Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ A… (NCT07569068) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ Adenocarcinoma
China88 participantsStarted 2026-04-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 cancerï¼›
* 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 …