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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colon Cancer Liver Metastasis

Intervention / Treatment
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* Procedure: TACE
* Drug: Irinotecan
* Device: eluting-bead


Participation Criteria
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Eligibility Criteria
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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. Other conditions place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEBIRI<br>Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI) | Procedure: TACE<br>* Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply.<br>* Other names: Transcatheter arterial chemoembolization;Drug: Irinotecan<br>* Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in eluting-beads and injected in the tumor.<br>Device: eluting-bead<br>* The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response of two months | Response rate(RR) | Two months post first treatment | 
| Tumor Response of four months | Response rate(RR) | four months post first treatment | 
| Tumor Response of six months | Response rate(RR) | Six months post first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival(OS) | From date of first treatment until the date of death from any cause, whichever came first, assessed up to 24 months | 
| Time to intrahepatic progression | Time to intrahepatic progression(THP) | From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months | 
| Time to extrahepatic progression | Time to extrahepatic progression(TEP) | From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months | 
| Quality of life | Assesment Quality of life by EORTC QOL-C30 questionnaire | Six months post first treatment |