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Immunotherapy plus chemo aims to shrink stomach tumors before surgery

NCT ID NCT07522151

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding the immunotherapy drug adebrelimab to standard chemotherapy (S-1 and oxaliplatin) works better than chemo alone for people with stomach or gastroesophageal junction cancer that can be surgically removed. About 874 participants will receive the treatment or a placebo before and after surgery. The study measures how long patients live without cancer returning and how well the tumor responds to treatment.

What this could mean

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

Active substance
Adebrelimab (an immunotherapy drug) plus S-1 and oxaliplatin (chemotherapy)
What this could lead to
If successful, this combination could become a new standard treatment to reduce cancer recurrence and improve survival for people with resectable gastric cancer.
What could go wrong
This is a large phase 3 trial, but immunotherapy can cause immune-related side effects. The benefit over standard chemo alone is not yet proven, and results may not apply to all patients.

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 874 people

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

Started

May 2026

Expected to finish

Feb 2034

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. Patients with pathologically confirmed gastric cancer or gastroesophageal junction cancer. 2. Age: ≥18 years old, \<75 years old, both male and female are eligible. 3. Before entering the study, the investigator has evaluated and determined that the subject is suitable and plans to undergo neoadjuvant therapy + radical surgery for curative purposes. 4. Gastric cancer or gastroesophageal junction cancer applicable to the 8th edition of the AJCC gastric cancer staging criteria. 5. Fresh specimens (preferred) or formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections obtained within 6 months before randomization can be provided. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1. 7. Expected survival ≥ 6 months. 8. Adequate organ and bone marrow function. 9. Female subjects are either infertile or fertile, with a negative serum pregnancy test result within 3 days before the start of study medication and not in the lactation period. Fertile female subjects and male subjects whose partners are fertile must agree to avoid sperm/egg donation from the time of signing the informed consent form until 6 months after the last administration of the investigational drug, and comply with relevant contraceptive requirements. 10. Consent has been obtained from the individual and the informed consent form has been signed, willing and able to comply with planned visits, study treatment, laboratory tests, and other trial procedures. Exclusion Criteria: 1. Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other histological types, or adenocarcinoma mixed with other histological types. 2. Gastric esophageal junction cancer, Siewert type I; or Siewert type II with esophageal invasion length ≥ 4 cm; or other cases not suitable for clinical staging assessment using the 8th edition of the AJCC gastric cancer staging criteria, or not suitable for conventional surgical methods or approaches for gastric cancer. 3. The subject's weight has decreased by more than 20% within 2 months before randomization. 4. Previous anti-tumor treatment for gastric cancer/gastric esophageal junction cancer (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization). 5. Known allergy to any component of the investigational drug (including adibelimab/placebo, tegafur, and oxaliplatin), or allergy to humanized monoclonal antibody products. 6. Diagnosis of any other malignant tumor within 5 years before entering the study, except for locally treatable and cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma. 7. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or organ transplantation (including allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, etc.); history of active autoimmune disease, except for immune disorders that do not require systemic treatment (such as vitiligo, psoriasis, etc.) or autoimmune diseases that can be improved through hormone replacement therapy (such as type 1 diabetes or hypothyroidism). 8. Severe, unhealed or open wounds, active ulcers, or untreated fractures. 9. Active severe digestive system diseases. 10. Presence of interstitial pneumonia or interstitial lung disease. 11. Severe cardiovascular or metabolic diseases. 12. Active HBV or HCV infection (HBsAg positive and viral copy number ≥ 2000 IU/mL, HCV antibody positive and HCV RNA above the upper limit of normal at the research center), or co-infection with hepatitis B and hepatitis C. 13. Active tuberculosis infection within 1 year before randomization (including but not limited to pulmonary tuberculosis, intestinal tuberculosis, etc.), or a history of active tuberculosis infection more than 1 year ago but without regular treatment. 14. Severe infection within 4 weeks before randomization. 15. Known history of abuse of psychotropic drugs or drug addiction. 16. Presence of other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participation in the study, or interfere with the study results, and patients considered unsuitable for participation in the study by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  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

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 10000, China

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Other studies related to the condition(s) this trial covers.