Liver CancerPhase 4NCT06353126
DEB-TACE Prior to Liver Transplantation in the Treatment of HCC
A Phase 4 study testing DEB-TACE in people with Liver Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to living donor liver transplantation can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- DEB-TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2024to 1 Jul 2027
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years;
- Subjects with viral hepatitis or cirrhosis are clinically diagnosed according to AASLD standards, which require a history of viral hepatitis or cirrhosis combined with imaging examinations (enhanced CT, MRI, second-generation ultrasound contrast agents). When the tumor diameter is greater than 2 cm, a diagnosis can be made if one imaging technique shows typical arterial phase rapid enhancement and rapid washout. If the diameter is 1-2 cm, two imaging techniques must confirm this, or one imaging technique confirms it and alpha-fetoprotein (AFP) is greater than 400 ng/ml. For subjects who cannot be clinically diagnosed, histological or cytological biopsy confirmation is required; original biopsy records can also be used for diagnosis.
- Child-Pugh score A-B grade;
- Tumor present in the right lobe of the liver;
- Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7;
- ECOG-PS score 0-1;
- Scheduled for living donor liver transplantation as the primary treatment;
- Signed informed consent form.
Who cannot join
- Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct;
- Severe hepatic encephalopathy;
- Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade III-IV);
- Severe contrast agent allergy;
- Irreversible hepatic artery to hepatic vein shunt;
- Special types of anatomical variations (Asan portal vein type III);
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- Extrahepatic metastatic tumors;
- Concurrent active hepatitis or severe infection;
- Tumor dissemination or distant metastasis, expected survival <3 months;
- Renal dysfunction, creatinine >176.8 umol/L or creatinine clearance rate <30ml/min;
- White blood cell count <3.0x109/L, platelet count <50x106/L, and unable to correct;
- Inability to tolerate surgical anesthesia (severe infection, cardiopulmonary insufficiency, cerebrovascular disease);
- Severe psychiatric illness;
- Other reasons deemed unsuitable for participation by the investigator.
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
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Kang Associate chief physician
About this study
Official title: A Prospective, Single Arm, Exploratory Study of Using Drug-eluting Beads Transarterial Chemoembolization Prior to Liver Transplantation in the Treatment of Hepatocellular Carcinoma
The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to living donor liver transplantation can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for living donor liver transplantation receive DEB-TACE 2 weeks prior to the surgery.
The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing living donor liver transplantation; 4) Adverse events related to DEB-TACE.
- Conditions
- Liver Cancer
- Being tested
- DEB-TACE
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACEProcedure or surgery
DEB-TACE, or Drug-Eluting Bead Transarterial Chemoembolization, is a minimally invasive interventional radiology procedure primarily used in the treatment of hepatocellular carcinoma (HCC), which is the most common type of liver cancer. This procedure combines two treatment modalities: transarterial chemoembolization (TACE) and the use of drug-eluting beads (DEB).
During DEB-TACE, tiny beads loaded with chemotherapy drugs are injected directly into the blood vessels supplying the tumor in the liver. These drug-eluting beads gradually release chemotherapy agents, delivering a targeted and sustained dose directly to the cancerous tissue while minimizing systemic side effects. Additionally, the beads themselves act as embolic agents, blocking the blood flow to the tumor and causing ischemia, which further contributes to the destruction of the tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| DEB-TACE prior to living donor liver transplantation | Experimental | Patients with HCC scheduled for living donor liver transplantation treatment receive DEB-TACE 2 weeks prior to the surgery Receives: Procedure: DEB-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
the time from DEB-TACE treatment until tumor recurrence in the original site, transplanted liver, other tissues and organs, or death, whichever occurs first.
Measured: 2 years
Secondary outcomes (4)
Overall survival (OS)
the time from DEB-TACE treatment until death from any cause.
Measured: 5 years
Pathological response rate (Pathological Response)
at the time of the surgery
Measured: 1 year
Proportion of patients completing living donor liver transplantation
1 year
Measured: at the time of the surgery
Adverse events related to DEB-TACE
2 weeks
Measured: from DEB-TACE to the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start16 Oct 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Kang He, RenJi Hospital
- Investigators
- Jianjun Zhang, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353126
- Sponsor's protocol ID
- DTACELT
- Status last verified
- Oct 2024
- First submitted
- 28 Mar 2024
- Last updated
- 18 Oct 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Exploratory Study of Using Drug-eluting Beads Transarterial Chemoembolization Prior to Liver Transplantation in the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06353126
- Acronym / sponsor ID
- DTACELT
- Conditions
- Liver Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Apr 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.
The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to living donor liver transplantation can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for living donor liver transplantation receive DEB-TACE 2 weeks prior to the surgery.
The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing living donor liver transplantation; 4) Adverse events related to DEB-TACE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE prior to living donor liver transplantation | Experimental | Procedure: DEB-TACEPatients with HCC scheduled for living donor liver transplantation treatment receive DEB-TACE 2 weeks prior to the surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years;
- Subjects with viral hepatitis or cirrhosis are clinically diagnosed according to AASLD standards, which require a history of viral hepatitis or cirrhosis combined with imaging examinations (enhanced CT, MRI, second-generation ultrasound contrast agents). When the tumor diameter is greater than 2 cm, a diagnosis can be made if one imaging technique shows typical arterial phase rapid enhancement and rapid washout. If the diameter is 1-2 cm, two imaging techniques must confirm this, or one imaging technique confirms it and alpha-fetoprotein (AFP) is greater than 400 ng/ml. For subjects who cannot be clinically diagnosed, histological or cytological biopsy confirmation is required; original biopsy records can also be used for diagnosis.
- Child-Pugh score A-B grade;
- Tumor present in the right lobe of the liver;
- Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7;
Key exclusion criteria (14 listed)
- Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct;
- Severe hepatic encephalopathy;
- Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade III-IV);
- Severe contrast agent allergy;
- Irreversible hepatic artery to hepatic vein shunt;
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-TACEDEB-TACE, or Drug-Eluting Bead Transarterial Chemoembolization, is a minimally invasive interventional radiology procedure primarily used in the treatment of hepatocellular carcinoma (HCC), which is the most common type of liver cancer. This procedure combines two treatment modalities: transarterial chemoembolization (TACE) and the use of drug-eluting beads (DEB). During DEB-TACE, tiny beads loaded with chemotherapy drugs are injected directly into the blood vessels supplying the tumor in the liver. These drug-eluting beads gradually release chemotherapy agents, delivering a targeted and sustained dose directly to the cancerous tissue while minimizing systemic side effects. Additionally, the beads themselves act as embolic agents, blocking the blood flow to the tumor and causing ischemia, which further contributes to the destruction of the tumor cells. | Procedure or surgery | DEB-TACE prior to living donor liver transplantation |
Primary outcome
Recurrence-free survival (RFS)
Time frame: 2 years
the time from DEB-TACE treatment until tumor recurrence in the original site, transplanted liver, other tissues and organs, or death, whichever occurs first.
4 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Pathological response rate (Pathological Response)
Time frame: 1 year
Proportion of patients completing living donor liver transplantation
Time frame: at the time of the surgery
Adverse events related to DEB-TACE
Time frame: from DEB-TACE to the surgery
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 18 Oct 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.
Jianjun Zhang, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEB-TACE in people with Liver Cancer, run by RenJi 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 8 inclusion and 14 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 18 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Kang He (13621621415, hekang@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: 2 years). 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 18 Oct 2024.