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

Phase 2

• Conditions: Colon Cancer Liver Metastasis
• Interventions: Procedure: TACE; Drug: Irinotecan; Device: eluting-bead

• Registration Number: NCT03175016
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-28
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Study Start: 2017-06-20
• Last Update Submitted: 2017-06-25
• Last Update Posted: 2017-06-27
• Primary Completion: 2019-08
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Tumor Response of four months	four months post first treatment	Response rate(RR)
Tumor Response of two months	Two months post first treatment	Response rate(RR)
Tumor Response of six months	Six months post first treatment	Response rate(RR)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China