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NOT YET RECRUITING
NCT07570914
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

Oxaliplatin

Oxaliplatin 100 mg/m\^2 will be administered by intravenous infusion on Day 1 of each 21-day cycle.

DRUG

Capecitabine

Capecitabine 1000 mg/m\^2 will be administered orally twice daily on Days 1 to 14 of each 21-day cycle.

PROCEDURE

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.