Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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