Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer
NCT ID: NCT03175016
Last Updated: 2017-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2017-06-20
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DEBIRI
Transcatheter arterial chemoembolization(TACE) with Irinotecan eluting-bead(DEBIRI)
TACE
Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply.
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.
eluting-bead
The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.
Interventions
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TACE
Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply.
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.
eluting-bead
The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TMU-CIH-IR-006
Identifier Type: -
Identifier Source: org_study_id
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