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OncoMatch/Clinical Trials/NCT05319639

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

Is NCT05319639 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for gastric cancer stage iv.

Phase 1/2RecruitingFujian Cancer HospitalNCT05319639Data as of Jun 2026Location: China

Treatment: Oxaliplatin · Levo-Leucovorin · 5-fluorouracil · Paclitaxel · Irinotecan · TislelizumabThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Tislelizumab

Chemotherapy

Oxaliplatin5-fluorouracilPaclitaxelIrinotecan

Other

Levo-Leucovorin

Cancer type

Gastric Cancer

Disease stage

Required: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT05319639 currently recruiting?

Yes, this trial is currently recruiting patients.

What disease stage is eligible?

Stage IV is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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