NCT07556640
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- 1-year survival rate
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
- •Age ≥ 18 years at registration;
- •Peritoneal metastases from gastric cancer requiring definitive diagnosisby laparoscopy, and without gastric outflow tract obstruction andintestinal obstruction;
- •Claudin 18.2 positive (≥ 25%, moderate to strong staining);
- •Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
- •Expected life expectancy \> 3 months;
- •Adequate bone marrow, liver, and renal functions.
Exclusion Criteria
- •Presence of distant metastases other than peritoneal metastasis at the time of enrollment;
- •Pregnant or breastfeeding women;
- •Prior treatment with Claudin 18.2 targeted therapy;
- •History of other malignancies within the past 5 years, except for cured skin cancer or cervical carcinoma in situ;
- •History of uncontrolled epilepsy, central nervous system disease, or mental disorder that, in the investigator's judgment, may interfere with signing informed consent or compliance with oral medication.
- •Clinically significant active heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher congestive heart failure, severe arrhythmia requiring medication, or myocardial infarction within the past 12 months;
- •Upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect S 1 absorption;
- •Known peripheral neuropathy ≥ NCI CTC AE grade
- •However, patients with loss of deep tendon reflexes (DTR) alone may be included;
- •Organ transplantation requiring immunosuppressive therapy;
Arms & Interventions
LM-302 and S-1 Plus Intraperitoneal Paclitaxel
Experimental
Intervention: LM-302, S-1, paclitaxel (Drug)
LM-302 and S-1 Plus Intraperitoneal Paclitaxel combined with Cadonilimab
Active Comparator
Intervention: LM-302, Cadonilimab, S-1, paclitaxel (Drug)
Outcomes
Primary Outcomes
1-year survival rate
Time Frame: up to 24 months
Secondary Outcomes
- treatment related adverse events(up to 24 months)
- Progressive free survival (PFS)(up to 36 months)
- Overall survival (OS)(up to 36 months)
- Disease control rate (DCR)(up to 24 months)
- Objective response rate (ORR)(up to 24 months)
- Major Pathological Response (MPR) rate(up to 24 months)
Investigators
Zhongyin Yang, MD., PhD
Doctor
Ruijin Hospital
Study Sites (1)
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