Back to resultsTACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)
Primary Purpose
Colorectal Adenocarcinoma Metastatic to the Liver
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TACE
chemotherapy±target therapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Adenocarcinoma Metastatic to the Liver focused on measuring colorectal cancer liver metastasis, Transarterial chemoembolization, conversion resection rates, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically confirmed CRLM
- 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:
- pregnant or lactating women
- patients with severe organ dysfunction or failure
- with severe cardiovascular or mental disease
Sites / Locations
- Department of General Surgery, Zhongshan Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
TACE plus chemotherapy ± target therapy
chemotherapy ± target therapy
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
overall survival
conversion resection rates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03783559
Brief Title
TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)
Official Title
TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To date no randomized controlled trials have been completed that demonstrated whether TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for patients who failed with first-line chemotherapy.The primary objective of this trial is to determine conversion resection rates and survival for patients with colorectal cancer liver metastasis are treated with TACE plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd line.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenocarcinoma Metastatic to the Liver
Keywords
colorectal cancer liver metastasis, Transarterial chemoembolization, conversion resection rates, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
TACE plus chemotherapy ± target therapy
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
chemotherapy ± target therapy
Intervention Type
Drug
Intervention Name(s)
TACE
Intervention Description
TACE
Intervention Type
Drug
Intervention Name(s)
chemotherapy±target therapy
Intervention Description
chemotherapy±target therapy
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
6 months
Title
conversion resection rates
Time Frame
2-4months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically confirmed CRLM
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:
pregnant or lactating women
patients with severe organ dysfunction or failure
with severe cardiovascular or mental disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, PhD
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of General Surgery, Zhongshan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33611431
Citation
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.
Results Reference
derived
PubMed Identifier
32163181
Citation
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.
Results Reference
derived
Learn more about this trial
TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)
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