Can adding immunotherapy to chemotherapy keep stomach cancer at bay?

NCT ID NCT07772557

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 108 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

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

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: * 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

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