Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07556640

LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study

Led by Ruijin Hospital · Updated on 2026-04-29

74

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.

CONDITIONS

Official Title

LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with HER2 negative status and no history of surgery on primary or metastatic lesions
  • Age 18 years or older at registration
  • Peritoneal metastases from gastric cancer confirmed by laparoscopy, without gastric outflow tract or intestinal obstruction
  • Claudin 18.2 positive with at least 25% moderate to strong staining
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Expected life expectancy greater than 3 months
  • Adequate bone marrow, liver, and kidney function
Not Eligible

You will not qualify if you...

  • Presence of distant metastases other than peritoneal metastasis at enrollment
  • Pregnant or breastfeeding women
  • Previous treatment with Claudin 18.2 targeted therapy
  • History of other cancers within the past 5 years, except cured skin cancer or cervical carcinoma in situ
  • Uncontrolled epilepsy, central nervous system disease, or mental disorders interfering with consent or medication compliance
  • Significant active heart disease including symptomatic coronary artery disease, NYHA class II or higher heart failure, severe arrhythmia needing medication, or heart attack within past 12 months
  • Upper gastrointestinal obstruction, abnormal digestive function, or malabsorption affecting S-1 absorption
  • Peripheral neuropathy grade 1 or higher, except loss of deep tendon reflexes alone
  • Organ transplant requiring immunosuppressive therapy
  • Severe uncontrolled infection or other severe diseases
  • Moderate or severe kidney impairment (creatinine clearance 50 ml/min or less) or elevated serum creatinine
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Active hepatitis B or C infection
  • Psychiatric disorders preventing treatment compliance
  • Allergy to paclitaxel or any study drug components
  • Any other condition that may affect study results or participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Huangpu District, China, 200025

Actively Recruiting

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Research Team

Z

Zhongyin Yang

CONTACT

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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