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RECRUITING
NCT07117435
PHASE1

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.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2025-05-13

Completion Date

2026-06-01

Last Updated

2025-08-12

Healthy Volunteers

No

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

Locations (1)

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

Lishui, Zhejiang, China