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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Liver Metastasis; Colorectal Cancer Liver Metastases (CRLM)
• Intervention / Treatment: Drug: Liposomal Irinotecan; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: hepatic arterial infusion chemotherapy (HAIC)

Detailed Description

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
• Enrollment (Estimated): 28
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 to 75 years.
2. 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.
3. Histologically confirmed colorectal cancer liver metastases.
4. ECOG performance status of 0 or 1.
5. Expected survival of at least 3 months.
6. Clinical risk score of 3 or higher.
7. 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.
8. 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.
9. Adequate hepatic function, defined as serum bilirubin ≤1.5 × the upper limit of normal, transaminases ≤2.5 × the upper limit of normal or ≤5 × the upper limit of normal if liver metastasis is present, and alkaline phosphatase ≤5 × the upper limit of normal.
10. Female participants must not be pregnant or breastfeeding. Women of childbearing potential and male participants must use effective contraception during the study and for 6 months after completion of study treatment.
11. Good compliance, ability to understand the study procedures, and willingness to sign written informed consent.

Exclusion Criteria:

1. Contraindication to capecitabine, oxaliplatin, or irinotecan.
2. Any history of hepatic interventional therapy, including transarterial infusion, hepatic arterial infusion, or transarterial chemoembolization.
3. 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.
4. Dihydropyrimidine dehydrogenase deficiency.
5. History of severe cardiovascular disease resulting in inability to tolerate treatment.
6. Peripheral neuropathy greater than Grade 1.
7. History of another malignancy within the previous 5 years, except cured carcinoma in situ or basal cell carcinoma of the skin.
8. History of allogeneic organ transplantation.
9. Requirement for renal dialysis.
10. Breastfeeding, pregnancy, or inadequate contraception in women of childbearing potential.
11. Uncontrolled concomitant disease, including but not limited to severe active or uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, uncontrolled diabetes, or psychiatric illness that may affect study compliance.
12. Participation in another clinical trial currently or within 4 weeks before enrollment.
13. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years from initiation of study treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From the first dose of study treatment through the end-of-treatment visit and follow-up period, assessed for up to 3 years.

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2032

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Capecitabine; Hepatic arterial infusion chemotherapy; Colorectal cancer; Oxaliplatin; Disease-free survival; Liposomal irinotecan; Colorectal cancer liver metastases; No evidence of disease; Postoperative adjuvant therapy; Hepatic recurrence-free survival
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine; Oxaliplatin; irinotecan sucrosofate
• Other Study ID Numbers: CSPC-TJ-CRC-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in future publications will be shared, including demographic and baseline characteristics, surgical and disease status, treatment exposure, efficacy outcome data, safety data, recurrence data, survival data, and follow-up data. Data that could directly or indirectly identify participants, signed informed consent forms, raw source documents, and other confidential medical records will not be shared.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
• IPD Sharing Access Criteria: Data will be available to qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed and approved by the sponsor and principal investigators. Data will be shared after approval of the proposal and signing of a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No