Immunotherapy plus chemo aims to shrink stomach tumors before surgery
NCT ID NCT07522151
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Gastric cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGBeijing, Beijing Municipality, 10000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a personalized menu keep cancer patients stronger through chemotherapy?
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors