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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Camptothecin; Irinotecan

Criteria

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.