OncoMatch/Clinical Trials/NCT05319639
Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab
Is NCT05319639 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for gastric cancer stage iv.
Treatment: Oxaliplatin · Levo-Leucovorin · 5-fluorouracil · Paclitaxel · Irinotecan · Tislelizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); leucopenia count of ≥4.0×10^9/L; platelet count of ≥100×10^9/L
Kidney function
creatinine (Cr) of ≤ 1.5 UNL; creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault)
Liver function
total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis
Cardiac function
normal electrocardiogram results and no history of congestive heart failure
With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis. With normal electrocardiogram results and no history of congestive heart failure.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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