Intratumor CpG-ODN Boosters Immune Killing Against in Situ Tumor Antigen Release for Advanced Solid Tumors

• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04952272
• Collaborator: Guangdong Zhaotai InVivo Biomedicine Co. Ltd. (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 184
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To study the safety and clinical effects of intratumor injecting CpG-ODN and in situ release of tumor antigen by interventional ablation or drug-eluting beads to treat advanced solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Hepatocellular Carcinoma; Solid Tumor	Combination Product: CpG-ODN	Phase 1

Detailed Description

1. Percutaneous microwave ablation or intratumor injection of drug-eluting beads to destroy cancer cells to release tumor-specific antigens

2. Intratumor injection of type A/C CpG-ODN with or without infusion of CAR-T cells secreting scFv against OX40

3. Assessing side effects and therapeutic efficacy after the combined treatments

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intratumor CpG-ODN Boosters Immune Killing Against in Situ Tumor Antigen Released by Interventional Approaches for Advanced Solid Tumors
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2036

Outcome Measures

Primary Outcome Measures

1. Assessing safety and treatment efficacy on intratumor injection of CpG-ODN and in situ tumor antigen release for advanced tumors [up to 36 months]

   Assessing incidence of side effects and primary clinical response of the intratumor injection of CpG-ODN and therpeutical in situ tumor antigen release for advanced tumors, including CR, PR, SD, and PD.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Solid advanced malignant tumors

• Age between18 and 80 years

• Life expectancy is greater than three months

Exclusion Criteria:

• Benign tumor

• Life expectancy is less than three months

• Serious medical comorbidity

• Others

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510260

Sponsors and Collaborators

• Second Affiliated Hospital of Guangzhou Medical University
• Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

Investigators

• Principal Investigator: Zhenfeng Zhang, MD, PhD, Second Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital of Guangzhou Medical University
• ClinicalTrials.gov Identifier: NCT04952272
• Other Study ID Numbers: CpG-ODN on tumors
• First Posted: Jul 7, 2021
• Last Update Posted: Jul 7, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Hepatocellular; CPG-oligonucleotide

Study Results

No Results Posted as of Jul 7, 2021