Hepatocellular Carcinoma Non-resectableNCT04967482
DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC
A study testing Drug-eluting bead transarterial chemoembolization (DEB-TACE) and Conventional transarterial chemoembolization (cTACE) in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Drug-eluting bead transarterial chemoembolization (DEB-TACE) and Conventional transarterial chemoembolization (cTACE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2021to 8 Jul 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically.
- The tumor lesion was only localized in one liver lobe.
- Large HCC with single lesion > 7 cm, or multiple lesions.
- unresectable HCC evaluated by the surgeon team.
- The patient is suitable for TACE treatment, which is evaluated by MDT.
- At least one measurable intrahepatic target lesion.
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- Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
- ECOG score of performance status ≤ 1 point.
- Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×109/L, absolute value of neutrophils >1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range.
- Patients have the willingness to receive TACE as the conversion therapy for surgical resection.
Who cannot join
- Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein.
- Accompanied with hepatic vein and vena cava tumor thrombus.
- The extent of the lesion exceeds one liver lobe or extrahepatic metastasis.
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy.
- History of other malignancies.
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- Uncontrollable infection.
- Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA <10^3 IU/mL.
- HCV patients need to complete the anti-HCV therapy before they are enrolled.
- History of HIV.
- Allergic to the drugs involved in the research.
- Patients with gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3.
- History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy
- Those with bleeding tendency.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Mingyue Cai, Dr., +86-20-34156205, cai020@yeah.net
About this study
Official title: Drug-eluting Bead Transarterial Chemoembolization Compared With Conventional Transarterial Chemoembolization as the Conversion Therapy for Unresectable Large Hepatocellular Carcinoma: a Multicenter, Prospective, Nonrandomized Study
This study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC).
Read the detailed description
This is a multicenter, prospective and nonrandomized study to evaluate the efficacy of DEB-TACE (with DC Bead) compared with cTACE as the conversion therapy for unresectable large HCC.
At least 216 patients (≥ 108 patients in each arm) with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE or cTACE as the primary treatment according to their won will. TACE can be repeated on demand based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team, and the technique method of each TACE procedure (i.e. DEB-TACE or cTACE) for the same patient should be consistent. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.
The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR) of TACE, progression-free survival (PFS), times of TACE procedure to achieve conversion, conversion time, success rate of surgical resection, tumor recurrence rate after resection, tumor-free survival (TFS) of patients who undergo surgical resection, adverse events (AEs) and overall survival (OS).
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- Drug-eluting bead transarterial chemoembolization (DEB-TACE), Conventional transarterial chemoembolization (cTACE)
- Keywords
- Hepatocellular carcinoma, Transarterial chemoembolization, Conversion therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting bead transarterial chemoembolization (DEB-TACE)Procedure or surgery
The patients will receive DEB-TACE if they choose DEB-TACE as the primary treatment. DC Bead loaded with epirubicin (1 vial of DC Bead loaded with 60 mg of epirubicin) is used for chemoembolization. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. DEB-TACE) for the same patient should be consistent.
Conventional transarterial chemoembolization (cTACE)Procedure or surgery
The patients will receive cTACE if they choose cTACE as the primary treatment. An emulsion of epirubicin in lipiodol wiil be injected into the tumor feeding artery. Afterwards, microspheres or polyvinyl alcohol particles mixed with contrast agent will be administered intraarterially until arterial flow stasis was achieved. Generally, the dose of lipiodol and epirubicin should not exceed 30 mL and 60 mg for each procedure. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. cTACE) for the same patient should be consistent.
| Study group | Role | What they receive |
|---|---|---|
| DEB-TACE | Experimental | DEB-TACE will be performed for the patients who choose DEB-TACE as the primary treatment. Receives: Procedure: Drug-eluting bead transarterial chemoembolization (DEB-TACE) |
| cTACE | Active comparator | cTACE will be performed for the patients who choose cTACE as the primary treatment. Receives: Procedure: Conventional transarterial chemoembolization (cTACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of conversion to resection
The proportion of patients with initially unresectable large HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after TACE treatment.
Measured: 2 years.
Secondary outcomes (7)
Objective response rate (ORR) of TACE treatment
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) which is assessed by the investigators according to modified Response Evaluaion Criteria in Solid Tumors (mRECIST).
Measured: 2 years.
Progression-free survival (PFS)
The time between the first TACE treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first. For the patients who receive surgical resection after TACE, PD is defined as tumor recurrence/metastasis after resection. For the patients who did not undergo surgical resection, PD is assessed by the investigators according to mRECIST.
Measured: 3 years.
Times of TACE procedure to achieve conversion
The number of TACE procedures performed for the patients when thier tumors become resectable. Resectability of the tumor is assessed by MDT during follow-up.
Measured: 2 years.
Time for successful conversion
The duration between the first TACE treatment and the resectability of the tumor. Resectability is assessed by MDT.
Measured: 2 years.
Disease-free survival (TFS) of the patients who undergo resection
The time between surgical resection and the first tumor recurrence/metastasis or death from any cause, whichever occurs first..
Measured: 2 years.
Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Measured: 3 years.
Overall survival (OS)
The time from first TACE until the date of death from any cause.
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start9 Jul 2021
- Primary completion8 Jul 2024 (estimated)
- Study completion8 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967482
- Sponsor's protocol ID
- MIIR-06
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2021
- Last updated
- 15 Sep 2022
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-eluting Bead Transarterial Chemoembolization Compared With Conventional Transarterial Chemoembolization as the Conversion Therapy for Unresectable Large Hepatocellular Carcinoma: a Multicenter, Prospective, Nonrandomized Study
- ClinicalTrials.gov ID
- NCT04967482
- Acronym / sponsor ID
- MIIR-06
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- Hepatocellular carcinoma, Transarterial chemoembolization, Conversion therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 8 Jul 2024 (estimated)
- Study completion
- 8 Jul 2024 (estimated)
- First posted
- 19 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.
This study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC).
Detailed description
This is a multicenter, prospective and nonrandomized study to evaluate the efficacy of DEB-TACE (with DC Bead) compared with cTACE as the conversion therapy for unresectable large HCC.
At least 216 patients (≥ 108 patients in each arm) with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE or cTACE as the primary treatment according to their won will. TACE can be repeated on demand based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team, and the technique method of each TACE procedure (i.e. DEB-TACE or cTACE) for the same patient should be consistent. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.
The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR) of TACE, progression-free survival (PFS), times of TACE procedure to achieve conversion, conversion time, success rate of surgical resection, tumor recurrence rate after resection, tumor-free survival (TFS) of patients who undergo surgical resection, adverse events (AEs) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE | Experimental | Procedure: Drug-eluting bead transarterial chemoembolization (DEB-TACE)DEB-TACE will be performed for the patients who choose DEB-TACE as the primary treatment. |
| cTACE | Active comparator | Procedure: Conventional transarterial chemoembolization (cTACE)cTACE will be performed for the patients who choose cTACE as the primary treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically.
- The tumor lesion was only localized in one liver lobe.
- Large HCC with single lesion > 7 cm, or multiple lesions.
- unresectable HCC evaluated by the surgeon team.
- The patient is suitable for TACE treatment, which is evaluated by MDT.
Key exclusion criteria (14 listed)
- Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein.
- Accompanied with hepatic vein and vena cava tumor thrombus.
- The extent of the lesion exceeds one liver lobe or extrahepatic metastasis.
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy.
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 |
|---|---|---|
| Drug-eluting bead transarterial chemoembolization (DEB-TACE)The patients will receive DEB-TACE if they choose DEB-TACE as the primary treatment. DC Bead loaded with epirubicin (1 vial of DC Bead loaded with 60 mg of epirubicin) is used for chemoembolization. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. DEB-TACE) for the same patient should be consistent. | Procedure or surgery | DEB-TACE |
| Conventional transarterial chemoembolization (cTACE)The patients will receive cTACE if they choose cTACE as the primary treatment. An emulsion of epirubicin in lipiodol wiil be injected into the tumor feeding artery. Afterwards, microspheres or polyvinyl alcohol particles mixed with contrast agent will be administered intraarterially until arterial flow stasis was achieved. Generally, the dose of lipiodol and epirubicin should not exceed 30 mL and 60 mg for each procedure. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. cTACE) for the same patient should be consistent. | Procedure or surgery | cTACE |
Primary outcome
Success rate of conversion to resection
Time frame: 2 years.
The proportion of patients with initially unresectable large HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after TACE treatment.
7 secondary outcomes
Objective response rate (ORR) of TACE treatment
Time frame: 2 years.
Progression-free survival (PFS)
Time frame: 3 years.
Times of TACE procedure to achieve conversion
Time frame: 2 years.
Time for successful conversion
Time frame: 2 years.
Disease-free survival (TFS) of the patients who undergo resection
Time frame: 2 years.
Adverse Events (AEs)
Time frame: 3 years.
Overall survival (OS)
Time frame: 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting bead transarterial chemoembolization (DEB-TACE) and Conventional transarterial chemoembolization (cTACE) in people with Hepatocellular Carcinoma Non-resectable, 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 10 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: status not confirmed, as of the sponsor's last update on 15 Sep 2022. 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 Mingyue Cai, Dr. (+86-20-34156205, cai020@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of conversion to resection (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 15 Sep 2022.