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Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer

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

NCT03175016•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Patients with primary colorectal lesions removed, and negative extrahepatic metastasis
•3. Patients with at least one measurable liver metastases, with size \> 2cm or less than 5 liver metastases,with size smaller than 10cm.
•4. 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.
•5. No intervention therapy was received for liver lesions during one year.
•6. Life expectancy of \> 3 months
•7. Child-pugh's grade A or B (no more than 7 score).
•8. Eastern Cooperative Oncology Group (ECOG) Performance Status score of \< 2
•9. Signed, written informed consent

Exclusion Criteria

•1. Patients with extrahepatic metastasis
•2. Patients has received TACE,ablation and iodine seed implantation for liver lesions during one year.
•3. With obvious arterio-venous fistula
•4. Patients suffered with other cancer(Except for cured basal or squamous cell skin cancer or cervical carcinoma in situ)
•5. Hematologic function: leukocytes \<3000cell/mm3, platelets\<50000/mm3, with no hypersplenism.
•6. Adequate renal function (creatinine ≤ 2.0mg/dl)
•7. Alanine transaminase(ALT) and/or glutamic oxalacetic transaminase(AST) \>5 times upper limit of normal(ULN)
•8. International Normalized Ratio (INR) \>1.5, or being treated by anticoagulants, or being suffered hemorrhagic disease.
•9. With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
•10. With recent infections and received antibiotics.
+1 more criteria

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

June 20, 2017

Primary Completion Date

August 1, 2019

Completion Date

December 1, 2019

Last Updated

June 27, 2017

Enrollment

200

ESTIMATED participants

Conditions

Colon Cancer Liver Metastasis

Interventions

TACE

PROCEDURE

Irinotecan

DRUG

eluting-bead

DEVICE

Contacts

Zhi Guo, PhD

CONTACT

13920076145 cjr.guozhi@vip.163.com

Xueling Yang, PhD

CONTACT

15620930669 yxueling123@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

Argipressin's Influence on Blood Loss During Hepatic Resection

Diffusion-Weighted MRI for Liver Metastasis

Safety of TACE With Oxaliplatin, Irinotecan and Raltitrexed for Refractory Colorectal Cancer Liver Metastasis