Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis

Colorectal Cancer Clinical Trial

Official title:

Trans-arterial Chemoembolization With Irinotecan Drug-eluting Beads Before Liver Surgery for Patients With Primary Unresectable Colorectal Liver Metastasis: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04912258
• Other study ID #: PIDUC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2021
• Source: Fudan University
• Contact: Jianmin Xu
• Phone: +8613501984869
• Email: xujmin[@]aiiyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age = 18 years;

• Histologically proven colorectal liver metastasis;

• With liver-dominant disease;

• Primarily evaluated as potentially resectable and conversed successfully

• Adequate hematologic function: absolute neutrophil count (ANC)=1.5×109/l, platelets=75×109/l, and international normalized ratio (INR) =1.3 (within 1 week prior to randomization)

• Adequate liver and renal function: total bilirubin =2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase = 5x upper limit of normal, and albumin=2.5 g/dl, serum creatinine=2.0 mg/dl (within 1 week prior to randomization);

• Written informed consent for participation in the trial.

Exclusion Criteria:

• Primarily evaluated as resectable

• Failed to converse

• Patients with known hypersensitivity reactions to any of the components of the study treatments.

• Pregnancy (absence confirmed by serum/urine ß-HCG) or breast-feeding

• Other previous malignancy within 5 years

• Known drug abuse/ alcohol abuse

• Legal incapacity or limited legal capacity

Related Conditions & MeSH terms

• Colorectal Cancer
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Trans arterial chemoembolization with Irinotecan Drug-eluting Beads
preoperative chemoembolization with Irinotecan Drug-eluting Beads

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver relapse-free survival	from liver surgery to liver relapse	6 months
Secondary	relapse-free survival		6 months
Secondary	overall survival		12 months
Secondary	response rate		2 months