A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

Exclusion Criteria22

• Mixed gastric or gastroesophageal Junction cancer containing other pathological components than adenocarcinoma
• HER2-positive
• Known other invasive malignancies within 3 years
• Subjects who are currently participating in other interventional study
• Received prior systemic anti-tumour therapy within 4 weeks before randomization
• Previous systemic treatment with taxane within 6 months before randomization
• Previous systemic treatment targeting VEGF or anti-VEGFR signaling pathways
• In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy or other therapy that targets anti-tumor immune mechanisms
• History of immune-related adverse effects leading to recommendation against reintroduction of immunotherapy or any condition dependency on systemic therapy with glucocorticoids or immunosuppressive agents within 14 days prior to randomization
• History of severe infection within 4 weeks prior to randomization
• Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
• History or presence of a serious hemorrhage or known bleeding tendency within 2 months before randomization
• Major surgical procedure or serious trauma within 28 days prior to randomization
• History of interstitial lung disease or noninfectious pneumonitis
• Active infectious diseases, including tuberculosis, HIV infection, syphilis infection，or hepatitis B/C
• Known allergy to the antibody or any component of the study drug; Or the constitution of being allergic to multiple substances
• History of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation
• Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
• Use of live vaccines within 30 days prior to randomization
• Pregnant or lactating women.
• Any condition considered by the investigator to be inappropriate for enrollment