NCT05319639

Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab

Phase I/II Study of the Combination of Irinotecan and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) and Tislelizumab

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
DRUG	Levo-Leucovorin	Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
DRUG	5-fluorouracil	5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
DRUG	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.
DRUG	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.
DRUG	Tislelizumab	Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Timeline

• Start date: 2023-02-16
• Primary completion: 2024-10-31
• Completion: 2025-12-31
• First posted: 2022-04-08
• Last updated: 2025-02-27

Locations

1 site across 1 country: China