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
Study ID
NCT07570914
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan — DRUG
    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 — DRUG
    Oxaliplatin 100 mg/m\^2 will be administered by intravenous infusion on Day 1 of each 21-day cycle.
  • Capecitabine — DRUG
    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) — PROCEDURE
    Hepatic arterial infusion chemotherapy will be performed to deliver liposomal irinotecan directly through the hepatic artery as part of postoperative adjuvant treatment.

Study Details

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.

Key Dates

Start date
May 30, 2026
Status verified
Apr 2026
Primary completion
May 30, 2027
Completion
May 30, 2032

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine
    Participants will receive hepatic arterial infusion chemotherapy with liposomal irinotecan plus systemic chemotherapy with oxaliplatin and capecitabine. Each treatment cycle is 21 days. Treatment will be administered for 2 to 4 cycles. After 2 cycles, the investigator will decide whether to stop treatment or continue for another 2 cycles based on efficacy and tolerability.

Primary Outcome Measure

3-Year Disease-Free Survival Rate [ Time Frame: 3 years from initiation of study treatment. ]

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