Lung CancerPhase 1NCT04952272
Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Release for Advanced Solid Tumors
A Phase 1 study testing CpG-ODN in people with Lung Cancer and Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Hepatocellular Carcinoma, Solid Tumor
- What is being tested?
- CpG-ODN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Jun 2036
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid advanced malignant tumors
- Age between18 and 80 years
- Life expectancy is greater than three months
Who cannot join
- Benign tumor
- Life expectancy is less than three months
- Serious medical comorbidity
- Others
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Zhenfeng Zhang, MD, PhD, +862039195966, zhangzhf@gzhmu.edu.cn
Bingjia He, MD, +862039195965, 464677938@qq.com
About this study
Official title: Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Released by Interventional Approaches for Advanced Solid Tumors
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.
Read the 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
- Conditions
- Lung Cancer, Hepatocellular Carcinoma, Solid Tumor
- Being tested
- CpG-ODN
- Medical subject headings
- Lung Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CpG-ODNCombination product
Also called Interventional therapy technique including microwave ablation or drug-eluting beads
CAR-T cells secreting scFv against OX40
| Study group | Role | What they receive |
|---|---|---|
| Intratumor CpG-ODN Injection | Experimental | CpG-ODN will be Injected into the tumor. Receives: Combination Product: CpG-ODN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Mar 2021
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Zhaotai InVivo Biomedicine Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhenfeng Zhang, MD, PhD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952272
- Sponsor's protocol ID
- ZZITCpG-013
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2021
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Released by Interventional Approaches for Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04952272
- Acronym / sponsor ID
- ZZITCpG-013
- Conditions
- Lung Cancer, Hepatocellular Carcinoma, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Guangdong Zhaotai InVivo Biomedicine Co. Ltd.
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2036 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intratumor CpG-ODN Injection | Experimental | Combination Product: CpG-ODNCpG-ODN will be Injected into the tumor. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Solid advanced malignant tumors
- Age between18 and 80 years
- Life expectancy is greater than three months
Key exclusion criteria (4 listed)
- Benign tumor
- Life expectancy is less than three months
- Serious medical comorbidity
- Others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CpG-ODNAlso: Interventional therapy technique including microwave ablation or drug-eluting beadsCAR-T cells secreting scFv against OX40 | Combination product | Intratumor CpG-ODN Injection |
Primary outcome
Assessing safety and treatment efficacy on intratumor injection of CpG-ODN and in situ tumor antigen release for advanced tumors
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenfeng Zhang, MD, PhD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CpG-ODN in people with Lung Cancer and Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenfeng Zhang, MD, PhD (+862039195966, zhangzhf@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing safety and treatment efficacy on intratumor injection of CpG-ODN and in situ tumor antigen release for advanced tumors (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.