Clinical trial NCT04770207: Intra-tumor Injection of Drug-eluting Microspheres With Multiple Drugs
Official title: Intra-tumor Injection of Drug-eluting Microspheres Loading With Chemodrug Plus Checkpoint Inhibitors and/or IL2 for Treatment of Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Zhenfeng Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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