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

Colorectal Adenocarcinoma Metastatic to the Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03783559
• Other study ID #: TACECRLM
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: March 2021

Study information

• Verified date: June 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: March 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma Metastatic to the Liver

Intervention

Drug:
• TACE
TACE
• chemotherapy±target therapy
chemotherapy±target therapy

Locations

Country	Name	City	State
China	Department of General Surgery, Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		6 months
Secondary	overall survival		6 months
Secondary	conversion resection rates		2-4months