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Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab
Sponsor: Fujian Cancer Hospital
Summary
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.
Official title: Phase I/II Study of the Combination of Irinotecan and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) and Tislelizumab
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2023-02-16
Completion Date
2025-12-31
Last Updated
2025-02-27
Healthy Volunteers
No
Conditions
Interventions
Oxaliplatin
Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
Levo-Leucovorin
Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
5-fluorouracil
5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
Paclitaxel
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
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
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
Locations (1)
Fujian cancer hospital
Fuzhou, Fujian, China