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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

February 16, 2023

Primary Completion Date

October 31, 2024

Study Completion Date

December 31, 2025

Conditions
Gastric Cancer Stage IV
Interventions
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.

Trial Locations (1)

350500

RECRUITING

Fujian cancer hospital, Fuzhou

All Listed Sponsors
lead

Fujian Cancer Hospital

OTHER_GOV