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

Phase 3

• Conditions: Colorectal Adenocarcinoma Metastatic to the Liver
• Interventions: Drug: TACE; Drug: chemotherapy±target therapy

• Registration Number: NCT03783559
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-12
• Study First Submitted: 2018-12-15
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-21
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	chemotherapy±target therapy	TACE plus chemotherapy ± target therapy
Arm B	chemotherapy±target therapy	chemotherapy ± target therapy
Arm A	TACE	TACE plus chemotherapy ± target therapy

Primary Outcome Measures

Name	Time	Method
Progression free survival	6 months

Secondary Outcome Measures

Name	Time	Method
overall survival	6 months
conversion resection rates	2-4months

Trial Locations

Locations (1)

Department of General Surgery, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China