OncoMatch/Clinical Trials/NCT05476796
Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer
Is NCT05476796 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trifluridine/Tipiracil and Oxaliplatin for gastric adenocarcinoma.
Treatment: Trifluridine/Tipiracil · Oxaliplatin · FOLFOX regimen · Nivolumab — Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (CPS PD-L1 score (result in % with the name of the method used))
Known combined positive scor (CPS) PD-L1 score (result in % with the name of the method used)
Excluded: HER2 (ERBB2) overexpression
No overexpression/amplification of HER2 (IHC 0 or 1+; if IHC is 2+, HIS must be negative)
Excluded: HER2 (ERBB2) amplification
No overexpression/amplification of HER2 (IHC 0 or 1+; if IHC is 2+, HIS must be negative)
Excluded: DPYD deficiency
No Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia <16 ng/ml)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: palliative chemotherapy
No prior palliative chemotherapy
Cannot have received: trifluridine/tipiracil (trifluridine/tipiracil)
Previous treatment with trifluridine/tipiracil
Cannot have received: adjuvant chemotherapy or radio-chemotherapy
Exception: completed for less than 6 months
Adjuvant chemotherapy or radio-chemotherapy completed for less than 6 months
Lab requirements
Blood counts
Absolute neutrophils count ≥1.5x10⁹/L; Platelets count ≥100x10⁹/L; Haemoglobin ≥9 g/L
Kidney function
Creatinine clearance >40 mL/min
Liver function
Serum bilirubin levels <2 times ULN, up to 2.5 times ULN in case of hepatic metastasis (biliary drainage allowed); Transaminases <5 times ULN
Cardiac function
Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec) [excluded]
Adequate organs function: Absolute neutrophils count ≥1.5x10⁹/L; Platelets count ≥100x10⁹/L; Haemoglobin ≥9 g/L; Serum bilirubin levels <2 times ULN, up to 2.5 times ULN in case of hepatic metastasis (biliary drainage allowed); Transaminases <5 times ULN; Creatinine clearance >40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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