.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2020
Last Updated
February 28, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04770207
Brief Title
Intra-tumor Injection of Drug-eluting Microspheres
Official Title
Intra-tumor Injection of Drug-eluting Microspheres for Treatment of Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the safety and clinical effect of injection of drug-eluting microspheres 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Solid Tumor, Adult
Keywords
Hepatocellular Carcinoma; Lung Cancer, Drug-eluting Beads, IL2; kytruda; imfinza; yevoy, bevacizumab; ramucirumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Drug-eluting beads loaded with various drugs including IL2, kytruda, imfinzi, yevoy, bevacizumag, or/and ramucirumab, doxorubicin are injected into solid tumors under CT guidance according to appropriate treatment strategy, once per 3 weeks, and the safety and efficacy will be evaluated by guidelines.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumor diameter
Arm Type
Experimental
Arm Description
Comparison of tumor diameter 1-2 month before and after injection of drug-eluting microspheres.
Intervention Type
Drug
Intervention Name(s)
Injection of drug-eluting microspheres into malignant tumors
Intervention Description
Under the guidance of CT, puncture fine needle was used to inject drug-eluting microspheres into the tumor
Primary Outcome Measure Information:
Title
Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors
Description
Assessing incidence of side effects and primary clinical response of the intra-tumor injection of DEB in advanced solid cancers, including CR, PR, SD, and PD.
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bingjia He, MD
Phone
+862039195965
Email
464677938@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenfeng Zhang, MD, PhD
Phone
+862039195966
Email
zhangzhf@gzhmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenfeng Zhang, MD, PhD
Organizational Affiliation
Second Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BINGJIA HE, MD
Phone
13560199303
Email
464677938@qq.com
First Name & Middle Initial & Last Name & Degree
Zhenfeng Zhang, MD, PhD
Phone
+862039195966
Email
zhangzhf@gzhmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32684417
Citation
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.
Results Reference
background
PubMed Identifier
24282349
Citation
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.
Results Reference
background
PubMed Identifier
27382341
Citation
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.
Results Reference
background
PubMed Identifier
18925855
Citation
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.
Results Reference
background
PubMed Identifier
33253052
Citation
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.
Results Reference
background
PubMed Identifier
28710006
Citation
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.
Results Reference
background

Learn more about this trial

Intra-tumor Injection of Drug-eluting Microspheres

We'll reach out to this number within 24 hrs