PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer

Korábbi kezelés

• Previous use of non-surgical therapy (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric adenocarcinoma.
• Previous history of serious allergy to monoclonal antibody or other biological preparations.

Más betegség

• Having malignant tumors other than gastric adenocarcinoma within 5 years before randomization.

Laborértékek

• Pevious treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) receptor;

Egyéb

• Having liver, peritoneal or other distant metastasis.

• Age 18-75 years.
• No residual tumor (R0) after D2 or greater lymphadenectomy through laparotomy.
• According to the definition of the 8th edition of the AJCC Cancer Staging Manual, patients with gastric adenocarcinoma confirmed by histopathology, pathological stage II (T4aN0M0) and stage III, including gastroesophageal junction adenocarcinoma (GEJ) patients.
• Patients need to provide sufficient formalin-fixed paraffin-embedded (FFPE) neoplasm tissue specimens or sections that are confirmed to be PD-L1 positive (CPS ≥ 1) by lab test at the central laboratory.
• ECOG performance status 0-1.
• No metastasis or recurrence as radiologically confirmed.
• Patients must have adequate organ function as assessed in the laboratory tests.
• Patients must provide informed consent for this study, and sign the written informed consent form voluntarily before the initiation of the study, and are willing and able to comply with the scheduled visits, treatment plan, laboratory examinations and other study procedures in the study.
• Female patients of childbearing age must take a serum pregnancy test within 7 days before randomization with negative results, and agree to adopt reliable and effective contraceptive methods during the study.