Immunotherapy plus chemotherapy before surgery shows promise against tough stomach cancers
NCT ID NCT07699939
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
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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 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 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\) 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.
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The places running it
18 sites in 2 countries. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Ajou University Hospital
NOT_YET_RECRUITINGSuwon, Gyeonggi-do, South Korea
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Asan Medical Center
NOT_YET_RECRUITINGSongpa-dong, South Korea
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Cancer Institute Hospital of JFCR
NOT_YET_RECRUITINGKoto-Ku, Tokyo, Japan
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Chiba Cancer Center
RECRUITINGChiba, Chiba, 260-8717, Japan
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Gifu University Hospital
NOT_YET_RECRUITINGGifu, Gifu, Japan
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Gunma University Hospital
NOT_YET_RECRUITINGMaebashi, Gunma, Japan
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Hiroshima University Hospital
NOT_YET_RECRUITINGHiroshima, Hiroshima, Japan
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Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
NOT_YET_RECRUITINGYokohama, Kanagawa, Japan
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Kyushu Cancer Center
RECRUITINGFukuoka, Fukuoka, 811-1395, Japan
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National Cancer Center Hospital
RECRUITINGChuo Ku, Tokyo, 104-0045, Japan
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National Cancer Center Korea
NOT_YET_RECRUITINGGoyang-si, Gyeonggi-do, South Korea
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Osaka International Cancer Institute
NOT_YET_RECRUITINGOsaka, Osaka, Japan
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Osaka Medical and Pharmaceutical University Hospital
RECRUITINGTakatsuki, Osaka, Japan
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Saitama Medical University International Medical Center
NOT_YET_RECRUITINGHidaka, Saitama, Japan
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Saitama Prefectural Cancer Center
NOT_YET_RECRUITINGIna, Kitaadachi-gun, Japan
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Seoul St. Mary's Hospital
NOT_YET_RECRUITINGSeocho, Seoul, South Korea
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Shizuoka Cancer Center
NOT_YET_RECRUITINGNagaizumi-chō, Sunto-gun, Japan
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St. Marianna University Hospital
RECRUITINGKawasaki, Kanagawa, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One small incision vs several: robotic stomach cancer surgery put to the test
- Can PET scans reveal which stomach cancers will respond to immunotherapy?
- Can a direct hit to tumors make immunotherapy work better?
- Can a vaccine stop GI cancers from returning?
- Blood test aims to catch Cancer's return earlier
- Blood test guides immunotherapy for hidden cancer cells