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A prospective study of irinotecan drug-eluting beads (DEBIRI) combined with FOLFIRI in patients after failure of FOLFOX with colorectal liver metastases

A prospective study of irinotecan drug-eluting beads (DEBIRI) combined with FOLFIRI in patients after failure of FOLFOX with colorectal liver metastases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018694
Enrollment
Unknown
Registered
2018-10-04
Start date
2018-11-01
Completion date
Unknown
Last updated
2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Case Series:DEBIRI+FOLFIRI

Sponsors

Guangdong General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-75 years male and female, patients with colorectal liver metastases were diagnosed by histology or EASL imaging diagnostic criteria; 2. ECOG physical status score 30%; platelet count = 50×10^9/L; neutrophil count> 1.0X10^9/L; normal coagulation function; Cr<2mg/dl; AST/ALT, Bil, TP, ALB all within the normal range; 7. patients should follow the protocol requirements and sign informed consent; if not, families or statutory guardian should sign informed consent.

Exclusion criteria

Exclusion criteria: 1. liver cirrhosis, ascites, portal hypertension, major portal vein tumor thrombi; 2. extrahepatic metastases; 3. suffered from other malignant tumors in the past five years; 4. hypertensive crisis or hypertensive encephalopathy; 5. severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident and myocardial infarction (6 months before enrollment), uncontrolled hypertension after proper medication; unstable angina pectoris; congestive heart-failure (NYHA2-4); arrhythmia requires medication; 6. suffered from or physical examination indicated that central nervous system disease, inculding primary brain tumor, uncontrollable epilepsy after standard treatment, brain metastases and a history of stroke; 7. severe uncontrolled systemic complications such as infection or diabetes; 8. participated in other drug or device clinical trials within 4 weeks; 9. allergic to any of the drugs in the study; 10. allergic to the nonionic contrast medium; 11. pregnant or lactating woman; 12. fertile woman has not used or rejected effective non-hormonal birth control, including intrauterine contraceptive ring, barrier method combined with spermicidal gel or sterilization surgery; or man who is likely to give birth; 13. the complication or social environment that can cause the subject to fail to follow the study plan or even endanger the patient's safety.

Design outcomes

Primary

MeasureTime frame
DCR;

Secondary

MeasureTime frame
PFS;HPFS;OS;

Countries

China

Contacts

Public ContactXu Rongde

Guangdong General Hospital

57658474@qq.com+86 13922754606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026