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RECRUITING
NCT05319639
PHASE1/PHASE2

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

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

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

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.

Locations (1)

Fujian cancer hospital

Fuzhou, Fujian, China