NCT07117435

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes 2 parts. In Phase Ib part of this study, paclitaxel cationic liposome was administered via hepatic arterial infusion on Day 15 of each 3-week cycle, and in a gradual increment dose from the low-level to the high-level, with the first cycle (21 days) being the DLT observation period. In the Phase III part of this study, participants will be randomized in 1:1 ratio to receive either hepatic arterial infusion of paclitaxel cationic liposome (at the dose to be determined in the Phase Ib) in combination with systemic therapy or systemic therapy. The primary purpose of the Phase Ib part of this study is to determine the recommended Phase III dose (RP3D) of paclitaxel cationic liposome administered via hepatic arterial infusion on Day 15 of each 3-week cycle. The primary purpose of the Phase III part of this study is to measure 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

Type	Name	Description
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

Timeline

• Start date: 2025-05-13
• Primary completion: 2025-12-30
• Completion: 2026-06-01
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: China