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

NCT04770207 | Recruiting Phase 2

• 1 other identifier: ZZITDEB-010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma; Solid Tumor, Adult

Keywords

Hepatocellular Carcinoma; Lung Cancer; Solid Tumors; Drug-eluting Beads; IL2; Kytruda; Opdivo; Imfinza; Atezolizumab; Ipilimumab;; Treprizolizumab; Tirelizumab; Carellizumab; Sintilimab;; Sugemalimab；Adebrelimab；Envafolimab；Cadonilimab；; Bevacizumab; Ramucirumab

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 36 months

Study Arms (3)

Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies

EXPERIMENTAL

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

Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies

EXPERIMENTAL

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

Group 3: DC-Beads loading with Chemodrug/IL2/PD1/PDL1/CTLA4 antibodies

EXPERIMENTAL

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

Interventions

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

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

Also known as: Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug

Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies; Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies; Group 3: DC-Beads loading with Chemodrug/IL2/PD1/PDL1/CTLA4 antibodies

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 32684417 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Lung Neoplasms

Interventions

cyclopropapyrroloindole; pembrolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhenfeng Zhang, MD, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingjia He, MD

CONTACT

+862039195965; 464677938@qq.com

Zhenfeng Zhang, MD, PhD

CONTACT

+862039195966; zhangzhf@gzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: February 25, 2021
• Study Start: November 1, 2020
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2035
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)