Gastric / Gastroesophageal Junction AdenocarcinomaPhase 3NCT07449780
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 Phase 3 study testing AK104(SC), AK104(IV) and Capecitabine in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Akeso.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric / Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- AK104(SC), AK104(IV) and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 15 Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- AK104(SC), AK104(IV), Capecitabine, Oxaliplatin injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104(SC)Drug
AK104:subcutaneous injection
AK104(IV)Drug
AK104:intravenous
CapecitabineDrug
oral
Oxaliplatin injectionDrug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| AK104(SC)+XELOX | Experimental | AK104 SC plus XELOX Receives: Drug: AK104(SC); Drug: Capecitabine; Drug: Oxaliplatin injection |
| AK104(IV)+XELOX | Active comparator | AK104 IV plus XELOX Receives: Drug: AK104(IV); Drug: Capecitabine; Drug: Oxaliplatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).
Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2).
Measured: up to 4 weeks
Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.
Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration.
Measured: up to 4 weeks
Secondary outcomes (7)
Objective Response Rate (ORR) per RECIST 1.1
Assessed by investigators
Measured: up to 24 months
Disease Control Rate (DCR) per RECIST 1.1
Assessed by investigators
Measured: Up to 24 months
Progression-free survival (PFS) assessed by investigator per RECIST v1.1
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.
Measured: Up to 24 months
Duration of Response (DOR) assessed by investigator per RECIST v1.1
DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Measured: Up to 24 months
Time to Response (TTR) assessed by investigator per RECIST v1.1
TTR refers to Time to Response.
Measured: Up to 24 months
Overall Survival
OS is defined as the time from randomization to death due to any cause.
Measured: Up to 24 months
Number of participants with adverse event (AE)
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.
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion17 Nov 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric / Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanqiao Zhang, Principal investigator, The Second Affiliated Hospital of Harbin Medical UniversityTao Zhang, Principal investigator, UNIVERSITY OF SCIENCE AND TECHNOLOGY UNION HOSPITAL TONG JI MEDICAL COLLEGE HUA ZHONG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449780
- Sponsor's protocol ID
- AK104-SC-01
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07449780
- Acronym / sponsor ID
- AK104-SC-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 17 Nov 2027 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK104(SC)+XELOX | Experimental | Drug: AK104(SC), Drug: Capecitabine, Drug: Oxaliplatin injectionAK104 SC plus XELOX |
| AK104(IV)+XELOX | Active comparator | Drug: AK104(IV), Drug: Capecitabine, Drug: Oxaliplatin injectionAK104 IV plus XELOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104(SC)AK104:subcutaneous injection | Drug | AK104(SC)+XELOX |
| AK104(IV)AK104:intravenous | Drug | AK104(IV)+XELOX |
| Capecitabineoral | Drug | AK104(IV)+XELOX, AK104(SC)+XELOX |
| Oxaliplatin injectionintravenous | Drug | AK104(IV)+XELOX, AK104(SC)+XELOX |
Primary outcome
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).
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.
7 secondary outcomes
Objective Response Rate (ORR) per RECIST 1.1
Time frame: up to 24 months
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Up to 24 months
Progression-free survival (PFS) assessed by investigator per RECIST v1.1
Time frame: Up to 24 months
Duration of Response (DOR) assessed by investigator per RECIST v1.1
Time frame: Up to 24 months
Time to Response (TTR) assessed by investigator per RECIST v1.1
Time frame: Up to 24 months
Overall Survival
Time frame: Up to 24 months
Number of participants with adverse event (AE)
Time frame: Up to 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanqiao Zhang principal investigator
The Second Affiliated Hospital of Harbin Medical University
Tao Zhang principal investigator
UNIVERSITY OF SCIENCE AND TECHNOLOGY UNION HOSPITAL TONG JI MEDICAL COLLEGE HUA ZHONG
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK104(SC), AK104(IV) and Capecitabine in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Akeso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Liu (+86 (0760) 8987 3999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.