Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07449780

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 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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Gastric / Gastroesophageal Junction Adenocarcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

AK104(SC)

Drug

AK104:subcutaneous injection

AK104(IV)

Drug

AK104:intravenous

Capecitabine

Drug

oral

Oxaliplatin injection

Drug

intravenous

Primary outcomes

  1. Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).

    Time frame: up to 4 weeks

    Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).

  2. Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.

    Time frame: up to 4 weeks

    Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.

Secondary outcomes

  1. Objective Response Rate (ORR) per RECIST 1.1

    Time frame: up to 24 months

    Assessed by investigators

  2. Disease Control Rate (DCR) per RECIST 1.1

    Time frame: Up to 24 months

    Assessed by investigators

  3. Progression-free survival (PFS) assessed by investigator per RECIST v1.1

    Time frame: Up to 24 months

    PFS is defined as the time from randomization till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first.

  4. Duration of Response (DOR) assessed by investigator per RECIST v1.1

    Time frame: Up to 24 months

    DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

  5. Time to Response (TTR) assessed by investigator per RECIST v1.1

    Time frame: Up to 24 months

    TTR refers to Time to Response.

  6. Overall Survival

    Time frame: Up to 24 months

    OS is defined as the time from randomization to death due to any cause.

  7. Number of participants with adverse event (AE)

    Time frame: Up to 27 months

    The number of participants experiencing an Adverse Event (AE) and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Liu

CONTACT

[email protected]

+86 (0760) 8987 3999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.