Clinical trial NCT03175016: Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer
Official title: Irinotecan-Eluting Bead (DEBIRI) for Unresectable Liver Metastases From Colorectal Cancer After Systemic Chemotherapy Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colon Cancer Liver Metastasis
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tumor Response of two months
timeFrame: Two months post first treatment
measure: Tumor Response of four months
timeFrame: four months post first treatment
measure: Tumor Response of six months
timeFrame: Six months post first treatment
Secondary outcomes:
measure: overall survival
timeFrame: From date of first treatment until the date of death from any cause, whichever came first, assessed up to 24 months
measure: Time to intrahepatic progression
timeFrame: From date of first treatment until the date of intrahepatic progression, whichever came first, assessed up to 24 months
measure: Time to extrahepatic progression
timeFrame: From date of first treatment until the date of extrahepatic progression, whichever came first, assessed up to 24 months
measure: Quality of life
timeFrame: Six months post first treatment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: