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Gastric or Esophagogastric Junction AdenocarcinomaPhase 2NCT07569068

Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ Adenocarcinoma

A Phase 2 study testing Tislelizumab, LM-302 and S-1 and Tislelizumab combined with oxaliplatin and S-1 in people with Gastric or Esophagogastric Junction Adenocarcinoma, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In this study, the investigators will use Tislelizumab combined with LM-302 and S-1 versus Tislelizumab combined with SOX to treat Claudin 18.2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tislelizumab, LM-302 and S-1 and Tislelizumab combined with oxaliplatin and S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
21 Apr 2026to 30 Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • No prior receipt of other targeted therapies against claudin 18.2;
  • ECOG performance status 0-1;
  • Life expectancy ≥ 12 months;
  • Adequate major organ function.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhongyin Yang contact

8621-64370045

jeffreyyong@163.com

China1 site, 1 recruiting

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Huangpu District, 200025

    Recruiting

Other trials in China

About this study

Official title: Tislelizumab Combined With LM-302 and S-1 Versus Tislelizumab Combined With SOX for Neoadjuvant Treatment of Claudin 18.2-positive Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Prospective, Randomized, Exploratory Study

In this study, the investigators will use Tislelizumab combined with LM-302 and S-1 versus Tislelizumab combined with SOX to treat Claudin 18.2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma.

Being tested
Tislelizumab, LM-302 and S-1, Tislelizumab combined with oxaliplatin and S-1
Keywords
Gastric or Esophagogastric Junction Adenocarcinoma, Claudin 18.2, LM-302, Tislelizumab, SOX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab, LM-302 and S-1Drug

    Tislelizumab 200mg and LM-302 2.0mg/kg intravenous (IV) infusion on day 1 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.

  • Tislelizumab combined with oxaliplatin and S-1Drug

    Tislelizumab 200mg and oxaliplatin 130 mg/m2 intravenous (IV) infusion on day 1 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.

Study groups in NCT07569068
Study groupRoleWhat they receive
Tislelizumab Combined With LM-302 and S-1ExperimentalNot described
Receives: Drug: Tislelizumab, LM-302 and S-1
Tislelizumab Combined With SOXActive comparatorNot described
Receives: Drug: Tislelizumab combined with oxaliplatin and S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR) rate

    pCR is defined as the absence of residual tumor based on evaluation of the resected stomach and lymph node specimen according to Becker remission criteria

    Measured: up to 24 months

Secondary outcomes (6)

  1. treatment related adverse events

    Measured: up to 24 months

  2. Major Pathological Response (MPR) rate

    Defined as tumor specimens resected after neoadjuvant therapy with residual tumor cells ≤10%

    Measured: up to 24 months

  3. R0 resection rate

    R0 resection rate was defined as the proportion of patients with complete resection of the tumor and negative margins, i.e. no residual tumors

    Measured: up to 24 months

  4. Event-free survival (EFS)

    Event-free survival (EFS) is defined as the time from treatment initiation until the occurrence of any predefined event, including disease progression preventing planned surgery, local or distant recurrence, or death from any cause

    Measured: up to 36 months

  5. Overall survival (OS)

    Overall survival (OS) is defined as the period from the initial date of neoadjuvant therapy to the date of death due to any cause.

    Measured: up to 36 months

  6. treatment related adverse events

    It is defined according to the AJCC 8th edition ypN staging system, with the ypN0 rate and total number of positive lymph nodes in the two groups.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start21 Apr 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07569068
Sponsor's protocol ID
DRAGON-18
Status last verified
May 2026
First submitted
17 Apr 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, LM-302 and S-1 and Tislelizumab combined with oxaliplatin and S-1 in people with Gastric or Esophagogastric Junction Adenocarcinoma, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhongyin Yang (8621-64370045, jeffreyyong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07569068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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