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

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Enrolling; Phase 2

Conditions: Solid Tumor, Adult; Hepatocellular Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04770207

ZZITDEB-010

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

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

Experimental group

Description:

Intra-tumor injection of above drugs for patients with previous treatment with PDL1 antibody and relapsed.

Treatment:

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

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

Experimental group

Description:

Intra-tumor injection of above drugs for patients with previous treatment with PD1 antibody and relapsed.

Treatment:

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 group

Description:

Intra-tumor injection of above drugs for patients with previous heavily treated with PD1/PDL1/CTLA4 antibodies and relapsed.

Treatment:

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