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

Primary Purpose

Lung Cancer, Hepatocellular Carcinoma, Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CpG-ODN
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Outcomes

Primary Outcome Measures

Assessing safety and treatment efficacy on intratumor injection of CpG-ODN and in situ tumor antigen release for advanced tumors
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.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2021
Last Updated
February 26, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborators
Guangdong Zhaotai InVivo Biomedicine Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04952272
Brief Title
Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Release for Advanced Solid Tumors
Official Title
Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Released by Interventional Approaches for Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborators
Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
Percutaneous microwave ablation or intratumor injection of drug-eluting beads to destroy cancer cells to release tumor-specific antigens Intratumor injection of type A/C CpG-ODN with or without infusion of CAR-T cells secreting scFv against OX40 Assessing side effects and therapeutic efficacy after the combined treatments

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Hepatocellular Carcinoma, Solid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Combination Product
Intervention Name(s)
CpG-ODN
Other Intervention Name(s)
Interventional therapy technique including microwave ablation or drug-eluting beads
Intervention Description
CAR-T cells secreting scFv against OX40
Primary Outcome Measure Information:
Title
Assessing safety and treatment efficacy on intratumor injection of CpG-ODN and in situ tumor antigen release for advanced tumors
Description
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.
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenfeng Zhang, MD, PhD
Phone
+862039195966
Email
zhangzhf@gzhmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Bingjia He, MD
Phone
+862039195965
Email
464677938@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenfeng Zhang, MD, PhD
Organizational Affiliation
Second Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenfeng Zhang, MD, PhD
Phone
+862039195966
Email
zhangzhf@gzhmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Bingjia He, MD
Phone
+862039195965
Email
464677938@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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