NCT07449780Not yet recruitingPhase 3
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
A Randomized, Open-Label, Multicenter, Phase I/III Clinical Study to Evaluate the Pharmacokinetics, Efficacy and Safety of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Regimen Versus AK104 (IV) in Combination With XELOX Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 422 (estimated)
- First submitted
- 27 Feb 2026
- Start date
- 31 Mar 2026
- Primary completion date
- 17 Nov 2027
- Lead sponsor
- Akeso
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07449780
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 422
- From 31 Mar 2026 to the primary completion date, 17 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior treatment with immune checkpoint inhibitors.
Other illness
- Uncontrolled arterial hypertension.
- Bleeding events within the last 1 months.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.