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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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
Oxaliplatin 130 mg/m2 i.v. on D1
Capecitabine 1000 mg/m2 p.o. Bid on Day 1-14
Bevacizumab 7.5 mg/kg i.v. on D1
The First Affiliated Hospital of Sun Yat-sen University,Lishui Central Hospital
Lishui, Zhejiang, China
RECRUITINGThe incidence of dose-limiting toxicity(DLT )
Time frame: The first Cycle(21 days)
Incidence and severity of AEs and SAEs (according to NCI-CTCAE 5.0)
Time frame: Up to approximately 1 years
AUC0-t
Time frame: The first four cycles ( each cycle is 21 days)
AUC0-∞
Time frame: The first four cycles ( each cycle is 21 days)
Cmax
Time frame: The first four cycles ( each cycle is 21 days)
Kel
Time frame: The first four cycles ( each cycle is 21 days)
Tmax
Time frame: The first four cycles ( each cycle is 21 days)
Vz
Time frame: The first four cycles ( each cycle is 21 days)
t1/2
Time frame: The first four cycles ( each cycle is 21 days)
CL
Time frame: The first four cycles ( each cycle is 21 days)
Overall response rate(ORR)
Time frame: Up to approximately 1 years
Disease control rate(DCR)
Time frame: Up to approximately 1 years
Duration of Response(DoR)
Time frame: Up to approximately 1 years
Progression-Free-Survival(PFS)
Time frame: Up to approximately 2 years
Time to Progression(TTP)
Time frame: Up to approximately 2 years
Overall survival(OS)
Time frame: Up to approximately 3 years
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