Actively Recruiting
Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis
Led by Ruijin Hospital · Updated on 2026-02-18
40
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment regimen combining Cadonilimab, LM-302, S-1, and intraperitoneal infusion of paclitaxel for patients with Claudin 18.2-positive gastric cancer that has spread to the peritoneum. This phase 2 study aims to assess the effectiveness and safety of this combination in treating stage IV gastric cancer with peritoneal metastasis. Participants receive Cadonilimab (10 mg/kg) and LM-302 (2.0 mg/kg) through intravenous infusion on day 1, along with paclitaxel (20 mg/m2) administered directly into the peritoneal cavity on days 1 and 8. Additionally, oral S-1 (80 mg/m2) is taken daily for 14 consecutive days, repeated every 3 weeks. This regimen is designed to deliver systemic and local treatments targeting cancer cells. During the study, researchers monitor participants for up to 36 months, focusing on survival rates, response to treatment, progression-free survival, and any adverse events. Assessments include tracking treatment-related side effects, response evaluations, and surgery outcomes if applicable. Participants are followed closely to evaluate both the benefits and risks of the treatment combination over time.
CONDITIONS
Brief 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 for primary or metastatic lesions
- Peritoneal metastases diagnosed by laparoscopy without gastric outflow tract or intestinal obstruction
- Claudin 18.2 positive in at least 25% of tumor cells with at least 70% of cases having over 50% positive cells
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Expected life expectancy greater than 3 months
- Adequate bone marrow, liver, and kidney function
You will not qualify if you...
- Evidence of distant metastases outside the peritoneal cavity (e.g., liver, lung, para-aortic lymph nodes)
- Pregnant, within 28 days postpartum, or breastfeeding
- Previous immunotherapy (PD-1/PD-L1 or CTLA-4) or Claudin 18.2-targeted therapy
- Other cancers diagnosed within the past 5 years
- Severe mental illness, uncontrolled epilepsy, or central nervous system disorders
- Active severe heart disease or recent myocardial infarction within 12 months
- Upper gastrointestinal obstruction or malabsorption affecting S-1 absorption
- Known peripheral neuropathy greater than grade 1
- Use of steroids or immunosuppressants after organ transplant
- Severe uncontrolled infections or other serious diseases
- Moderate to severe kidney damage (creatinine clearance ≤ 50 ml/min or serum creatinine above normal)
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Allergy to paclitaxel or any study drug components
- Active or refractory autoimmune disease
- HIV positive or active hepatitis B or C infection
- Systemic immunosuppressive therapy within 14 days before enrollment (except low-dose steroids for allergy prevention)
- Uncontrolled arrhythmia or active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 systemic intravenous infusions of Cadonilimab and LM-302 on day 1, intraperitoneal paclitaxel infusions on days 1 and 8, and oral S-1 for 14 consecutive days every 3 weeks.
Multiple visits every 3 weeks for infusions and daily oral medication for 14 days per cycle
Duration - Up to 36 months after treatment
Participants are monitored for survival, response to treatment, and adverse events after completing treatment.
Periodic visits for 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, PhD
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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