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Shot vs. IV: could a simple injection improve stomach cancer treatment?

NCT ID NCT07449780

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways of giving the immunotherapy drug AK104 alongside standard chemotherapy for people with advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery. One group gets AK104 as a shot under the skin (subcutaneous), the other as an IV infusion. The goal is to see if the shot works as well and is safer. About 422 participants will take part, and the study has not started recruiting yet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AK104 (a type of immunotherapy) plus oxaliplatin and capecitabine chemotherapy
What this could lead to
If successful, this could offer a more convenient subcutaneous injection option for immunotherapy in advanced gastric cancer, potentially improving quality of life.
What could go wrong
This is an early-stage comparison of two delivery methods; it may not show a clear benefit in survival or tumor shrinkage. Side effects from immunotherapy and chemotherapy can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 422 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). 2. Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ). 3. Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. 4. Adequate organ and bone marrow function. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 6. Measurable disease by RECIST 1.1. Exclusion Criteria: 1. 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. 2. Deep venous thrombosis within 3 months before first treatment. 3. Uncontrolled arterial hypertension. 4. Bleeding events within the last 1 months. 5. Prior treatment with immune checkpoint inhibitors. 6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric/gastroesophageal junction adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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