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

NCT07570914 | Not Yet Recruiting Phase 2

• 1 other identifier: CSPC-TJ-CRC-05
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer Liver Metastases (CRLM); Colorectal Cancer; Liver Metastasis

Keywords

Colorectal cancer; Colorectal cancer liver metastases; Postoperative adjuvant therapy; Hepatic arterial infusion chemotherapy; Liposomal irinotecan; Oxaliplatin; Capecitabine; Disease-free survival; Hepatic recurrence-free survival; No evidence of disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival

  From enrollment to death from any cause, assessed for up to 3 years.

• Hepatic Recurrence-Free Survival

  From completion of study treatment to first hepatic recurrence, assessed for up to 3 years.

• Incidence and Severity of Adverse Events

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

Study Arms (1)

Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine

EXPERIMENTAL

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; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: hepatic arterial infusion chemotherapy (HAIC)

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.

Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine

Oxaliplatin DRUG

Oxaliplatin 100 mg/m\^2 will be administered by intravenous infusion on Day 1 of each 21-day cycle.

Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine

Capecitabine DRUG

Capecitabine 1000 mg/m\^2 will be administered orally twice daily on Days 1 to 14 of each 21-day cycle.

Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine

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.

Experimental: HAIC Liposomal Irinotecan Plus Oxaliplatin and Capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• Good compliance, ability to understand the study procedures, and willingness to sign written informed consent.

You may not qualify if:

• Contraindication to capecitabine, oxaliplatin, or irinotecan.
• 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.
• History of allogeneic organ transplantation.
• Requirement for renal dialysis.
• Breastfeeding, pregnancy, or inadequate contraception in women of childbearing potential.
• 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.
• Participation in another clinical trial currently or within 4 weeks before enrollment.
• Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

irinotecan sucrosofate; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2032
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
• 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.