drugset / Trial / NCT07570914

Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases

NCT07570914

Phase 2 Not yet recruiting 28 enrolled Tianjin Medical University Cancer Institute and Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-30
Primary completion
2027-05-30
Completion
2032-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Irinotecan Small molecule 50 mg/m2 Other
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous