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.
Histologically confirmed locally advanced, recurrent or metastatic non resectable adenocarcinoma of the stomach, oesophagus or gastroesophageal junction (GEJ) ineligible to curative treatment.
No dysphagia or difficulty in swallowing.
No overexpression/amplification of HER2 (IHC 0 or 1+; if IHC is 2+, HIS must be negative). Known combined positive scor (CPS) PD-L1 score (result in % with the name of the method used). The microsatellite and mismatch repair (MMR) status of patient's tumour (MSI/MSS and pMMR/dMMR) must also be known at the time of screening (IHC and PCR tests have to be done).
At least one evaluable lesion according to RECIST v1.1 outside any previously irradiated area.
Patient with a performance status ECOG PS >2.
Other current or previous malignancy within the past 3 years (with the exception of squamous cell carcinoma of the skin treated by surgery).
Adjuvant chemotherapy or radio-chemotherapy completed for less than 6 months.
Peripheral neuropathy of NCI-CTCAE grade ≥2 at baseline.
UNICANCER
Lead sponsor
Servier
Collaborator