{
    "info": {
        "nct_id": "NCT04913662",
        "official_title": "Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis",
        "inclusion_criteria": "* Pathologically diagnosed as gastric adenocarcinoma\n* Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis\n* HER-2 negative tumor\n* Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)\n* Absolute Neutrophil Count: ≧ 1,500/mm³\n* Hemoglobin level: ≧ 8.0g/dL\n* Platelet Count: ≧ 10×104/mm³\n* AST (GOT), ALT (GPT): ≦ 100U/L\n* Total Bilirubin: ≦ 2.0mg/dL\n* Creatinine Clearance (CCl): ≧ 50mL/min\n* ECOG 0 - 2\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Patients with other major medical disease or malignant tumors other than gastric cancer\n* Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel\n* Pregnant, breast-feeding women or with birth plan\n* History of gastrointestinal surgery\n* Patients refusing treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Pathologically diagnosed as gastric adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Pathologically diagnosed as gastric adenocarcinoma",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": "pathological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis",
            "criterions": [
                {
                    "exact_snippets": "Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis",
                    "criterion": "peritoneal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "suggestive evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER-2 negative tumor",
            "criterions": [
                {
                    "exact_snippets": "HER-2 negative tumor",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)",
            "criterions": [
                {
                    "exact_snippets": "Laboratory tests adequate for chemotherapy",
                    "criterion": "laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate for chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 2 weeks of enrollment",
                    "criterion": "timing of laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 2 weeks of enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute Neutrophil Count: ≧ 1,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "Absolute Neutrophil Count: ≧ 1,500/mm³",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin level: ≧ 8.0g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin level: ≧ 8.0g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet Count: ≧ 10×104/mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelet Count: ≧ 10×104/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "×104/mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total Bilirubin: ≦ 2.0mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Total Bilirubin: ≦ 2.0mg/dL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine Clearance (CCl): ≧ 50mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine Clearance (CCl): ≧ 50mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0 - 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0 - 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with other major medical disease or malignant tumors other than gastric cancer",
            "criterions": [
                {
                    "exact_snippets": "other major medical disease",
                    "criterion": "major medical disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant tumors other than gastric cancer",
                    "criterion": "malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than gastric cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to 5-FU",
                    "criterion": "5-FU",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindication to ... Oxaliplatin",
                    "criterion": "Oxaliplatin",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindication to ... Leukovorin",
                    "criterion": "Leukovorin",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindication to ... Paclitaxel",
                    "criterion": "Paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant, breast-feeding women or with birth plan",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "birth plan",
                    "criterion": "birth plan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of gastrointestinal surgery",
            "criterions": [
                {
                    "exact_snippets": "History of gastrointestinal surgery",
                    "criterion": "gastrointestinal surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients refusing treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients refusing treatment",
                    "criterion": "treatment refusal",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* AST (GOT), ALT (GPT): ≦ 100U/L",
            "criterions": [
                {
                    "exact_snippets": "AST (GOT): ≦ 100U/L",
                    "criterion": "AST (GOT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "U/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT (GPT): ≦ 100U/L",
                    "criterion": "ALT (GPT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "U/L"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}