New drug cocktail targets hard-to-treat stomach cancer before surgery
NCT ID NCT07569068
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a targeted drug (LM-302) to standard immunotherapy and chemotherapy before surgery can improve outcomes for people with a specific type of stomach cancer that has a protein called claudin 18.2. About 88 adults with advanced but removable stomach cancer will be randomly assigned to one of two treatment combinations. The main goal is to see how many patients have no cancer left in their removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tislelizumab, LM-302, S-1, and oxaliplatin
- What this could lead to
- If successful, this could offer a more effective pre-surgery treatment for a specific type of stomach cancer, potentially improving the chance of complete tumor removal.
- What could go wrong
- This is an early Phase 2 exploratory study with only 88 participants, so results may not apply broadly. The combination therapy may cause more side effects than standard treatment.
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 88 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 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 years and older
- 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: * Patients voluntarily participate in this study and sign the informed consent form; * Age ≥ 18 years; * Histopathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; * HER2 negative; * Determined by contrast-enhanced CT and laparoscopy to have radically resectable disease with clinical stage T3-4 N+ M0 (according to the AJCC 8th edition); * Claudin 18.2 positive (≥25% of tumor cells showing moderate-to-strong membrane staining); * No prior receipt of other targeted therapies against claudin 18.2; * ECOG performance status 0-1; * Life expectancy ≥ 12 months; * Adequate major organ function. Exclusion Criteria: * Known HER2-positive gastric cancer; * Gastroesophageal junction (EGJ) cancer involving the proximal stomach with the tumor center located ≤2 cm from the EGJ; * Peritoneal metastasis, positive peritoneal cytology (CY1P0), or retroperitoneal lymph node metastasis (No. 16a2/b1) or other distant metastases; * Presence of unresectable factors, including unresectability due to tumor characteristics, surgical contraindications, or patient refusal of surgery; * Prior or concurrent other malignancy, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast; * Presence of any of the following cardiac clinical symptoms or diseases: * New York Heart Association (NYHA) class ≥2 heart failure or left ventricular ejection fraction (LVEF) \<50% on color Doppler echocardiography; * Unstable angina; * Resting electrocardiogram (ECG) showing QTc \>450 ms (male) or QTc \>470 ms (female); * Resting ECG showing clinically significant abnormalities (e.g., abnormalities in heart rate, conduction, morphology), complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, or PR interval \>250 ms. * History of gastrointestinal perforation, intra-abdominal abscess, or intestinal obstruction within the past 3 months, or evidence of intestinal obstruction by imaging or clinical symptoms; * Arterial/venous thrombotic events within 6 months before randomization, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism; * Known hereditary or acquired bleeding or thrombotic predisposition (e.g., hemophilia, coagulation disorders, thrombocytopenia); * Active peptic ulcer, unhealed wound, or bone fracture; * Active infection requiring antimicrobial therapy (e.g., antibacterial, antiviral, or antifungal treatment); * Active hepatitis \[hepatitis B: HBsAg positive and HBV DNA ≥500 IU/mL; hepatitis C: HCV antibody positive and HCV viral load \> upper limit of normal\]; 13. Congenital or acquired immunodeficiency (e.g., HIV-infected patients); * Planned or prior organ or allogeneic bone marrow transplantation; * Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia/ lung disease requiring steroid therapy, or other pulmonary conditions that may interfere with the assessment and management of immune-related lung toxicity, including pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonia or severe pulmonary dysfunction on screening CT scan; * Active pulmonary tuberculosis; * Any active autoimmune disease or history of autoimmune disease with potential for relapse \[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controlled with hormone replacement therapy alone are eligible)\]; * Known hypersensitivity to any study drug or excipient; * Lactating women; * Any other condition that, in the investigator's judgment, may affect the study results or necessitate premature termination of the study, such as alcohol or drug abuse, other serious diseases (including psychiatric disorders) requiring concomitant treatment, significant laboratory abnormalities, or family/social factors that could compromise patient safety.
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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
1 site. 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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Ruijin Hospital Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Huangpu District, 200025, China
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Other studies related to the condition(s) this trial covers.