Clinical Trials/NCT03175016

NCT03175016

Unknown

Phase 2

Irinotecan-Eluting Bead (DEBIRI) for Unresectable Liver Metastases From Colorectal Cancer After Systemic Chemotherapy Failure

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country200 target enrollmentJune 20, 2017

ConditionsColon Cancer Liver Metastasis

InterventionsTACE Irinotecan eluting-bead

DrugsIrinotecan

Overview

Phase: Phase 2
Intervention: TACE
Conditions: Colon Cancer Liver Metastasis
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 200
Locations: 1
Primary Endpoint: Tumor Response of four months
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicentre, open labeled, single arm study to determine effectiveness and safety of chemoembolization with Irinotecan-Eluting Bead(DEBIRI) in the treatment of unresectable liver metastases in patients with colorectal cancer after chemotherapy failure.

Registry

clinicaltrials.gov

Start Date

June 20, 2017

End Date

December 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
•Patients with primary colorectal lesions removed, and negative extrahepatic metastasis
•Patients with at least one measurable liver metastases, with size \> 2cm or less than 5 liver metastases,with size smaller than 10cm.
•Patients have received at least six cycle system chemotherapy based irinotecan or oxaliplatin and got a failure outcome; or patients who are intolerance of operation.
•No intervention therapy was received for liver lesions during one year.
•Life expectancy of \> 3 months
•Child-pugh's grade A or B (no more than 7 score).
•Eastern Cooperative Oncology Group (ECOG) Performance Status score of \< 2
•Signed, written informed consent

Exclusion Criteria

•Patients with extrahepatic metastasis
•Patients has received TACE,ablation and iodine seed implantation for liver lesions during one year.
•With obvious arterio-venous fistula
•Patients suffered with other cancer(Except for cured basal or squamous cell skin cancer or cervical carcinoma in situ)
•Hematologic function: leukocytes \<3000cell/mm3, platelets\<50000/mm3, with no hypersplenism.
•Adequate renal function (creatinine ≤ 2.0mg/dl)
•Alanine transaminase(ALT) and/or glutamic oxalacetic transaminase(AST) \>5 times upper limit of normal(ULN)
•International Normalized Ratio (INR) \>1.5, or being treated by anticoagulants, or being suffered hemorrhagic disease.
•With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
•With recent infections and received antibiotics.

Arms & Interventions

DEBIRI

Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)

Intervention: TACE

DEBIRI

Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)

Intervention: Irinotecan

DEBIRI

Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)

Intervention: eluting-bead

Outcomes

Primary Outcomes

Tumor Response of four months

Time Frame: four months post first treatment

Response rate(RR)

Tumor Response of two months

Time Frame: Two months post first treatment

Response rate(RR)

Tumor Response of six months

Time Frame: Six months post first treatment

Response rate(RR)

Secondary Outcomes

Time to intrahepatic progression(From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months)
Time to extrahepatic progression(From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months)
overall survival(From date of first treatment until the date of death from any cause, whichever came first, assessed up to 24 months)
Quality of life(Six months post first treatment)