TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)
NCT ID: NCT03783559
Last Updated: 2019-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
168 participants
INTERVENTIONAL
2016-01-31
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
TACE plus chemotherapy ± target therapy
TACE
TACE
chemotherapy±target therapy
chemotherapy±target therapy
Arm B
chemotherapy ± target therapy
chemotherapy±target therapy
chemotherapy±target therapy
Interventions
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TACE
TACE
chemotherapy±target therapy
chemotherapy±target therapy
Eligibility Criteria
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Inclusion Criteria
* disease limited to the liver Unresectable disease by surgery or other local therapies
* Age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2,child pugh A or B
* Expected survival ≥ 3 months
* Adequate hematological, hepatic and renal function
* PD(progressive disease) after first line chemotherapy
Exclusion Criteria
* patients with severe organ dysfunction or failure
* with severe cardiovascular or mental disease
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xu jianmin
Prof.
Principal Investigators
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Jianmin Xu, PhD
Role: STUDY_CHAIR
Fudan University
Locations
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Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai, , China
Countries
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References
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Liu Y, Chang W, Zhou B, Wei Y, Tang W, Liang F, Chen Y, Yan Z, Lv M, Ren L, Xu J. Conventional transarterial chemoembolization combined with systemic therapy versus systemic therapy alone as second-line treatment for unresectable colorectal liver metastases: randomized clinical trial. Br J Surg. 2021 Apr 30;108(4):373-379. doi: 10.1093/bjs/znaa155.
Swierz MJ, Storman D, Riemsma RP, Wolff R, Mitus JW, Pedziwiatr M, Kleijnen J, Bala MM. Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases. Cochrane Database Syst Rev. 2020 Mar 12;3(3):CD009498. doi: 10.1002/14651858.CD009498.pub4.
Other Identifiers
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TACECRLM
Identifier Type: -
Identifier Source: org_study_id
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