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NCT Number: NCT04770207

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

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Solid Tumor, Adult Thoracic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingjia He, MD

CONTACT

[email protected]

+862039195965

Zhenfeng Zhang, MD, PhD

CONTACT

[email protected]

+862039195966

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2029
Study completion
2035
First posted
Feb 25, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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