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

• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03175016
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.4
• Patients Per Site Per Month: 6.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Liver Metastasis	Procedure: TACE; Drug: Irinotecan; Device: eluting-bead	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Irinotecan-Eluting Bead (DEBIRI) for Unresectable Liver Metastases From Colorectal Cancer After Systemic Chemotherapy Failure
• Actual Study Start Date: Jun 20, 2017
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Tumor Response of two months [Two months post first treatment]

   Response rate(RR)

2. Tumor Response of four months [four months post first treatment]

   Response rate(RR)

3. Tumor Response of six months [Six months post first treatment]

   Response rate(RR)

Secondary Outcome Measures

1. 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)

2. 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)

3. 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)

4. Quality of life [Six months post first treatment]

   Assesment Quality of life by EORTC QOL-C30 questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin	China	300060

Sponsors and Collaborators

• Tianjin Medical University Cancer Institute and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tianjin Medical University Cancer Institute and Hospital
• ClinicalTrials.gov Identifier: NCT03175016
• Other Study ID Numbers: TMU-CIH-IR-006
• First Posted: Jun 5, 2017
• Last Update Posted: Jun 27, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis; Liver Neoplasms; Irinotecan

Study Results

No Results Posted as of Jun 27, 2017