Actively Recruiting
LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis: a Prospective, Exploratory Study
Led by Ruijin Hospital · Updated on 2026-04-29
74
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis. This Phase 2 study aims to explore the effects of LM-302 and S-1 combined with intraperitoneal paclitaxel, with or without the addition of Cadonilimab. The study focuses on patients with advanced cancer that has spread to the lining of the abdomen and who meet specific diagnostic criteria. Participants will be randomly assigned to one of two treatment groups. The first group receives LM-302 intravenous infusion, intraperitoneal paclitaxel on days 1 and 8, and oral S-1 based on body surface area taken twice daily for 14 days every 3 weeks. The second group receives the same regimen with the addition of Cadonilimab intravenous infusion on day 1. Treatment cycles repeat every three weeks, with monitoring continuing for up to 36 months. Throughout the study, participants will undergo regular assessments including survival rates at one year, progression-free survival, overall survival, disease control, response rates, and pathological responses. Researchers will also monitor treatment-related side effects for up to 24 months. The total follow-up may last up to three years, with ongoing evaluations to assess safety and effectiveness of the treatments.
CONDITIONS
Brief 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 prior resection of primary or metastatic lesions
- Age 18 years or older at registration
- Peritoneal metastases from gastric cancer confirmed by laparoscopy without gastric outflow 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
- Prior treatment targeting Claudin 18.2
- 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 disorder affecting consent or treatment compliance
- Significant active heart disease such as symptomatic coronary artery disease, congestive heart failure class II or higher, severe arrhythmia requiring medication, or recent myocardial infarction within 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 transplantation requiring immunosuppressive therapy
- Severe uncontrolled infection or other serious diseases
- Moderate to severe kidney impairment (creatinine clearance ≤ 50 ml/min) or high serum creatinine
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Active hepatitis B or C infection with high viral load
- Psychiatric disorders preventing treatment compliance
- Allergy to paclitaxel or any study drug components
- Any condition that may interfere with study results or full participation as judged by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab as part of their treatment.
Intravenous and intraperitoneal infusions on Days 1 and 8 of each cycle, with oral medication taken Days 1-14
Duration - Up to 36 months
Participants are monitored for survival, disease progression, and treatment-related adverse events after treatment ends.
Periodic visits for assessments up to 36 months
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
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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