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Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine as postoperative adjuvant therapy in patients with colorectal cancer liver metastases after radical resection. Eligible participants must have histologically confirmed colorectal cancer liver metastases and have completed radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment. Postoperative imaging must show no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease. Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine every 21 days for 2 to 4 cycles. After 2 cycles, treatment continuation will be determined by the investigator based on efficacy and tolerability.
Official title: An Exploratory Clinical Study of Hepatic Arterial Infusion of Liposomal Irinotecan Combined With Oxaliplatin and Capecitabine as Postoperative Adjuvant Therapy for Colorectal Cancer Liver Metastases
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2026-05-30
Completion Date
2032-05-30
Last Updated
2026-05-06
Healthy Volunteers
No
Interventions
Liposomal Irinotecan
Liposomal irinotecan 50 mg/m\^2 will be administered by hepatic arterial infusion over 90 minutes on Day 1 of each 21-day cycle.
Oxaliplatin
Oxaliplatin 100 mg/m\^2 will be administered by intravenous infusion on Day 1 of each 21-day cycle.
Capecitabine
Capecitabine 1000 mg/m\^2 will be administered orally twice daily on Days 1 to 14 of each 21-day cycle.
hepatic arterial infusion chemotherapy (HAIC)
Hepatic arterial infusion chemotherapy will be performed to deliver liposomal irinotecan directly through the hepatic artery as part of postoperative adjuvant treatment.