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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03783559

Enrollment

168

Registered

2018-12-21

Start date

2016-01-31

Completion date

2021-03-31

Last updated

2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenocarcinoma Metastatic to the Liver

Keywords

colorectal cancer liver metastasis, Transarterial chemoembolization, conversion resection rates, chemotherapy

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.

Interventions

DRUGTACE

TACE

DRUGchemotherapy±target therapy

chemotherapy±target therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Progression free survival	6 months

Secondary

Measure	Time frame
overall survival	6 months
conversion resection rates	2-4months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026