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

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Colorectal Adenocarcinoma Metastatic to the Liver

Treatments: Drug: chemotherapy±target therapy; Drug: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT03783559

TACECRLM

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Arm A

Experimental group

Description:

TACE plus chemotherapy ± target therapy

Treatment:

Drug: chemotherapy±target therapy

Drug: TACE

Arm B

Active Comparator group

Description:

chemotherapy ± target therapy

Treatment:

Drug: chemotherapy±target therapy