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

November 11, 2023 updated by: Second Affiliated Hospital of Guangzhou Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies
Intra-tumor injection of above drugs for patients with previous treatment with PDL1 antibody and relapsed.
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
Other Names:
  • Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug
Experimental: Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies
Intra-tumor injection of above drugs for patients with previous treatment with PD1 antibody and relapsed.
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
Other Names:
  • Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug
Experimental: Group 3: DC-Beads loading with Chemodrug/IL2/PD1/PDL1/CTLA4 antibodies
Intra-tumor injection of above drugs for patients with previous heavily treated with PD1/PDL1/CTLA4 antibodies and relapsed.
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
Other Names:
  • Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Zhenfeng Zhang, MD, PhD, Second Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZZITDEB-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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