78
Participants
Start Date
March 11, 2024
Primary Completion Date
January 1, 2026
Study Completion Date
May 1, 2026
Irinotecan Liposome
"In dose escalation study, irinotecan liposome injection will be administered by an intravenous infusion at three doses of 60 mg/m2, 70 mg/m2 and 80 mg/m2, d1, 14 days per cycle. In expansion study, irinotecan liposome injection will be administered by an intravenous infusion at the dose of RP2D, d1, 14 days per cycle.~Until the disease progresses or surgery is possible."
Oxaliplatin
85 mg/m2, intravenously infusion, d1, 14 days per cycle, up to 12 cycles.
5-FU
2400mg/m2, intravenous infusion, d1-2, 14 days per cycle. Until the disease progresses or surgery is possible.
LV
400mg/m2, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.
Bevacizumab
5mg/kg, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.It is used to patients in dose escalation phase and with gene mutation in extension phase.
Cetuximab
500mg/m2, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.For wild-type patients in extended phase studies.
RECRUITING
Zhongshan Hospital Affiliated to Fudan University, Shanghai
Collaborators (1)
CSPC Ouyi Pharmaceutical Co., Ltd.
INDUSTRY
Shanghai Zhongshan Hospital
OTHER