TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)

Study Overview
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Brief Summary
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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.

Official Title
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TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy

Conditions
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Colorectal Adenocarcinoma Metastatic to the Liver

Intervention / Treatment
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* Drug: TACE
* Drug: chemotherapy±target therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>TACE plus chemotherapy ± target therapy | Drug: TACE<br>* TACE<br>Drug: chemotherapy±target therapy<br>* chemotherapy±target therapy<br>|
| Active Comparator: Arm B<br>chemotherapy ± target therapy | Drug: chemotherapy±target therapy<br>* chemotherapy±target therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 6 months | 
| conversion resection rates |  | 2-4months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer liver metastasis, Transarterial chemoembolization, conversion resection rates, chemotherapy