None listed
Conditions
Interventions
Drug, Medical Device, Procedure/Surgery : ¦ Intervention Group: Intraperitoneal Paclitaxel + Systemic Chemotherapy FOLFOX ± Immune Checkpoint Inhibitor (Nivolumab)
Intervention Details:
Drug Name: Pac
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Gastric Cancer: Histopathological diagnosis of adenocarcinoma First diagnosis of gastric cancer or recurrent gastric cancer Peritoneal metastasis confirmed by preoperative imaging or diagnostic laparoscopy Patients scheduled to receive first-line systemic chemotherapy Inclusion Criteria for Research Subjects: Laboratory tests performed within 14 days of enrollment showing the following bone marrow, liver, and kidney function: Neutrophil count: = 1,500/mm³ Hemoglobin level: = 8.0 g/dL Platelet count: = 10×104/mm³ AST (GOT) and ALT (GPT): = 100 U/L Total bilirubin: = 2.0 mg/dL Creatinine clearance (CCl): = 50 mL/min Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2 Negative HER-2 test Age: 19 years or older and under 80 years old Informed consent obtained for all procedures of the clinical trial.
Exclusion criteria
Exclusion criteria: Individuals currently undergoing acute treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, neurological, musculoskeletal, infectious, or psychiatric disorders Diagnosis of another malignancy within the last 5 years or currently receiving treatment for another malignancy Contraindications to the use of Fluorouracil, oxaliplatin, leucovorin, nivolumab, cisplatin, docetaxel, or paclitaxel (history of adverse reactions to these drugs, immune diseases, etc.) Receiving chronic systemic corticosteroid therapy with a dose greater than 10 mg of prednisone or an equivalent anti-inflammatory dose, or receiving any form of immunosuppressive therapy before Day 1 of Cycle 1 Receiving live vaccines for infectious diseases within 4 weeks prior to the start of the clinical trial treatment Pregnant or breastfeeding women Individuals who do not agree to contraception for 15 months after the last dose for women or 12 months for men Patients receiving total parenteral nutrition (TPN) Life expectancy of less than 3 months Presence of metastasis to other organs (excluding lymph node or ovary metastasis, which are not exclusion criteria for lymphatic metastasis) Patients with active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis Patients with human immunodeficiency virus (HIV) infection, active hepatitis B or C, or other inflammatory diseases Patients with bleeding disorders or a history of psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Overall Survival (OS);Toxicity and complication assessment using CTCAE;Tumor response assessment of target lesions;Change in Peritoneal Carcinomatosis Index (PCI) score;Conversion surgery rate;Quality of Life assessment using FACT G7 | — |
Countries
Korea, Republic of
Contacts
Public ContactSo Hyun Kang
Seoul National University Bundang Hospital
Outcome results
None listed