OncoMatch/Clinical Trials/NCT06793917
Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced: a Multicenter, Open-label, Randomized Phase III Studyunresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
Is NCT06793917 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for gastric cancer.
Treatment: Tislelizumab · Oxaliplatin · Levo-Leucovorin · 5-fluorouracil · Paclitaxel — To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: PD-L1 (CD274) CPS testing required (testing required; no eligibility threshold specified)
Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing
Required: MMR testing required (testing required; no eligibility threshold specified)
Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing
Required: MSH2 testing required (testing required; no eligibility threshold specified)
Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing
Required: HER2 (ERBB2) testing required (testing required; no eligibility threshold specified)
Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing
Excluded: HER2 (ERBB2) overexpression
Her2-positive (IHC 3+ or 2+/FISH+) patients
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included
No previous chemotherapy (perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included)
Cannot have received: radiotherapy
No previous...radiotherapy
Cannot have received: immunotherapy
No previous...immunotherapy
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 ≥4.0×10^9/L; a platelet count of ≥100×10^9/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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