| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma | Procedure: DEB-TACE Procedure: cTACE | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 344 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study |
| Estimated Study Start Date : | September 15, 2020 |
| Estimated Primary Completion Date : | June 15, 2022 |
| Estimated Study Completion Date : | June 15, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: DEB-TACE
172 subjects in this study group will be receive the treatment of drug-eluting bead TACE
|
Procedure: DEB-TACE
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.
Other Name: drug-eluting bead transarterial chemoembolisation
|
|
Active Comparator: cTACE
172 subjects in this study group will be receive the treatment of conventional TACE
|
Procedure: cTACE
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.
Other Name: conventional transarterial chemoembolisation
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Any contraindications for hepatic embolization procedures:
History of cardiac disease:
| Contact: Guohong Han, MD PHD | +86-2984771528 | hangh@fmmu.edu.cn | |
| Contact: Dongdong Xia, MD | +86-2984771528 | xiadongdong1026@163.com |
| China, Shaanxi | |
| Xijing Hospital of Digestive Diseases, Fourth Military Medical University | |
| Xi'an, Shaanxi, China, 710032 | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 29, 2019 | ||||||||
| First Posted Date ICMJE | May 31, 2019 | ||||||||
| Last Update Posted Date | February 5, 2020 | ||||||||
| Estimated Study Start Date ICMJE | September 15, 2020 | ||||||||
| Estimated Primary Completion Date | June 15, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE |
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 mRECIST criteria
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Drug-eluting Bead Transarterial Chemoembolisation (DEB-TACE) Versus (VS) Conventional Transarterial Chemoembolisation (cTACE) for Unresectable Hepatocellualr Carcinoma (HCC) | ||||||||
| Official Title ICMJE | Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study | ||||||||
| 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 | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Hepatocellular Carcinoma | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
344 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 15, 2022 | ||||||||
| Estimated Primary Completion Date | June 15, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03969576 | ||||||||
| Other Study ID Numbers ICMJE | DEB-TACE-HCC | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Guohong Han, Air Force Military Medical University, China | ||||||||
| Study Sponsor ICMJE | Air Force Military Medical University, China | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Air Force Military Medical University, China | ||||||||
| Verification Date | February 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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