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

June 25, 2017 updated by: Tianjin Medical University Cancer Institute and Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
        • Sub-Investigator:
          • Wenge Xing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DEBIRI
Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)
Procedure: TACE
Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply.
Other Names:
  • Transcatheter arterial chemoembolization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Response of two months
Time Frame: Two months post first treatment
Response rate(RR)
Two months post first treatment
Tumor Response of four months
Time Frame: four months post first treatment
Response rate(RR)
four months post first treatment
Tumor Response of six months
Time Frame: Six months post first treatment
Response rate(RR)
Six months post first treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2017

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (ACTUAL)

June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU-CIH-IR-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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