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

NCT07117435 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-08-12

No results posted yet for this study

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

Interventions

DRUG

paclitaxel cationic liposome for injection

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

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 i.v. on D1

DRUG

Capecitabine

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

DRUG

Bevacizumab

Bevacizumab 7.5 mg/kg i.v. on D1

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2025-12-30
Completion
2026-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07117435 on ClinicalTrials.gov