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

Primary Purpose

Colon Cancer Liver Metastasis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TACE
Irinotecan
eluting-bead
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer Liver Metastasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DEBIRI

Arm Description

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

Outcomes

Primary Outcome Measures

Tumor Response of two months
Response rate(RR)
Tumor Response of four months
Response rate(RR)
Tumor Response of six months
Response rate(RR)

Secondary Outcome Measures

overall survival
overall survival(OS)
Time to intrahepatic progression
Time to intrahepatic progression(THP)
Time to extrahepatic progression
Time to extrahepatic progression(TEP)
Quality of life
Assesment Quality of life by EORTC QOL-C30 questionnaire

Full Information

First Posted
May 28, 2017
Last Updated
June 25, 2017
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03175016
Brief Title
Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer
Acronym
DEBIRI-CRLM
Official Title
Irinotecan-Eluting Bead (DEBIRI) for Unresectable Liver Metastases From Colorectal Cancer After Systemic Chemotherapy Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Liver Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEBIRI
Arm Type
Experimental
Arm Description
Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
Transcatheter arterial chemoembolization
Intervention Description
Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
eluting-bead
Intervention Description
The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.
Primary Outcome Measure Information:
Title
Tumor Response of two months
Description
Response rate(RR)
Time Frame
Two months post first treatment
Title
Tumor Response of four months
Description
Response rate(RR)
Time Frame
four months post first treatment
Title
Tumor Response of six months
Description
Response rate(RR)
Time Frame
Six months post first treatment
Secondary Outcome Measure Information:
Title
overall survival
Description
overall survival(OS)
Time Frame
From date of first treatment until the date of death from any cause, whichever came first, assessed up to 24 months
Title
Time to intrahepatic progression
Description
Time to intrahepatic progression(THP)
Time Frame
From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months
Title
Time to extrahepatic progression
Description
Time to extrahepatic progression(TEP)
Time Frame
From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months
Title
Quality of life
Description
Assesment Quality of life by EORTC QOL-C30 questionnaire
Time Frame
Six months post first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Guo, PhD
Phone
13920076145
Email
cjr.guozhi@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xueling Yang, PhD
Phone
15620930669
Email
yxueling123@163.com
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Guo, MD
Phone
13920076145
Email
cjr.guozhi@vip.163.com
First Name & Middle Initial & Last Name & Degree
Xueling Yang, MD
Phone
15620930669
Email
yxueling123@163.com
First Name & Middle Initial & Last Name & Degree
Wenge Xing

12. IPD Sharing Statement

Plan to Share IPD
No

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

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