NCT04952272

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
124mo left

Started Mar 2021

Longer than P75 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Mar 2021Jun 2036

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2036

Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

8.3 years

First QC Date

June 27, 2021

Last Update Submit

June 22, 2024

Conditions

Lung CancerHepatocellular CarcinomaSolid Tumor

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 36 months

Study Arms (1)

Intratumor CpG-ODN Injection

EXPERIMENTAL

CpG-ODN will be Injected into the tumor.

Combination Product: CpG-ODN

Interventions

CpG-ODNCOMBINATION_PRODUCT

CAR-T cells secreting scFv against OX40

Also known as: Interventional therapy technique including microwave ablation or drug-eluting beads
Intratumor CpG-ODN Injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solid advanced malignant tumors
  • Age between18 and 80 years
  • Life expectancy is greater than three months

You may not qualify if:

  • Benign tumor
  • Life expectancy is less than three months
  • Serious medical comorbidity
  • Others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Hepatocellular

Interventions

CPG-oligonucleotide

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Zhenfeng Zhang, MD, PhD

    Second Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD, PhD

CONTACT

+862039195966zhangzhf@gzhmu.edu.cn

Bingjia He, MD

CONTACT

+862039195965464677938@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 7, 2021

Study Start

March 1, 2021

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2036

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)