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

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT07117435
Phase
PHASE1
Status
Recruiting
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Conditions

  • Colorectal Liver Metastases
  • First-line Treatment

Eligibility Criteria

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

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
  • Oxaliplatin — DRUG
    Oxaliplatin 130 mg/m2 i.v. on D1
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m2 p.o. Bid on Day 1-14
  • Bevacizumab — DRUG
    Bevacizumab 7.5 mg/kg i.v. on D1

Study Details

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.

Key Dates

First listed
Aug 12, 2025
Start date
May 13, 2025
Status verified
Aug 2025
Primary completion
Dec 30, 2025
Completion
Jun 1, 2026

Study Design

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

Arms

  • Experimental: Experimental arm
    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)

Primary Outcome Measure

The incidence of dose-limiting toxicity（DLT ） [ Time Frame: The first Cycle(21 days) ]

Central Contacts

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