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

NCT ID: NCT04770207

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2035-11-01

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma Solid Tumor, Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Drug-eluting beads loaded with various drugs including IL2, kytruda, imfinzi, yevoy, bevacizumag, or/and ramucirumab, doxorubicin/idarubicin are injected into solid tumors under CT guidance according to appropriate treatment strategy, once per 3-6 weeks, and the safety and efficacy will be evaluated by guidelines.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Injection of drug-eluting microspheres with multiple drugs into solid tumors

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Injection of drug-eluting microspheres with multiple drugs into solid tumors

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Injection of drug-eluting microspheres with multiple drugs into solid tumors

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhenfeng Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

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The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bingjia He, MD

Role: CONTACT

+862039195965

Zhenfeng Zhang, MD, PhD

Role: CONTACT

+862039195966

Facility Contacts

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BINGJIA HE, MD

Role: primary

13560199303

Zhenfeng Zhang, MD, PhD

Role: backup

+862039195966

References

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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.

Reference Type BACKGROUND
PMID: 32684417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24282349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27382341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18925855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33253052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28710006 (View on PubMed)

Other Identifiers

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ZZITDEB-010

Identifier Type: -

Identifier Source: org_study_id

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