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New drug cocktail targets hard-to-treat stomach cancer before surgery

NCT ID NCT07569068

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Phase 2

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

Participants

About 88 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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 years and older

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: * 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.

  1. The places running it

    1 site. 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

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Huangpu District, 200025, China

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Other studies related to the condition(s) this trial covers.