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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
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.
Frequently asked questions
Is NCT05476796 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Are patients with ERBB2 alterations eligible?
No. ERBB2 overexpression is an exclusion criterion.
Are patients with ERBB2 alterations eligible?
No. ERBB2 amplification is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify