Can adding immunotherapy to chemotherapy keep stomach cancer at bay?
NCT ID NCT07772557
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial is testing whether adding the immunotherapy drug serplulimab to a standard chemotherapy regimen (SOX) after surgery can help prevent stomach or gastroesophageal junction cancer from coming back. The study includes adults with stage II-III cancer whose tumors show certain markers (PD-L1 CPS ≥5, EBV-positive, or dMMR/MSI-H) that may make them more responsive to immunotherapy. Participants are randomly assigned to receive either the combination or chemotherapy alone, and the main goal is to compare the proportion of patients who remain cancer-free three years after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- serplulimab combined with a chemotherapy regimen (oxaliplatin and S-1)
- What this could lead to
- If successful, this could establish a new adjuvant therapy that lowers the chance of gastric cancer returning after surgery.
- What could go wrong
- This is a phase 2 trial with a relatively small number of participants, so results may not be definitive. Immunotherapy can cause immune-related side effects, and the benefit 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
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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 108 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2032
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: * The patient voluntarily joins this study and signs the informed consent form. * Age ≥18 years and ≤75 years, male or female. * Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (predominantly adenocarcinoma) with stage II-III disease (TNM staging, 8th UICC/AJCC) who have not received preoperative neoadjuvant therapy. * ECOG performance status: 0-1. * Postoperative testing of gastric cancer specimens indicates: PD-L1 CPS ≥5, or EBV-positive, or dMMR. * No prior anti-tumor therapy for gastric cancer, including chemotherapy, targeted therapy, immunotherapy, or local radiotherapy. * Female patients of childbearing potential (not surgically sterilized) must use a medically acceptable contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the end of the study treatment. Female patients of childbearing potential must have a negative serum or urine HCG test within 72 hours prior to study enrollment and must not be breastfeeding. Male patients must be surgically sterilized or agree to use an appropriate contraceptive method during the study period and for 3 months after the last dose of the investigational drug. * Baseline hematological and biochemical parameters must meet the following criteria: Hemoglobin ≥90 g/L; Absolute neutrophil count ≥1.5×10⁹/L; Platelet count ≥100×10⁹/L; Hepatic function: ALT ≤2.5×ULN, AST ≤2.5×ULN, TBIL ≤1.5×ULN (for patients with liver metastases: ALT ≤5×ULN, AST ≤5×ULN, TBIL ≤3×ULN); Renal function: Creatinine ≤1.5×ULN, or when creatinine \>1.5×ULN, endogenous creatinine clearance \>50 mL/min; Alkaline phosphatase ≤2.5×ULN; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, T3 and T4 levels should be evaluated; patients may be enrolled if T3 and T4 levels are within normal limits). Exclusion Criteria: * The patient voluntarily joins this study and signs the informed consent form. (Note: This item appears to be an inclusion criterion and is likely misplaced. Please verify.) * Pregnant or breastfeeding women. * Women of childbearing potential with a positive baseline pregnancy test. * Distant metastasis diagnosed by CT/MRI/EUS. * Prior anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy. * Diagnosis of another malignancy within the past 5 years (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer). * Uncontrolled pleural effusion, pericardial effusion, or ascites. * Severe cardiovascular disease within 12 months prior to enrollment, such as symptomatic coronary artery disease, congestive heart failure ≥ Class II, uncontrolled arrhythmia, or myocardial infarction. * Concurrent upper gastrointestinal obstruction/bleeding, or digestive dysfunction/malabsorption syndrome that may affect the absorption of S-1. * Concurrent severe uncontrolled infection or other severe uncontrolled concomitant disease, moderate or severe renal impairment. * History of allergic reactions to any of the study drugs. * Use of corticosteroids or other systemic immunosuppressive therapy within 14 days prior to enrollment. * Receipt of an investigational drug within 4 weeks prior to enrollment (participation in another clinical trial). * Active autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator therapy). Subjects with hypothyroidism requiring only hormone replacement therapy, or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), may be enrolled. * History of primary immunodeficiency. * Use of immunosuppressive agents within 4 weeks prior to the first dose of study treatment, excluding nasal sprays, inhaled, or other topical corticosteroids, or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/day of prednisone or equivalent), or prophylactic use of corticosteroids for contrast allergy. * Receipt of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment, or planned receipt during the study period. * Known interstitial pneumonia or active pulmonary tuberculosis. * History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Positive HIV antibody, active hepatitis B or hepatitis C (hepatitis B: HBsAg positive and HBV-DNA ≥10⁴ copies/mL; hepatitis C: HCV antibody and HCV-RNA positive, requiring concurrent antiviral therapy). * Other factors that, in the investigator's judgment, may affect subject safety or trial compliance, such as severe concomitant disease requiring treatment (including psychiatric disorders), severe laboratory abnormalities, or other family or social factors.
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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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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