Advanced or recurrent gastric or gastroesophageal junction cancer with peritoneal dissemination
Conditions
Interventions
ASO-4733 will be administered intraperitoneally weekly starting from Day 1. SOX will be administered in two cycles, with each cycle lasting three weeks starting from Day 1.
Sponsors
Kanda Mitsuro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with advanced or recurrent adenocarcinoma of the stomach or gastroesophageal junction with histologically confirmed. 2. Patients with peritoneal dissemination confirmed by imaging or diagnostic laparoscopy, or patients with positive peritoneal cytology. 3. Patients who have not received chemotherapy excepting perioperative chemotherapy or radiotherapy for gastric or gastroesophageal junction cancer in the past. 4. Patients with HER2-negative status (IHC 1+ or less, or 2+ and ISH-negative). 5. Patients with a PD-L1 expression rate (Combined Positive Score (CPS)) of less than 10. However, for patients with CPS of 1 or more, participation in this clinical trial is allowed if they have been fully informed about the efficacy and safety of immune checkpoint inhibitors in gastric cancer patients with 1 <= CPS < 10 and have given consent. 6. Patients with CLDN18.2-negative status. However, patients with CLDN18.2-positive status can be enrolled if: They have refused zolbetuximab administration although they have been fully informed about efficacy and adversed events of zolbetuximab. They have refused both FOLFOX and CAPOX administration. 7. Patients with adequate bone marrow and major organ function and with ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0-2 8. Patients expected to survive for more than 3 months after the start of treatment. 9. Patients who can undergo intraperitoneal port implantation under general anesthesia. 10. Patients aged 18 years or older and younger than 80 years at the time of consent. 11. Patients who can take oral intake. 12. Male patients or female patients with childbearing potential who can use contraception during a defined period. 13. Patients who have received sufficient explanation about participation in this study, fully understand it, and have given written consent of their own free will.
Exclusion criteria
Exclusion criteria: 1. Patients with the following comorbidities: Uncontrolled heart disease (congestive heart failure, myocardial infarction or unstable angina within one year prior to registration, arrhythmias requiring treatment, etc.) Uncontrolled diabetes or hypertension Active autoimmune diseases requiring systemic steroid administration or immunosuppressive therapy Infections requiring systemic administration of antibiotics, antiviral drugs, etc. 2. Patients with confirmed brain metastases (if brain metastasis symptoms are present, confirm with head CT or MRI) 3. Patients with comorbid or a history of interstitial lung disease 4. Patients requiring ascites drainage for symptom relief 5. Patients meeting any of the following criteria: Patients positive for HBs antigen, or patients positive for HBs antibody or HBc antibody and HBV-DNA Patients positive for HCV antibody and HCV-RNA Patients positive for HIV antibody 6. Patients with Grade 2 or higher peripheral sensory or motor neuropathy 7. Patients with active double cancer (borderline malignant lesions, carcinoma in situ or mucosal cancer equivalent lesions judged to be cured by local treatment are not included as double cancer) 8. Patients contraindicated for administration of S-1 and oxaliplatin 9. Pregnant or breastfeeding female patients (except those who discontinue breastfeeding and do not resume) 10. Male patients with a female partner wishing to become pregnant and female patients wishing to become pregnant 11. Other patients deemed inappropriate for participation in this clinical trial by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT (Dose-Limiting Toxicity), Safety, Drug Pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS), Progression-Free Survival (PFS), Response Rate (based on RECIST ver1.1), Pharmacokinetics in Ascites, Blood and Ascites Drug Concentrations on Days 8, 15, and 22, Negative rate on Peritoneal Cytology | — |
Contacts
Public ContactNao Takano
Nagoya University Hospital
Outcome results
None listed