Hepatocellular CarcinomaNCT06190665
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
A study testing DEB-TACE with visualable microspheres and DEB-TACE with PVA microspheres in people with Hepatocellular Carcinoma, run by Zhongda Hospital at 2 sites in China.
Trial summary
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- DEB-TACE with visualable microspheres and DEB-TACE with PVA microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesChina
- Study dates
- 19 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- 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
- CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B
- ECOG PS score of 0-2
- With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm)
- Agree to participate in this trial and voluntarily sign the informed consent form
Who cannot join
- Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
- With diffuse liver tumor or extrahepatic metastasis, expected survival <6 months With sepsis or multiple organ dysfunction
- Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine >2 mg/dL)
- Significant reductions in white blood cells or platelets (white blood cells <3.0×10^9/L, platelets <50×10^9/L, hemoglobin<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by >3 seconds above the upper limit of normal)
- With severe infection (>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply
- With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
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- Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
- Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs
- Pregnant or lactating women
- Patients who are participating in other trial(s)
- Unsuitable for participation in this trial deemed by the researchers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yin-Hua Zou
- Recruiting
Zhongda Hospital，Southeast University
Nanjing, Jiangsu, 210009
Hai-Dong Zhu
About this study
Official title: DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Read the detailed description
This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- DEB-TACE with visualable microspheres, DEB-TACE with PVA microspheres
- Keywords
- Hepatocellular carcinoma, TACE, Microspheres
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACE with visualable microspheresDevice
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
DEB-TACE with PVA microspheresDevice
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres
| Study group | Role | What they receive |
|---|---|---|
| Visualable microspheres | Experimental | DEB-TACE with visualable microspheres Receives: Device: DEB-TACE with visualable microspheres |
| PVA microspheres | Active comparator | DEB-TACE with polyvinyl alcohol microspheres Receives: Device: DEB-TACE with PVA microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR) for target lesions 1 month after the last TACE treatment
Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
Measured: 1 month after last TACE treatment
Secondary outcomes (6)
Visualization score of embolic area
Evaluation will be performed, based on CBCT images after the first TACE treatment, or CT plain images after the last TACE treatment as follow: 3 points: dense imaging (imaging area >75% of tumor area); 2 points: mixed imaging (imaging area 25%-75% of tumor area); 1 point: weak imaging (imaging area <25% of tumor area); 0 point: not visible (no imaging in the tumor area).
Measured: Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment
Embolization success rate of target lesions
Defined as the number of successful embolizations for the target lesions / the total number of participants ×100%.
Measured: Immediately after each TACE treatment
Equipment performance evaluation
Includes,the visualization performance of the microspheres on the fluoroscopy or cone-beam CT imaging; whether the microspheres can be easy pushed and pass through the catheter smoothly; whether the micro-catheter will be blocked during the process of pushing and releasing?
Measured: From the begin to immediately after each TACE treatment
Disease control rate (DCR) for target lesions
Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images.
Measured: 1 month after the first TACE treatment, and 3 months after the last TACE treatment
Objective response rate（ORR）
Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images.
Measured: 1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment
Number of TACE treatments for target lesions
Totel times of TACE treatments for all target lesions
Measured: 6 month since the last TACE treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start19 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- DEB-TACE with visualable microspheres or PVA microspheres
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190665
- Sponsor's protocol ID
- CHANCE 2305
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial
- ClinicalTrials.gov ID
- NCT06190665
- Acronym / sponsor ID
- CHANCE 2305
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, TACE, Microspheres
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Detailed description
This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- DEB-TACE with visualable microspheres or PVA microspheres
| Arm | Type | Receives |
|---|---|---|
| Visualable microspheres | Experimental | Device: DEB-TACE with visualable microspheresDEB-TACE with visualable microspheres |
| PVA microspheres | Active comparator | Device: DEB-TACE with PVA microspheresDEB-TACE with polyvinyl alcohol microspheres |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B
- ECOG PS score of 0-2
- With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm)
- Agree to participate in this trial and voluntarily sign the informed consent form
Key exclusion criteria (11 listed)
- Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
- With diffuse liver tumor or extrahepatic metastasis, expected survival <6 months With sepsis or multiple organ dysfunction
- Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine >2 mg/dL)
- Significant reductions in white blood cells or platelets (white blood cells <3.0×10^9/L, platelets <50×10^9/L, hemoglobin<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by >3 seconds above the upper limit of normal)
- With severe infection (>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply
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 |
|---|---|---|
| DEB-TACE with visualable microspheresDrug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres | Device | Visualable microspheres |
| DEB-TACE with PVA microspheresDrug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres | Device | PVA microspheres |
Primary outcome
Disease control rate (DCR) for target lesions 1 month after the last TACE treatment
Time frame: 1 month after last TACE treatment
Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
6 secondary outcomes
Visualization score of embolic area
Time frame: Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment
Embolization success rate of target lesions
Time frame: Immediately after each TACE treatment
Equipment performance evaluation
Time frame: From the begin to immediately after each TACE treatment
Disease control rate (DCR) for target lesions
Time frame: 1 month after the first TACE treatment, and 3 months after the last TACE treatment
Objective response rate（ORR）
Time frame: 1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment
Number of TACE treatments for target lesions
Time frame: 6 month since the last TACE treatment
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 12 Jan 2024.
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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.
Gao-Jun Teng principal investigator
Zhongda Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEB-TACE with visualable microspheres and DEB-TACE with PVA microspheres in people with Hepatocellular Carcinoma, run by Zhongda Hospital at 2 sites 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 4 inclusion and 11 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Hai-Dong Zhu (+86-25-83272121, zhuhaidong9509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) for target lesions 1 month after the last TACE treatment (time frame: 1 month after last TACE treatment). 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 12 Jan 2024.