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

Colon Cancer Liver Metastasis Clinical Trial

— DEBIRI-CRLM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03175016
• Other study ID #: TMU-CIH-IR-006
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 28, 2017
• Last updated: June 25, 2017
• Start date: June 20, 2017
• Est. completion date: December 2019

Study information

• Verified date: May 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Zhi Guo, PhD
• Phone: 13920076145
• Email: cjr.guozhi[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• TACE
Transcatheter arterial chemoembolization(TACE)is a minimally invasive procedure performed to restrict a tumor's blood supply.

Drug:
• Irinotecan
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.

Device:
• eluting-bead
The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response of two months	Response rate(RR)	Two months post first treatment
Primary	Tumor Response of four months	Response rate(RR)	four months post first treatment
Primary	Tumor Response of six months	Response rate(RR)	Six months post first treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of life	Assesment Quality of life by EORTC QOL-C30 questionnaire	Six months post first treatment