Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT07117435
Brief 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.
Study:
NCT07117435
Study Brief:
Protocol Section:
NCT07117435