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Intra-tumor Injection of Drug-eluting Microspheres

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04770207
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Guangzhou Medical University

Study Description
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Brief Summary:
To study the safety and clinical effect of injection of drug-eluting microspheres into advanced solid tumors.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Solid Tumor, Adult Drug: Injection of drug-eluting microspheres into malignant tumors Phase 2

Detailed Description:
Assessing side effects and treatment efficacy after injection of drug-eluting microspheres into malignant tumors
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-tumor Injection of Drug-eluting Microspheres for Treatment of Advanced Solid Tumors
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tumor diameter
Comparison of tumor diameter one month after injection of drug-eluting microspheres
 Drug: Injection of drug-eluting microspheres into malignant tumors
Under the guidance of CT, puncture needle was used to inject drug-eluting microspheres into the tumor


Outcome Measures
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Primary Outcome Measures :
  1. Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors [ Time Frame: up to 36 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770207


Contacts
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Contact: Bingjia He, MD +862039195965 464677938@qq.com
Contact: Zhenfeng Zhang, MD, PhD +862039195966 zhangzhf@gzhmu.edu.cn

Locations
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China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510260
Contact: BINGJIA HE, MD    13560199303    464677938@qq.com   
Contact: Zhenfeng Zhang, MD, PhD    +862039195966    zhangzhf@gzhmu.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: Zhenfeng Zhang, MD, PhD Second Affiliated Hospital of Guangzhou Medical University
More Information
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Publications:

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Responsible Party: Second Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT04770207    
Other Study ID Numbers: DEB on malignant tumors
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Second Affiliated Hospital of Guangzhou Medical University:
Hepatocellular Carcinoma; Lung Cancer
Drug-eluting Beads
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases