RecruitingPhase 1NCT07117435

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

A Phase Ib/III Study to Evaluate the Safety and Efficacy of 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.

Enrollment

7 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab, a drug called Capecitabine, and others for people with colorectal liver metastases and first-line treatment. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpaclitaxel 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

DRUGOxaliplatin

Oxaliplatin 130 mg/m2 i.v. on D1

DRUGCapecitabine

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

DRUGBevacizumab

Bevacizumab 7.5 mg/kg i.v. on D1


Locations(1)

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

Lishui, Zhejiang, China

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NCT07117435


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