Actively Recruiting
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
Led by Ruijin Hospital · Updated on 2026-05-06
88
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates treatments for patients with Claudin 18.2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma. Researchers are comparing two neoadjuvant therapy combinations to evaluate their effects: one combines Tislelizumab with LM-302 and S-1, and the other combines Tislelizumab with SOX. The study is designed as a Phase 2, randomized, exploratory trial to understand the outcomes of these treatments in this specific cancer type. Participants receive either Tislelizumab 200mg with LM-302 2.0mg/kg through intravenous infusion on day 1 along with oral S-1 dosed by body surface area twice daily for 14 days every 3 weeks, or Tislelizumab 200mg with oxaliplatin 130 mg/m2 intravenous infusion plus oral S-1 following the same dosing schedule. The treatments are given before surgery in a neoadjuvant setting to assess their impact on the tumor. Throughout the study, participants will be monitored for pathological complete response rates over 24 months, along with treatment-related adverse events, major pathological response, R0 resection rates, event-free survival, and overall survival up to 36 months. The trial involves regular assessments including imaging and clinical evaluations to track effectiveness and safety. The total duration of follow-up will extend to three years to assess long-term outcomes and survival.
CONDITIONS
Brief Title
Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participate and sign informed consent
- Age 18 years or older
- Histopathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- HER2 negative
- Disease is radically resectable with clinical stage T3-4 N+ M0 by imaging and laparoscopy
- Claudin 18.2 positive with at least 25% tumor cells showing moderate-to-strong membrane staining
- No prior targeted therapies against claudin 18.2
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 months
- Adequate major organ function
You will not qualify if you...
- Known HER2-positive gastric cancer
- Gastroesophageal junction cancer with tumor center located 2 cm or less from the EGJ involving proximal stomach
- Peritoneal metastasis, positive peritoneal cytology, retroperitoneal lymph node metastasis, or other distant metastases
- Unresectable tumors, surgical contraindications, or patient refusal of surgery
- Prior or concurrent malignancy except cured basal cell carcinoma of the skin, carcinoma in situ of cervix or breast
- Cardiac conditions including NYHA class 2 or higher heart failure, unstable angina, or significant ECG abnormalities
- History of recent gastrointestinal perforation, intra-abdominal abscess or intestinal obstruction within 3 months
- Arterial or venous thrombotic events in the past 6 months
- Known bleeding or thrombotic disorders
- Active peptic ulcer, unhealed wounds, or bone fractures
- Active infections requiring antimicrobial therapy
- Active hepatitis B or C infection
- Congenital or acquired immunodeficiency including HIV
- Planned or prior organ or bone marrow transplantation
- Current or history of interstitial lung disease or severe pulmonary dysfunction
- Active pulmonary tuberculosis
- Active or history of autoimmune diseases with potential for relapse except controlled thyroid disorders
- Known hypersensitivity to study drugs or excipients
- Lactating women
- Other conditions that may affect study results or patient safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until surgery or discontinuation
Participants receive neoadjuvant treatment with either Tislelizumab combined with LM-302 and S-1 or Tislelizumab combined with oxaliplatin and S-1. Treatments include intravenous infusions on day 1 and oral medication taken twice daily for 14 days in repeated 3-week cycles.
Visits every 3 weeks corresponding to each treatment cycle
Trial Site Locations
Total: 1 location
1
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Huangpu District, China, 200025
Actively Recruiting
Research Team
Z
Zhongyin Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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