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

Tianjin Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Colon Cancer Liver Metastasis

Treatments: Drug: Irinotecan; Procedure: TACE; Device: eluting-bead

Study type: Interventional

Funder types: Other

Identifiers

NCT03175016

TMU-CIH-IR-006

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.
11. Other conditions place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

DEBIRI

Experimental group

Description:

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

Treatment:

Drug: Irinotecan

Procedure: TACE

Device: eluting-bead