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

Last updated: June 11, 2019
Sponsor: Fudan University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT03783559
TACECRLM
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • pregnant or lactating women

  • patients with severe organ dysfunction or failure

  • with severe cardiovascular or mental disease

Study Design

Total Participants: 168
Study Start date:
January 01, 2016
Estimated Completion Date:
March 31, 2021

Connect with a study center

  • Department of General Surgery, Zhongshan Hospital, Fudan University

    Shanghai, 200032
    China

    Site Not Available

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