A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Eligibility criteria

Qualifiers

Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).

Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).

Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Adequate organ and bone marrow function.

Disqualifiers

Receipt of systemic non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymic peptides, etc.) within 2 weeks prior to the first dose.Receipt of Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose.

Deep venous thrombosis within 3 months before first treatment.

Uncontrolled arterial hypertension.

Bleeding events within the last 1 months.

Trial design

Treatments tested in this trial

  • AK104(SC)
  • AK104(IV)
  • Capecitabine
  • Oxaliplatin injection

Treatment groups

422 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators