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

Starting soon · Phase 3

Conditions studied: Gastric / Gastroesophageal Junction Adenocarcinoma

In brief

Key facts

Study ID: NCT07449780
Run by: Akeso
People needed: 422
Starts: 2026-03-31
Expected to finish: 2028-02-15
Last updated by the study team: 2026-03-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
Measurable disease by RECIST 1.1.

You may not qualify if…

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.
Prior treatment with immune checkpoint inhibitors.
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

Full record on ClinicalTrials.gov

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