Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant T… (NCT07570914) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases
28 participantsStarted 2026-05-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18 to 75 years.
✓. Completion of radical resection of the colorectal primary tumor and liver metastases within 12 weeks before enrollment, with postoperative imaging showing no residual lesion, recurrence, or extrahepatic metastasis, indicating no evidence of disease.
✓. Histologically confirmed colorectal cancer liver metastases.
✓. ECOG performance status of 0 or 1.
✓. Expected survival of at least 3 months.
✓. Clinical risk score of 3 or higher.
✓. Adequate bone marrow function, defined as absolute neutrophil count \>2 × 10\^9/L, hemoglobin \>9.0 g/dL, and platelet count \>100 × 10\^9/L.
✓. Adequate renal function, defined as serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥30 mL/min according to the Cockcroft-Gault formula.
Exclusion criteria
✕. Contraindication to capecitabine, oxaliplatin, or irinotecan.
What they're measuring
1
3-Year Disease-Free Survival Rate
Timeframe: 3 years from initiation of study treatment.
Trial details
NCT IDNCT07570914
SponsorTianjin Medical University Cancer Institute and Hospital
✕. Any history of hepatic interventional therapy, including transarterial infusion, hepatic arterial infusion, or transarterial chemoembolization.
✕. Receipt of adjuvant chemotherapy containing irinotecan after resection of the primary tumor, or receipt of adjuvant therapy without irinotecan with the last dose administered within 3 months before enrollment.
✕. Dihydropyrimidine dehydrogenase deficiency.
✕. History of severe cardiovascular disease resulting in inability to tolerate treatment.
✕. Peripheral neuropathy greater than Grade 1.
✕. History of another malignancy within the previous 5 years, except cured carcinoma in situ or basal cell carcinoma of the skin.