Can immunotherapy outperform chemo after stomach cancer surgery?
NCT ID NCT05468138
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial is testing whether giving a PD-1 immunotherapy drug after surgery can help people with a specific type of stomach cancer (MSI-H) live longer without the cancer coming back. Participants who had surgery to remove their stomach cancer will be randomly assigned to receive either standard chemotherapy, the immunotherapy drug, or just follow-up observation. The goal is to see if immunotherapy offers a better chance of staying cancer-free for three years compared to the other options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1 monoclonal antibody immunotherapy (compared to standard chemotherapy or observation)
- What this could lead to
- If successful, this could establish immunotherapy as a better post-surgery option for MSI-H gastric cancer patients, potentially improving survival and reducing recurrence.
- What could go wrong
- This is a small phase II trial, so results may not be conclusive. Immunotherapy can cause immune-related side effects, and it's unclear if it will outperform standard chemo or observation in this setting.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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. Written (signed) informed consent; 2. D2 radical gastrectomy for gastric cancer 3. Postoperative pathology confirmed II-IIIc stage gastric adenocarcinoma with dMMR/MSI-H status; 4. Female or male, 18-75 years; 5. ECOG 0-1, no surgery contraindications; 6. No initial treatment (radiotherapy / chemotherapy / immunotherapy).; 7. Esophagus not involved ≥ 3cm; 8. Basic diseases without thyroid and cardiopulmonary dysfunction 9. Adequate hematological, liver, renal and coagulation function; 1) Platelet (PLT) count ≥100,000 /mm3; 2) Neutrophil count (ANC) ≥1,500 /mm3; 3) Hemoglobin (Hb) level ≥9.0 g/dl; 4) International normalized ratio (INR) ≤1.5; 5) Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN; 6) Glycosylated hemoglobin (HbA1c) \<7.5%; 7) Total bilirubin (TBIL) level ≤1.5×ULN; 8) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 9) Alkaline phosphatase level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 10) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance ≥60 ml/min; 11) Thyroid stimulating hormone (TSH) ≤ULN; 12) Normal serum free thyroid hormone (T4); 13) Normal serum free triiodothyronine (T3); 14) Serum amylase ≤1.5×ULN; 15) Lipase ≤1.5×ULN. 10. Females of child bearing age must have a negative pregnancy test, and have to take contraception measures and avoid breast feeding during the study and for 3 months after the last dose; male subjects must agree to taken contraception measures during the study and for 3 months after the last dose. Exclusion Criteria: 1. Known allergy to study drug or excipients, or allergy to similar drugs; 2. Patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured localized tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ; 3. Uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment; 4. The patient has a serious history of heart disease, including congestive heart failure, uncontrollable arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease and intractable hypertension; 5. Unable to swallow study drug; 6. Prior chemotherapy, radiotherapy for gastric cancer; 7. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent; 8. Prior therapy with tyrosine kinase inhibitor within 2 weeks. 9. Concurrent medical condition requiring the use of cortisol (\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent for replacement therapy; 10. Have vaccination with attenuated live vaccines within 4 weeks prior to initiation of the study treatment or plan to vaccinate during the study; 11. Poorly controlled hypertension or diabetes; 12. With bleeding tendency, or evident hemoptysis or other hemorrhagic events (e.g. gastrointestinal hemorrhage, hemorrhagic gastric ulcer) within 2 months prior to initiation of study treatment, or presence of hereditary or acquired bleeding or thrombotic tendency (e.g. hemophilia, coagulopathy, thrombocytopenia, etc.), or current/long-term thrombolytic or anticoagulant therapy (except aspirin ≤100 mg/day); 13. Present or history of any autoimmune disease; 14. With active tuberculosis or receiving previous anti-tuberculosis therapy within one year; 15. Diagnosed with interstitial pneumonia, non-infectious pneumonia, pulmonary fibrosis, acute lung disease; 16. Pregnancy or breast feeding; 17. Human immunodeficiency virus (HIV) infection (HIV antibody positive), or active hepatitis C virus (HCV) infection (HCV antibody positive), or active hepatitis B virus (HBV) infection (HBsAg or HBcAb positive, and HBV-DNA ≥2000 IU/ml (copies/ml)), or other severe infection requiring systemic antibiotic treatment, or unexplained body temperature \>38.5℃ during screening period/before study treatment; 18. Patients with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.
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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.
Contacts and locations
Locations
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Dazhi Xu
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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