Hepatocellular CarcinomaPhase 2NCT04770207
Intra-tumor Injection of Drug-eluting Microspheres With Multiple Drugs
A Phase 2 study testing Injection of drug-eluting microspheres with multiple drugs into solid tumors in people with Hepatocellular Carcinoma and Solid Tumor, Adult, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatocellular Carcinoma, Solid Tumor, Adult
- What is being tested?
- Injection of drug-eluting microspheres with multiple drugs into solid tumors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Nov 2035
- Phase
- Phase 2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid advanced malignant tumors
- Age between18 and 99 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
BINGJIA HE, MD, 13560199303, 464677938@qq.com
Zhenfeng Zhang, MD, PhD, +862039195966, zhangzhf@gzhmu.edu.cn
About this study
Official title: Intra-tumor Injection of Drug-eluting Microspheres Loading With Chemodrug Plus Checkpoint Inhibitors and/or IL2 for Treatment of Advanced Solid Tumors
To study the safety and clinical effect of injection of drug-eluting microspheres with multiple chemodrug and/or protein drugs into advanced solid tumors.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Solid Tumor, Adult
- Being tested
- Injection of drug-eluting microspheres with multiple drugs into solid tumors
- Keywords
- Hepatocellular Carcinoma; Lung Cancer; Solid Tumors, Drug-eluting Beads, IL2; Kytruda; Opdivo; Imfinza; Atezolizumab; Ipilimumab;, Treprizolizumab; Tirelizumab; Carellizumab; Sintilimab;, Sugemalimab；Adebrelimab；Envafolimab；Cadonilimab；, Bevacizumab; Ramucirumab
- Medical subject headings
- Carcinoma, Hepatocellular, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of drug-eluting microspheres with multiple drugs into solid tumorsDrug
Also called Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug
Under the guidance of CT, puncture fine needle was used to inject drug-eluting microspheres loading with multiple drugs into the tumor
| Study group | Role | What they receive |
|---|---|---|
| Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies | Experimental | Intra-tumor injection of above drugs for patients with previous treatment with PDL1 antibody and relapsed. Receives: Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumors |
| Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies | Experimental | Intra-tumor injection of above drugs for patients with previous treatment with PD1 antibody and relapsed. Receives: Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumors |
| Group 3: DC-Beads loading with Chemodrug/IL2/PD1/PDL1/CTLA4 antibodies | Experimental | Intra-tumor injection of above drugs for patients with previous heavily treated with PD1/PDL1/CTLA4 antibodies and relapsed. Receives: Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors
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.
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 posted25 Feb 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Drug-eluting beads loaded with various drugs including IL2, kytruda, imfinzi, yevoy, bevacizumag, or/and ramucirumab, doxorubicin/idarubicin are injected into solid tumors under CT guidance according to appropriate treatment strategy, once per 3-6 weeks, and the safety and efficacy will be evaluated by guidelines.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenfeng Zhang, MD, PhD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770207
- Sponsor's protocol ID
- ZZITDEB-010
- Status last verified
- Aug 2024
- First submitted
- 2 Dec 2020
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borde T, Laage Gaupp F, Geschwind JF, Savic LJ, Miszczuk M, Rexha I, Adam L, Walsh JJ, Huber S, Duncan JS, Peters DC, Sinusas A, Schlachter T, Gebauer B, Hyder F, Coman D, van Breugel JMM, Chapiro J. Idarubicin-Loaded ONCOZENE Drug-Eluting Bead Chemoembolization in a Rabbit Liver Tumor Model: Investigating Safety, Therapeutic Efficacy, and Effects on Tumor Microenvironment. J Vasc Interv Radiol. 2020 Oct;31(10):1706-1716.e1. doi: 10.1016/j.jvir.2020.04.010. Epub 2020 Jul 17.
PubMed 32684417Binder S, Lewis AL, Lohr JM, Keese M. Extravascular use of drug-eluting beads: a promising approach in compartment-based tumor therapy. World J Gastroenterol. 2013 Nov 21;19(43):7586-93. doi: 10.3748/wjg.v19.i43.7586.
PubMed 24282349Baur J, Ritter CO, Germer CT, Klein I, Kickuth R, Steger U. Transarterial chemoembolization with drug-eluting beads versus conventional transarterial chemoembolization in locally advanced hepatocellular carcinoma. Hepat Med. 2016 Jun 20;8:69-74. doi: 10.2147/HMER.S105395. eCollection 2016.
PubMed 27382341Malagari K. Drug-eluting particles in the treatment of HCC: chemoembolization with doxorubicin-loaded DC Bead. Expert Rev Anticancer Ther. 2008 Oct;8(10):1643-50. doi: 10.1586/14737140.8.10.1643.
PubMed 18925855Rossi SM, Murray T, McDonough L, Kelly H. Loco-regional drug delivery in oncology: current clinical applications and future translational opportunities. Expert Opin Drug Deliv. 2021 May;18(5):607-623. doi: 10.1080/17425247.2021.1856074. Epub 2020 Dec 16.
PubMed 33253052Fuchs K, Duran R, Denys A, Bize PE, Borchard G, Jordan O. Drug-eluting embolic microspheres for local drug delivery - State of the art. J Control Release. 2017 Sep 28;262:127-138. doi: 10.1016/j.jconrel.2017.07.016. Epub 2017 Jul 11.
PubMed 28710006
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-tumor Injection of Drug-eluting Microspheres Loading With Chemodrug Plus Checkpoint Inhibitors and/or IL2 for Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04770207
- Acronym / sponsor ID
- ZZITDEB-010
- Conditions
- Hepatocellular Carcinoma, Solid Tumor, Adult
- Keywords
- Hepatocellular Carcinoma; Lung Cancer; Solid Tumors, Drug-eluting Beads, IL2; Kytruda; Opdivo; Imfinza; Atezolizumab; Ipilimumab;, Treprizolizumab; Tirelizumab; Carellizumab; Sintilimab;, Sugemalimab；Adebrelimab；Envafolimab；Cadonilimab；, Bevacizumab; Ramucirumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2035 (estimated)
- First posted
- 25 Feb 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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Drug-eluting beads loaded with various drugs including IL2, kytruda, imfinzi, yevoy, bevacizumag, or/and ramucirumab, doxorubicin/idarubicin are injected into solid tumors under CT guidance according to appropriate treatment strategy, once per 3-6 weeks, and the safety and efficacy will be evaluated by guidelines.
| Arm | Type | Receives |
|---|---|---|
| Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies | Experimental | Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumorsIntra-tumor injection of above drugs for patients with previous treatment with PDL1 antibody and relapsed. |
| Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies | Experimental | Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumorsIntra-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 | Experimental | Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumorsIntra-tumor injection of above drugs for patients with previous heavily treated with PD1/PDL1/CTLA4 antibodies and relapsed. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Solid advanced malignant tumors
- Age between18 and 99 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 |
|---|---|---|
| Injection of drug-eluting microspheres with multiple drugs into solid tumorsAlso: Checkpoint inhibitor (CPI) such as Keytruda plus chemodrugUnder the guidance of CT, puncture fine needle was used to inject drug-eluting microspheres loading with multiple drugs into the tumor | Drug | Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies, Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies, Group 3: DC-Beads loading with Chemodrug/IL2/PD1/PDL1/CTLA4 antibodies |
Primary outcome
Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors
Time frame: 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.
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 21 Aug 2024.
- Background: PubMed 32684417Borde T, Laage Gaupp F, Geschwind JF, Savic LJ, Miszczuk M, Rexha I, Adam L, Walsh JJ, Huber S, Duncan JS, Peters DC, Sinusas A, Schlachter T, Gebauer B, Hyder F, Coman D, van Breugel JMM, Chapiro J. Idarubicin-Loaded ONCOZENE Drug-Eluting Bead Chemoembolization in a Rabbit Liver Tumor Model: Investigating Safety, Therapeutic Efficacy, and Effects on Tumor Microenvironment. J Vasc Interv Radiol. 2020 Oct;31(10):1706-1716.e1. doi: 10.1016/j.jvir.2020.04.010. Epub 2020 Jul 17.
- Background: PubMed 24282349Binder S, Lewis AL, Lohr JM, Keese M. Extravascular use of drug-eluting beads: a promising approach in compartment-based tumor therapy. World J Gastroenterol. 2013 Nov 21;19(43):7586-93. doi: 10.3748/wjg.v19.i43.7586.
- Background: PubMed 27382341Baur J, Ritter CO, Germer CT, Klein I, Kickuth R, Steger U. Transarterial chemoembolization with drug-eluting beads versus conventional transarterial chemoembolization in locally advanced hepatocellular carcinoma. Hepat Med. 2016 Jun 20;8:69-74. doi: 10.2147/HMER.S105395. eCollection 2016.
- Background: PubMed 18925855Malagari K. Drug-eluting particles in the treatment of HCC: chemoembolization with doxorubicin-loaded DC Bead. Expert Rev Anticancer Ther. 2008 Oct;8(10):1643-50. doi: 10.1586/14737140.8.10.1643.
- Background: PubMed 33253052Rossi SM, Murray T, McDonough L, Kelly H. Loco-regional drug delivery in oncology: current clinical applications and future translational opportunities. Expert Opin Drug Deliv. 2021 May;18(5):607-623. doi: 10.1080/17425247.2021.1856074. Epub 2020 Dec 16.
- Background: PubMed 28710006Fuchs K, Duran R, Denys A, Bize PE, Borchard G, Jordan O. Drug-eluting embolic microspheres for local drug delivery - State of the art. J Control Release. 2017 Sep 28;262:127-138. doi: 10.1016/j.jconrel.2017.07.016. Epub 2017 Jul 11.
- 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 2 study testing Injection of drug-eluting microspheres with multiple drugs into solid tumors in people with Hepatocellular Carcinoma and Solid Tumor, Adult, 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 21 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Bingjia He, MD (+862039195965, 464677938@qq.com), 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 intra-tumor injection of DEB 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?
On the ClinicalTrials.gov record for NCT04770207, which also lists 6 linked publications.
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 21 Aug 2024.