Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases

NCT07117435 | Recruiting Phase 1

• 1 other identifier: HA131-004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ib/III, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.

Conditions

Colorectal Liver Metastases; First-line Treatment

Outcome Measures

Primary Outcomes (2)

• The incidence of dose-limiting toxicity（DLT ）

  The first Cycle(21 days)

• Incidence and severity of AEs and SAEs (according to NCI-CTCAE 5.0)

  Up to approximately 1 years

Secondary Outcomes (14)

• AUC0-t

  The first four cycles ( each cycle is 21 days)

• AUC0-∞

  The first four cycles ( each cycle is 21 days)

• Cmax

  The first four cycles ( each cycle is 21 days)

• Kel

  The first four cycles ( each cycle is 21 days)

• Tmax

  The first four cycles ( each cycle is 21 days)

Study Arms (1)

Experimental arm

EXPERIMENTAL

Paclitaxel cationic liposome was administered via hepatic arterial infusion on Day 15 of each 3-week cycle, and in a gradual increment dose range from 33 mg/m\^2 to 55 mg/m\^2, combined with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab)

Drug: paclitaxel cationic liposome for injection; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab

Interventions

paclitaxel cationic liposome for injection DRUG

Paclitaxel cationic liposome was administered through hepatic arterial catheter infusion, in a gradual increment dose range from 33 mg/m\^2 to 55 mg/m\^2

Experimental arm

Oxaliplatin DRUG

Oxaliplatin 130 mg/m2 i.v. on D1

Experimental arm

Capecitabine DRUG

Capecitabine 1000 mg/m2 p.o. Bid on Day 1-14

Experimental arm

Bevacizumab DRUG

Bevacizumab 7.5 mg/kg i.v. on D1

Experimental arm

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 range: 18 - 75 years old (inclusive), gender not limited.
• \. For patients with colorectal liver metastases have been histologically or cytologically confirmed and who are assessed by multidisciplinary team (MDT) to be inoperable for radical surgical resection:
• Have not received systemic treatment for the metastatic or recurrent disease;
• For patients who have received neoadjuvant/adjuvant therapy before, the time interval between the last administration and disease progression must be ≥ 6 months;
• Allow patients who have received local treatment and progressed.
• \. According to RECIST v1.1, at least one measurable lesion in the hepatic arterial infusion area (long diameter ≥ 1 cm and no previous local treatment).
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• \. Life expectancy of at least 3 months.
• \. Adequate organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factors within 14 days)
• \. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the study and for at least 6 months after the last dose of study intervention. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
• \. Fully understand the clinical study and voluntarily sign a written informed consent form.

You may not qualify if:

• \. Patients known to have microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR), and have been evaluated by the investigators to be eligible for immune checkpoint inhibitor therapy.
• \. Patients known to have wild-type RAS and BRAF, and have been evaluated by the investigators to be eligible for anti-epidermal growth factor receptor (EGFR) drug therapy.
• \. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigators).
• \. Central nervous system metastasis with clinical symptoms, or meningeal metastasis, or there are other evidences indicating that the patient's central nervous system metastasis or meningeal metastatic lesions have not been controlled, and the investigators judges that the patient is not suitable for enrollment.
• \. Patients with contraindications for transcatheter arterial infusion.
• \. Patients with active infections within 2 weeks prior to administration (NCI CTC AE v5.0 ≥ grade 2) (Defined as requiring intravenous administration of antibacterial, antifungal or antiviral drugs for treatment).
• \. Patients with grade 2 or above peripheral neuropathy (NCI CTC AE v5.0).
• \. Patients with a history of autoimmune diseases, immunodeficiency disorders, including HIV positive test results, or suffering from other acquired or congenital immune deficiencies, or those currently using immunosuppressive agents.
• \. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with HBV DNA ≥ 2×103 IU/mL (can use continuous antiviral treatment); or anti-hepatitis C virus antibody (HCV-Ab) positive with HCV RNA above the measurable limit; or active syphilis.
• \. Patients with known contraindications to capecitabine or oxaliplatin, paclitaxel or cationic liposome, or have severe allergic reactions; note: If the subject has contraindications to bevacizumab or has severe allergic reactions to any component of bevacizumab, it will not affect the enrollment but should not use bevacizumab in the study, and the specific reasons need to be recorded.
• \. Patients need to receive strong inducers and strong inhibitors of CYP2C8 and CYP3A4 within 2 weeks before the first study treatment or during the treatment.
• \. Patients had or have non-infectious pneumonia/interstitial lung disease that requires systemic glucocorticoid treatment.
• \. Severe cardiovascular disease history, including but not limited to:
• Long QT syndrome;
• High-degree atrioventricular block;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University，Lishui Central Hospital

Lishui, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Injections; Oxaliplatin; Capecitabine; Bevacizumab

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; 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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants receive the same treatment, and there is no comparison group.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: May 13, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

CN (1)