Actively Recruiting
Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis
Led by Ruijin Hospital · Updated on 2026-02-18
40
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this phase 2 study, we combined Cadonilimab, LM-302, and S-1 combined with intraperitoneal infusion of paclitaxel as regimen to treat gastric cancer patients with peritoneal metastasis.
CONDITIONS
Official Title
Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed gastric adenocarcinoma with HER2 negative status and no prior surgery to primary or metastatic lesions
- Presence of peritoneal metastases confirmed by laparoscopy without gastric outflow or intestinal obstruction
- Claudin 18.2 positive tumor with at least 25% positive cells and at least 70% of cases showing more than 50% positive cells
- Age 18 years or older at registration
- 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 outside the peritoneum, such as liver, lung, or para-aortic lymph node metastases
- Pregnancy, lactation, or within 28 days post childbirth
- Prior immunotherapy with PD-1/PD-L1 or CTLA-4 inhibitors or targeted therapy against Claudin 18.2
- Other cancers diagnosed within the past 5 years
- Severe mental illness, uncontrolled epilepsy, or central nervous system diseases
- Severe active heart disease including symptomatic coronary heart disease, NYHA class II or worse heart failure, arrhythmia requiring treatment, or recent myocardial infarction within 12 months
- Severe gastrointestinal obstruction or malabsorption affecting S-1 absorption
- Known peripheral neuropathy worse than grade 1, except absent deep tendon reflex only
- Use of steroids or immunosuppressants after organ transplant
- Severe uncontrolled infections or other serious diseases
- Moderate to severe kidney damage or elevated creatinine above normal limits
- Known dihydropyrimidine dehydrogenase deficiency
- Allergy to paclitaxel or any study drug ingredients
- Active or refractory autoimmune disease
- HIV positive or active hepatitis B or C infections requiring treatment
- Use of systemic immunosuppressive therapy within 14 days before admission, except low-dose steroids for allergies
- Uncontrolled arrhythmia, recent myocardial infarction within 12 months, or active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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