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RecruitingPhase 2NCT06587425

The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

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Trial Parameters

ConditionGastric or Gastroesophageal Junction Adenocarcinoma
SponsorShanghai Zhongshan Hospital
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment50
SexALL
Min Age18 Years
Max AgeN/A
Start Date2024-07-31
Completion2025-07-31
Interventions
LM-302+Candonilimab+Capecitabine

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Brief Summary

A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Inclusion Criteria: * The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as participants, and sign an informed consent form (ICF) before any procedures begin * The subject must have locally advanced or metastatic gastric cancer or gastroesophageal junction cancer that cannot be surgically removed, and the histopathological examination confirms it to be simple adenocarcinoma * Permissible Previous Treatment: Participants with gastric cancer or gastroesophageal junction cancer who have previously received adjuvant or neoadjuvant treatment and have experienced clinical disease progression at least 6 months after the last administration are eligible for inclusion. (Note: The treatment-related toxicity of oxaliplatin in previous adjuvant or neoadjuvant treatments must be restored to the National Cancer Institute \[NCI\] General Terminology Standard for Adverse Events \[CTCAE\] v5.0 Level 1 before enrollment) * CL

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