CLDN18.2-positive gastric cancer with peritoneal metastasis
Conditions
Interventions
Experimental group:zolbetuximab and tislelizumab combined with normothermic intraperitoneal and systemic treatment
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form, understand this research, and be willing to follow and have the ability to complete all the trial procedures. 2.Age >= 18 years old, male or female; 3.Gastric adenocarcinoma diagnosed by histopathology; 4.For gastric cancer with peritoneal metastasis, laparoscopic examination is necessary for a clear diagnosis, but there should be no obstruction of the gastric outflow tract or intestinal obstruction. 5. After confirmation by the central laboratory, the tumor tissue was found to be positive for CLDN18.2 (defined as immunohistochemical detection showing that >= 75% of the tumor cells had membrane staining of CLDN18.2 >= 2+); 6. ECOG score of 0 to 2 points; 7. Expected survival period > 3 months; 8. With fully functional organs and bone marrow, as defined below: • Blood routine: Absolute neutrophil count >= 1.5 × 10^9/L; Platelet count >= 100 × 10^9/L; Hemoglobin content >= 9.0 g/dL. • Liver function: Serum total bilirubin (TBIL) = 50 mL/min; Urine test strip results show urine protein < 2+. • Coagulation function: Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 × ULN. • Thyroid function is normal, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, patients with total T3 (or FT3) and FT4 within the normal range can also be included; • Myocardial enzyme spectrum is within the normal range (such as if the study investigator determines that a purely laboratory abnormality without clinical significance is allowed for inclusion).
Exclusion criteria
Exclusion criteria: 1.With distant metastasis other than peritoneal metastasis at the time of selection; 2. Pregnant or lactating women; 3. Those who have a history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ; 4. Those who have received other targeted CLDN18.2 treatments (including CLDN18.2 monoclonal antibody, ADC, dual antibody, CART, etc.); 5.Those who have received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another type of stimulatory or synergistic inhibitory T-cell receptor (such as CTLA-4, OX-40, CD137); 6.Those who have received chemotherapy or radiotherapy for gastric cancer in the past; 7.Those with uncontrolled epilepsy, central nervous system diseases or mental disorders, and the clinical severity is judged by the investigator to prevent signing the informed consent form or affect the patient's oral medication compliance; 8.Severe (i.e., active) heart disease, such as symptomatic coronary heart disease, NYHA class II or more severe congestive heart failure or severe drug intervention arrhythmia within the last 12 months, or a history of myocardial infarction, or severe (i.e., active) heart valve disease, dilated or hypertrophic cardiomyopathy; 9.Upper gastrointestinal obstruction or abnormal physiological functions or patients with malabsorption syndrome, which may affect the absorption of S-1; 10. Known peripheral nerve disease >= grade 1 according to the common toxicity criteria of the National Cancer Institute (NCI-CTC). However, patients with only disappearance of deep tendon reflex (DTR) can be excluded; 11.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12.Severe uncontrolled infectious diseases, HIV-infected individuals, uncontrolled active HBV, active HCV-infected individuals; 13.Moderate or severe renal impairment (creatinine clearance rate upper limit of normal; 14.Known to have dihydropyridine dehydrogenase (DPD) deficiency; 15.Interstitial pneumonia, interstitial lung disease or active tuberculosis, or other pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or patients with active pneumonia or severe pulmonary function impairment shown by CT during the screening period; 16.Any active autoimmune disease or those with a history of autoimmune disease and a possible recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, thyroiditis); 17.Uncontrolled diabetes or hypertension; 18.Body temperature >= 38.0?; 19.Emergency surgery; 20.Within 7 days before the first administration of the study drug, those who are receiving systemic glucocorticoid therapy (excluding nasal, inhalation or other routes of local glucocorticoids) or any other form of immunosuppressive therapy; 21.Allergic to paclitaxel or any component of the study drug; 22.HER-2 positive (immunohistochemistry 2+ and FISH amplification, or immunohistochemistry 3+); 23.Within 30 days before the first administration (cycle 1, day 1) vaccinated with live vaccine; 24.Currently participating in other interventional clinical studies for treatment; 25.Existing medical conditions that may or will interfere with the research process (including follow-up and compliance).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;1-year progression-free survival rate;Conversion surgery rate;The incidence of postoperative complications;The incidence rate of treatment-related adverse reactions; | — |
Countries
China
Contacts
Public ContactChao Yan
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed