Hepatocellular CarcinomaNCT03969576
Drug-eluting Bead Transarterial Chemoembolisation (DEB-TACE) Versus (VS) Conventional Transarterial Chemoembolisation (cTACE) for Unresectable Hepatocellualr Carcinoma (HCC)
A study testing DEB-TACE and cTACE in people with Hepatocellular Carcinoma, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
this multi-center prospective cohort study is to evaluate the efficacy and the safety of drug-eluting bead TACE compared with conventional TACE in terms of objective response in unresectable HCC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- DEB-TACE and cTACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2020to 15 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior informed consent
- Confirmed Diagnosis of HCC: a. Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria. HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria. b. Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory. Documentation of original biopsy for diagnosis is acceptable
- Patients with unresectable Barcelona Clinic Liver Cancer (BCLC) stage A and BCLC B, and all patients have a intermediate or high tumor burden (the diameter of largest tumor plus tumor number is more than 6)
- Child Pugh class A/B(7) class without decompensated liver cirrhosis.
- ECOG Performance Status 0 score
- At least one uni-dimensional lesion measurable by MRI or CT according to the RECIST 1.1 criteria
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- Male or female subject larger than 18 years of age
- Life expectance of at least 12 weeks.
- Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
- Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
- Hemoglobin > 9.0 g/dl
- Absolute neutrophil count (ANC) >1,500/mm3
- Platelet count≥50x109/L
- ALB≥28g/L
- Total bilirubin < 2 mg/dL
- Alanine aminotransferase(ALT) and aspartate aminotransferase(AST) < 5 x upper limit of normal
- Blood urea nitrogen(BUN) and creatinine < 1.5 x upper limit of normal
- International normalized ratio(INR) < 1.7, or prothrombin time（PT） < 4 seconds above control
Who cannot join
- Portal vein or any vascular invasion
- Presence of extra hepatic spread
- Presence of metastasis in biliary tract or obstruction of biliary tract
- Presence of metastasis in brain or presence of symptom of the brain metastasis but lack of further examination to exclude brain metastasis
- Poor blood supply for the liver tumor lesions; poor blood supply refers that the tumor lesions fail to show obvious contrast uptake in the arterial phase and washout in venous or late phases by CT scan or MRI
- Any contraindications for hepatic embolization procedures:
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- Known hepatofugal blood flow
- Known porto-systemic shunt
- Renal failure / insufficiency requiring hemo-or peritoneal dialysis
- History of cardiac disease:
- Congestive heart failure >New York Heart Association (NYHA) class 2
- Uncontrolled hypertension
- Known history of HIV infection
- Patients who have previously been receiving any treatments against HCC
- Active clinically serious infections (> grade 2 NCI-CTCAE Version 4.0), except for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
- Contraindication of Anthracyclines administration, such as Doxorubicin
- Concurrent with other cancer
- Pregnant or breast-feeding subjects
- Women of childbearing age did not take any contraceptive measures
- Clinically significant gastrointestinal bleeding within 12 weeks prior to start of study
- Major surgery within 3 weeks prior to start of study drug (e.g. thoracolaparotomy is not allowed, but noninvasive surgery, e.g. biopsy, is allowed)
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study
this multi-center prospective cohort study is to evaluate the efficacy and the safety of drug-eluting bead TACE compared with conventional TACE in terms of objective response in unresectable HCC
- Conditions
- Hepatocellular Carcinoma
- Being tested
- DEB-TACE, cTACE
- Keywords
- Hepatocellular Carcinoma, Drug-eluting bead transarterial chemoembolization, Conventional transarterial chemoembolization, Objective response
- 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-TACEProcedure or surgery
Also called drug-eluting bead transarterial chemoembolisation
Patients in the DEB-TACE group received a maximum dose of 4 ml of DC bead (diameter 75-500 um) loaded with a maximum dose of 150 mg of anthracyclines drugs, such as doxorubicin. The anticancer agents and the diameter of DC Bead for individual patient will be selected according to the common clinical practice of each center. Treatment endpoint consisted of stasis of flow within feeding vessel(s) or completed delivery of maximum single-session dose of 150 mg doxorubicin. TACE will be repeated "on demand" according to the radiological response.
cTACEProcedure or surgery
Also called conventional transarterial chemoembolisation
Patients in the cTACE group were treated with anthracyclines, such as doxorubicin, in a mixture of lipiodol. Administration of the anticancer in oil emulsion was followed by injection of embolic materials such as gelfoam or PVA particles until complete stasis in segmental or subsegmental arterial branches. the tumor-feeding vessels should be superselected whenever possible. The anticancer agents for individual patient will be selected according to the common clinical practice of each center. TACE will be repeated "on demand" according to the radiological response.
| Study group | Role | What they receive |
|---|---|---|
| DEB-TACE | Experimental | 172 subjects in this study group will be receive the treatment of drug-eluting bead TACE Receives: Procedure: DEB-TACE |
| cTACE | Active comparator | 172 subjects in this study group will be receive the treatment of conventional TACE Receives: Procedure: cTACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
the percentage of patients who achieved complete response (CR) and partial response (PR) as the best response, according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria
Measured: Tumor response will be assessed at week 4 and week 12 after initiation of treatment and thereafter every 8 weeks, up to 1 year
Secondary outcomes (6)
Overall survival
Overall survival (OS) is measured from the treatment start until all-cause death or the last follow-up date
Measured: The last patient has been on study for 1year
Time to progression
Time to progression is measured from the treatment start to the radiologically confirmed progression
Measured: The last patient has been on study for 1year
Adverse event
The terms and grade of adverse event will be present according to the Common Terminology Criteria for Adverse Event (CTCAE version 4.0)
Measured: The adverse event will be assessed during in hospital and every 4 weeks, up to 1year
Progression-free survival
Progression-free survival (PFS) is measured from the treatment start until all-cause death or untreatable progression (vascular invasion, extra hepatic spread, the Eastern Cooperative Oncology Group (ECOG) performance status >2, and Child-Pugh grade over C, but except hepatic new nodule)
Measured: The last patient has been on study for 1year
Time to response
Time to response (TTR) is measured from the treatment start to the firstly radiologically confirmed complete response or partial response.
Measured: The last patient has been on study for 1year
Duration of response
Duration of response (DOR) is measured from the first-time confirmed complete response or partial response to the date of radiological progression
Measured: The last patient has been on study for 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start15 Sep 2020 (estimated)
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Jun 2022 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969576
- Sponsor's protocol ID
- DEB-TACE-HCC
- Status last verified
- Feb 2020
- First submitted
- 29 May 2019
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03969576
- Acronym / sponsor ID
- DEB-TACE-HCC
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Drug-eluting bead transarterial chemoembolization, Conventional transarterial chemoembolization, Objective response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 31 May 2019 (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 multi-center prospective cohort study is to evaluate the efficacy and the safety of drug-eluting bead TACE compared with conventional TACE in terms of objective response in unresectable HCC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE | Experimental | Procedure: DEB-TACE172 subjects in this study group will be receive the treatment of drug-eluting bead TACE |
| cTACE | Active comparator | Procedure: cTACE172 subjects in this study group will be receive the treatment of conventional TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Prior informed consent
- Confirmed Diagnosis of HCC: a. Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria. HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria. b. Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory. Documentation of original biopsy for diagnosis is acceptable
- Patients with unresectable Barcelona Clinic Liver Cancer (BCLC) stage A and BCLC B, and all patients have a intermediate or high tumor burden (the diameter of largest tumor plus tumor number is more than 6)
- Child Pugh class A/B(7) class without decompensated liver cirrhosis.
- ECOG Performance Status 0 score
Key exclusion criteria (21 listed)
- Portal vein or any vascular invasion
- Presence of extra hepatic spread
- Presence of metastasis in biliary tract or obstruction of biliary tract
- Presence of metastasis in brain or presence of symptom of the brain metastasis but lack of further examination to exclude brain metastasis
- Poor blood supply for the liver tumor lesions; poor blood supply refers that the tumor lesions fail to show obvious contrast uptake in the arterial phase and washout in venous or late phases by CT scan or MRI
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-TACEAlso: drug-eluting bead transarterial chemoembolisationPatients in the DEB-TACE group received a maximum dose of 4 ml of DC bead (diameter 75-500 um) loaded with a maximum dose of 150 mg of anthracyclines drugs, such as doxorubicin. The anticancer agents and the diameter of DC Bead for individual patient will be selected according to the common clinical practice of each center. Treatment endpoint consisted of stasis of flow within feeding vessel(s) or completed delivery of maximum single-session dose of 150 mg doxorubicin. TACE will be repeated "on demand" according to the radiological response. | Procedure or surgery | DEB-TACE |
| cTACEAlso: conventional transarterial chemoembolisationPatients in the cTACE group were treated with anthracyclines, such as doxorubicin, in a mixture of lipiodol. Administration of the anticancer in oil emulsion was followed by injection of embolic materials such as gelfoam or PVA particles until complete stasis in segmental or subsegmental arterial branches. the tumor-feeding vessels should be superselected whenever possible. The anticancer agents for individual patient will be selected according to the common clinical practice of each center. TACE will be repeated "on demand" according to the radiological response. | Procedure or surgery | cTACE |
Primary outcome
Objective response rate
Time frame: Tumor response will be assessed at week 4 and week 12 after initiation of treatment and thereafter every 8 weeks, up to 1 year
the percentage of patients who achieved complete response (CR) and partial response (PR) as the best response, according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria
6 secondary outcomes
Overall survival
Time frame: The last patient has been on study for 1year
Time to progression
Time frame: The last patient has been on study for 1year
Adverse event
Time frame: The adverse event will be assessed during in hospital and every 4 weeks, up to 1year
Progression-free survival
Time frame: The last patient has been on study for 1year
Time to response
Time frame: The last patient has been on study for 1year
Duration of response
Time frame: The last patient has been on study for 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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 DEB-TACE and cTACE in people with Hepatocellular Carcinoma, run by Air Force Military Medical University, China 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 18 inclusion and 21 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 5 Feb 2020. 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 Guohong Han, MD PHD (+86-2984771528, hangh@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Tumor response will be assessed at week 4 and week 12 after initiation of treatment and thereafter every 8 weeks, up to 1 year). 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 5 Feb 2020.