Unresectable Hepatocellular CarcinomaNCT06593964
TACE With Thermosensitive Nanogel Versus Embosphere for HCC
A study testing Thermosensitive Nanogel Embolic Agent in people with Unresectable Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Thermosensitive Nanogel Embolic Agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;
- Liver function status: Child-Pugh A or B
- Eastern Cooperative Oncology Group score: 0-2 points;
- With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;
- Willing to participate in this trial and sign the informed consent.
Who cannot join
- The target lesion has been embolized before or require combined with other treatment(s);
- Diffuse or with extrahepatic metastasis;
- Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);
- Severe renal dysfunctions (creatinine clearance rate <30 ml/min);
- Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);
- Main portal vein was completely occluded and no collateral blood supply was established;
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- With uncorrectable arteriovenous fistula or portal vein fistula;
- Severe cachexia or hepatic encephalopathy;
- With active infection;
- Significant reductions in white blood cells or platelets (white blood cells<3.0x109/L, platelets<50x109/L) that cannot be corrected;
- Pregnant or lactating women;
- Difficulty in selective catheterization;
- With the severe risk of non-target embolization;
- Severely allergic to contrast agents or the embolic materials;
- Participating in ongoing trial;
- Unsuitable judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
Read the detailed description
This is a prospective, multicenter, randomized controlled, non-inferiority design trial. Participants who meet the criteria will be randomly assigned into the experimental group or the control group，with a ratio of 1:1. In the experimental group the Thermosensitive Nanogel Embolic Agent will be used in the TACE procedure, while in the control group the Embosphere microspheres will be used. The primary endpoint is disease control rate of the target lesions at 1 month after the last TACE treatment.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Thermosensitive Nanogel Embolic Agent
- Keywords
- Hepatocellular carcinoma, Transarterial Chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermosensitive Nanogel Embolic AgentDevice
Thermosensitive Nanogel Embolic Agent
| Study group | Role | What they receive |
|---|---|---|
| TACE with Thermosensitive Nanogel Embolic Agent | Experimental | Equipment:
Thermosensitive Nanogel Embolic Agent Receives: Device: Thermosensitive Nanogel Embolic Agent |
| TACE with Embosphere Microspheres | Active comparator | Equipment:
Embosphere Microspheres Receives: Device: Thermosensitive Nanogel Embolic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR)
Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST).
Measured: One month after the last TACE
Secondary outcomes (5)
Success rate of target lesion embolization
Success rate of target lesion embolization, evaluated by the investigator and independent image review committee respectively.
Measured: One month after the last TACE
Objective response rate (ORR)
Objective response rate of target lesions, evaluated by the investigator and independent image review committee respectively (mRECIST).
Measured: One month after the last TACE treatment
Disease control rate (DCR)
Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST).
Measured: Three and six months after the first TACE
Equipment performance evaluation
(Intraoperative imaging ability, microcatheter delivery capacity) evaluated by the investigator.
Measured: One month after the first TACE
Adverse events
Rate of adverse events, evaluated by the investigator (CTACE 5.0)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable 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
- 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, M.D., Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593964
- Sponsor's protocol ID
- CHANCE-2416
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06593964
- Acronym / sponsor ID
- CHANCE-2416
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Transarterial Chemoembolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Sep 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.
To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
Detailed description
This is a prospective, multicenter, randomized controlled, non-inferiority design trial. Participants who meet the criteria will be randomly assigned into the experimental group or the control group，with a ratio of 1:1. In the experimental group the Thermosensitive Nanogel Embolic Agent will be used in the TACE procedure, while in the control group the Embosphere microspheres will be used. The primary endpoint is disease control rate of the target lesions at 1 month after the last TACE treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE with Thermosensitive Nanogel Embolic Agent | Experimental | Device: Thermosensitive Nanogel Embolic AgentEquipment: Thermosensitive Nanogel Embolic Agent |
| TACE with Embosphere Microspheres | Active comparator | Device: Thermosensitive Nanogel Embolic AgentEquipment: Embosphere Microspheres |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;
- Liver function status: Child-Pugh A or B
- Eastern Cooperative Oncology Group score: 0-2 points;
- With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;
- Willing to participate in this trial and sign the informed consent.
Key exclusion criteria (16 listed)
- The target lesion has been embolized before or require combined with other treatment(s);
- Diffuse or with extrahepatic metastasis;
- Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);
- Severe renal dysfunctions (creatinine clearance rate <30 ml/min);
- Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);
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 |
|---|---|---|
| Thermosensitive Nanogel Embolic AgentThermosensitive Nanogel Embolic Agent | Device | TACE with Embosphere Microspheres, TACE with Thermosensitive Nanogel Embolic Agent |
Primary outcome
Disease control rate (DCR)
Time frame: One month after the last TACE
Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST).
5 secondary outcomes
Success rate of target lesion embolization
Time frame: One month after the last TACE
Objective response rate (ORR)
Time frame: One month after the last TACE treatment
Disease control rate (DCR)
Time frame: Three and six months after the first TACE
Equipment performance evaluation
Time frame: One month after the first TACE
Adverse events
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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. This study is not recruiting at the moment.
Gao-Jun Teng, M.D. principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermosensitive Nanogel Embolic Agent in people with Unresectable Hepatocellular Carcinoma, run by Zhongda Hospital 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 19 Sep 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhang, M.D. (+86 13770106862, llei589@126.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) (time frame: One month after the last TACE). 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 19 Sep 2024.