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.
Colorectal cancer commonly metastasizes to the liver, and recurrence after radical resection of colorectal cancer liver metastases remains frequent, particularly in the liver. Systemic adjuvant chemotherapy is commonly used after resection to eliminate potential micrometastatic disease; however, systemic chemotherapy may have limited local efficacy in the liver and may be associated with systemic toxicity. Hepatic arterial infusion chemotherapy delivers chemotherapy directly into the hepatic arterial supply. Because liver tumors are mainly supplied by the hepatic artery, this approach may increase local drug concentration in the liver while reducing systemic exposure. Liposomal irinotecan is a liposomal formulation of irinotecan designed to improve drug stability, prolong circulation, enhance tumor accumulation, and potentially reduce systemic toxicity. This study will explore whether hepatic arterial infusion of liposomal irinotecan combined with systemic oxaliplatin and capecitabine can improve disease-free survival and hepatic recurrence-free survival while maintaining an acceptable safety profile in patients at high risk of hepatic recurrence after radical resection of colorectal cancer liver metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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 100 mg/m\^2 will be administered by intravenous infusion on Day 1 of each 21-day cycle.
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 will be performed to deliver liposomal irinotecan directly through the hepatic artery as part of postoperative adjuvant treatment.
3-Year Disease-Free Survival Rate
The 3-year disease-free survival rate is defined as the proportion of participants who remain free of tumor recurrence, metastasis, or disease progression at 3 years after initiation of study treatment.
Time frame: 3 years from initiation of study treatment.
Overall Survival
Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive at the end of the study will be censored at the date they were last known to be alive.
Time frame: From enrollment to death from any cause, assessed for up to 3 years.
Hepatic Recurrence-Free Survival
Hepatic recurrence-free survival is defined as the time interval from completion of study treatment to the first recurrence of tumor in the liver.
Time frame: From completion of study treatment to first hepatic recurrence, assessed for up to 3 years.
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence and severity of adverse events, including overall adverse events, adverse events by grade, Grade 3 or higher adverse events, and serious adverse events. Adverse events will be graded according to NCI CTCAE version 5.0.
Time frame: From the first dose of study treatment through the end-of-treatment visit and follow-up period, assessed for up to 3 years.
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