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

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma; Solid Tumor, Adult
• Interventions: Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumors

• Registration Number: NCT04770207
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2029-11-01
• Study Completion: 2035-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies	Injection of drug-eluting microspheres with multiple drugs into solid tumors	Intra-tumor injection of above drugs for patients with previous treatment with PD1 antibody and relapsed.
Group 3: DC-Beads loading with Chemodrug/IL2/PD1/PDL1/CTLA4 antibodies	Injection of drug-eluting microspheres with multiple drugs into solid tumors	Intra-tumor injection of above drugs for patients with previous heavily treated with PD1/PDL1/CTLA4 antibodies and relapsed.
Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies	Injection of drug-eluting microspheres with multiple drugs into solid tumors	Intra-tumor injection of above drugs for patients with previous treatment with PDL1 antibody and relapsed.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China