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

NCT07569068 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Gastric or Esophagogastric Junction Adenocarcinoma

Interventions

DRUG

Tislelizumab, LM-302 and S-1

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.

DRUG

Tislelizumab combined with oxaliplatin and S-1

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-21
Primary Completion
2028-04-30
Completion
2029-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07569068 on ClinicalTrials.gov