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RECRUITING
NCT07569068
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2026-04-21

Completion Date

2029-04-30

Last Updated

2026-05-06

Healthy Volunteers

No

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.

Locations (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Huangpu District, China