The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
Fujian cancer hospital
Fuzhou, Fujian, China
RECRUITINGThe maximum dose tolerated
To determine the maximum tolerated dose of POFI with different doses of irinotecan and paclitaxel combined with Tislelizumab in the first month.
Time frame: 1 month
Overall Response Rate
Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
Time frame: 2 years
Progression-free survival
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
Time frame: 2 years
Overall survival
The length of time from enrollment until the time of death (OS, overall survival).
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Paclitaxel will be administered on day 1 of each cycle at 45mg/m2 at dose level 1; 67.5 mg/m2 at dose level 2 ; 90 mg/m2 at dose level 3; 112.5 mg/m2 at dose level 4 once every 14 days.
Irinotecan will be administered on day 1 of each cycle at 135 mg/m2 at dose level 1; 150 mg/m2 at dose level 2 once every 14 days.
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.