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

NCT03783559 | Unknown Phase 3

• 1 other identifier: TACECRLM
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Adenocarcinoma Metastatic to the Liver

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  6 months

Secondary Outcomes (2)

• overall survival

  6 months

• conversion resection rates

  2-4months

Study Arms (2)

Arm A

EXPERIMENTAL

TACE plus chemotherapy ± target therapy

Drug: TACE; Drug: chemotherapy±target therapy

Arm B

ACTIVE COMPARATOR

chemotherapy ± target therapy

Drug: chemotherapy±target therapy

Interventions

TACE DRUG

TACE

Arm A

chemotherapy±target therapy DRUG

chemotherapy±target therapy

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant or lactating women
• patients with severe organ dysfunction or failure
• with severe cardiovascular or mental disease

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, 200032, China

Location

Related Publications (2)

• Liu Y, Chang W, Zhou B, Wei Y, Tang W, Liang F, Chen Y, Yan Z, Lv M, Ren L, Xu J. Conventional transarterial chemoembolization combined with systemic therapy versus systemic therapy alone as second-line treatment for unresectable colorectal liver metastases: randomized clinical trial. Br J Surg. 2021 Apr 30;108(4):373-379. doi: 10.1093/bjs/znaa155.

  PMID: 33611431 DERIVED

• Swierz MJ, Storman D, Riemsma RP, Wolff R, Mitus JW, Pedziwiatr M, Kleijnen J, Bala MM. Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases. Cochrane Database Syst Rev. 2020 Mar 12;3(3):CD009498. doi: 10.1002/14651858.CD009498.pub4.

  PMID: 32163181 DERIVED

Study Officials

• Jianmin Xu, PhD

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 21, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2021
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

CN (1)