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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-03-31

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.

Detailed Description

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Conditions

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Colorectal Adenocarcinoma Metastatic to the Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

TACE plus chemotherapy ± target therapy

Group Type EXPERIMENTAL

TACE

Intervention Type DRUG

TACE

chemotherapy±target therapy

Intervention Type DRUG

chemotherapy±target therapy

Arm B

chemotherapy ± target therapy

Group Type ACTIVE_COMPARATOR

chemotherapy±target therapy

Intervention Type DRUG

chemotherapy±target therapy

Interventions

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TACE

TACE

Intervention Type DRUG

chemotherapy±target therapy

chemotherapy±target therapy

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xu jianmin

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 33611431 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32163181 (View on PubMed)

Other Identifiers

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TACECRLM

Identifier Type: -

Identifier Source: org_study_id

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