Drug-eluting Bead Transarterial Chemoembolisation (DEB-TACE) Versus (VS) Conventional Transarterial Chemoembolisation (cTACE) for Unresectable Hepatocellualr Carcinoma (HCC)
Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study
1 other identifier
interventional
344
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hepatocellular-carcinoma
Started Sep 2020
Shorter than P25 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2022
CompletedFebruary 5, 2020
February 1, 2020
1.7 years
May 29, 2019
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
The last patient has been on study for 1year
Time to progression
The last patient has been on study for 1year
Adverse event
The adverse event will be assessed during in hospital and every 4 weeks, up to 1year
Progression-free survival
The last patient has been on study for 1year
Time to response
The last patient has been on study for 1year
- +1 more secondary outcomes
Study Arms (2)
DEB-TACE
EXPERIMENTAL172 subjects in this study group will be receive the treatment of drug-eluting bead TACE
cTACE
ACTIVE COMPARATOR172 subjects in this study group will be receive the treatment of conventional TACE
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
- +3 more criteria
You may not qualify if:
- 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:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 29, 2019
First Posted
May 31, 2019
Study Start
September 15, 2020
Primary Completion
June 15, 2022
Study Completion
June 15, 2022
Last Updated
February 5, 2020
Record last verified: 2020-02