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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04770207

Enrollment

100

Registered

2021-02-25

Start date

2020-11-01

Completion date

2035-11-01

Last updated

2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

DRUGInjection 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors	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.

Countries

China

Contacts

Primary ContactBingjia He, MD

464677938@qq.com+862039195965

Backup ContactZhenfeng Zhang, MD, PhD

zhangzhf@gzhmu.edu.cn+862039195966

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026