Immunotherapy plus chemotherapy before surgery shows promise against tough stomach cancers

NCT ID NCT07699939

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Aug 06, 2026 · Updated 6 times

Summary

This trial investigates whether adding the immunotherapy drug serplulimab (HLX10) to standard chemotherapy (S-1 and oxaliplatin) before and after surgery can improve outcomes for people with locally advanced, PD-L1-positive stomach or gastroesophageal junction cancer. Participants are randomly assigned to receive either the combination or chemotherapy alone, and the main goal is to see if the combination leads to a higher rate of complete tumor disappearance at the time of surgery. The study is double-blind and placebo-controlled to ensure reliable results.

What this could mean

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

Active substance
serplulimab (HLX10) plus S-1 and oxaliplatin
What this could lead to
If successful, this combination could become a new standard treatment to shrink tumors before surgery and reduce the chance of cancer returning in patients with advanced gastric cancer.
What could go wrong
This is a phase 2 trial with 136 participants, so results are preliminary. Adding immunotherapy to chemotherapy may increase side effects, and the benefit may not be confirmed in larger studies.

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 136 people

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

Started

Jul 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 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\) Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma at the study site. (For gastroesophageal junction adenocarcinoma, only patients classified as Siewert type II or type III who do not require surgery involving simultaneous thoracoabdominal incision are eligible.) * 2\) Tumor tissue determined to be PD-L1 positive (CPS \>= 5) based on pre-screening evaluation by the central laboratory. * 3\) Diagnosis of cT3-4N1-3M0 disease according to the AJCC/UICC-TNM 8th edition based on assessments performed within 28 days prior to randomization (the same day of the week 4 weeks before the randomization date is acceptable; the same applies hereafter), with no prior systemic treatment. Pre-randomization laparoscopy is not mandatory, but if performed, no non-curative factors (including liver metastasis, peritoneal metastasis, other distant metastases, or positive peritoneal cytology (CY1)) should be observed. * 4\) Judged by the investigator as capable of undergoing R0 resection. * 5\) Age between 18 years and 80 years on the day of enrollment. * 6\) ECOG performance status (PS) of 0 or 1. * 7\) The most recent laboratory values obtained within 14 days prior to randomization meet all of the following (however, transfusion, recombinant human thrombopoietin, and administration of granulocyte colony-stimulating factor (G-CSF) within 14 days prior to blood collection are not permitted): (1) Neutrophil count \>= 1500/mm\^3 (2) Hemoglobin \>= 9.0 g/dL (3) Platelet count \>= 10 x 10\^4/mm\^3 (4) Total bilirubin \<= 1.5 mg/dL (5) AST \<= 100 U/L (6) ALT \<= 100 U/L (7) Serum albumin \>= 3.0 g/dL (8) Serum creatinine \<= 1.5 mg/dL (9) APTT \<= 60 s (10) PT-INR \<= 1.5 * 8\) Females of childbearing potential should test negative for pregnancy test (serum or urine) within 7 days prior to randomization (the same day of the week is acceptable). * 9\) Male patients and females of childbearing potential agree to use contraception from the time of provision of informed consent through a specified period after the last administration of study treatment (until at least 120 days after the last dose of HLX10 and at least 180 days after the last dose of study drug other than HLX10 (S-1 or oxaliplatin)). * 10\) Written informed consent for study participation has been obtained from the patient. Exclusion Criteria: * 1\) Presence of another active malignancy within 5 years prior to enrollment or concurrently. Patients with cured, localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, non-invasive prostate cancer, non-invasive cervical cancer, and non-invasive breast cancer are permitted. * 2\) Patients scheduled to undergo organ transplantation or bone marrow transplantation. * 3\) Myocardial infarction and/or uncontrolled arrhythmia (including QTc interval \>= 450 ms in males or \>= 470 ms in females) occurring within 6 months prior to randomization (QTc interval calculated using Fridericia's formula). * 4\) Cardiac dysfunction classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) \< 50 percent on echocardiography. * 5\) Positive for any of the following: HIV antibody, HBs antigen, or HCV-RNA (HCV-RNA is measured only if HCV antibody is positive). * 6\) HBs antigen negative, HBs antibody and/or HBc antibody positive, and quantitative HBV-DNA detectable (patients are not excluded if HBV-DNA is below the limit of detection). * 7\) Active tuberculosis. * 8\) Interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and/or severe pulmonary dysfunction that may interfere with evaluation and management of suspected drug-related pulmonary toxicity. * 9\) Known active or suspected autoimmune disease, excluding patients whose disease is stable at randomization and who do not require systemic immunosuppressive therapy. * 10\) Patients who received live vaccination within 28 days prior to randomization, except for inactivated virus vaccines used for seasonal influenza prophylaxis. * 11\) Patients who require systemic corticosteroids (a therapeutic dose of \> 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days prior to randomization or during the study period. However, in the absence of active autoimmune disease, patients are permitted to use steroids at a dose of \<= 10 mg/day prednisone or equivalent, or inhaled steroids, or adrenal hormone replacement therapy. * 12\) Patients who have an active infection requiring systemic anti-infective treatment within 14 days prior to randomization, except for prophylactic antibiotic treatment (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease). * 13\) Prior treatment with other antibody or drug therapies for immune checkpoint blockade, such as PD-1, PD-L1, or CTLA-4 therapy. * 14\) Patients currently receiving other clinical study treatment, or for whom the planned start of treatment in this study is \< 14 days from completion of the prior clinical study treatment. * 15\) History of severe hypersensitivity to the monoclonal antibody or any component of the study drug. * 16\) History of psychotropic drug abuse or drug dependence. * 17\) Patients with a disease that may increase the risk associated with study participation and use of the study drug, or with other severe acute or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the study.

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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

    18 sites in 2 countries. 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

  • Ajou University Hospital

    NOT_YET_RECRUITING

    Suwon, Gyeonggi-do, South Korea

  • Asan Medical Center

    NOT_YET_RECRUITING

    Songpa-dong, South Korea

  • Cancer Institute Hospital of JFCR

    NOT_YET_RECRUITING

    Koto-Ku, Tokyo, Japan

  • Chiba Cancer Center

    RECRUITING

    Chiba, Chiba, 260-8717, Japan

  • Gifu University Hospital

    NOT_YET_RECRUITING

    Gifu, Gifu, Japan

  • Gunma University Hospital

    NOT_YET_RECRUITING

    Maebashi, Gunma, Japan

  • Hiroshima University Hospital

    NOT_YET_RECRUITING

    Hiroshima, Hiroshima, Japan

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    NOT_YET_RECRUITING

    Yokohama, Kanagawa, Japan

  • Kyushu Cancer Center

    RECRUITING

    Fukuoka, Fukuoka, 811-1395, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Korea

    NOT_YET_RECRUITING

    Goyang-si, Gyeonggi-do, South Korea

  • Osaka International Cancer Institute

    NOT_YET_RECRUITING

    Osaka, Osaka, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    RECRUITING

    Takatsuki, Osaka, Japan

  • Saitama Medical University International Medical Center

    NOT_YET_RECRUITING

    Hidaka, Saitama, Japan

  • Saitama Prefectural Cancer Center

    NOT_YET_RECRUITING

    Ina, Kitaadachi-gun, Japan

  • Seoul St. Mary's Hospital

    NOT_YET_RECRUITING

    Seocho, Seoul, South Korea

  • Shizuoka Cancer Center

    NOT_YET_RECRUITING

    Nagaizumi-chō, Sunto-gun, Japan

  • St. Marianna University Hospital

    RECRUITING

    Kawasaki, Kanagawa, Japan

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