{
    "info": {
        "nct_id": "NCT05001360",
        "official_title": "Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer",
        "inclusion_criteria": "* Voluntarily participate in this study and provide written informed consent\n* Age ≥ 18 years and ≤70 years, male or female\n* Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies\n* Able and willing to provide tumor tissue\n* At least one measurable extracranial target lesion according to iRECIST\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Life expectancy ≥3 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin\n* Had systemic diseases that were difficult to control within 4 weeks prior to screening\n* History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy\n* History of coagulation disorders\n* Mechanical or paralytic obstruction of the gastrointestinal tract\n* Anticipated to receive a great number of antibiotics during study period",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Voluntarily participate in this study and provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily participate in this study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provide written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years and ≤70 years, male or female",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years and ≤70 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies",
            "criterions": [
                {
                    "exact_snippets": "Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathological"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Pathological confirmed locally advanced, unresectable or metastatic ... esophagogastric junction adenocarcinoma",
                    "criterion": "esophagogastric junction adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathological"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Pathological confirmed locally advanced, unresectable or metastatic ... lower esophagus adenocarcinoma",
                    "criterion": "lower esophagus adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathological"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "resistant to anti-PD-1/L1 antibodies",
                    "criterion": "resistance to anti-PD-1/L1 antibodies",
                    "requirements": [
                        {
                            "requirement_type": "resistance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able and willing to provide tumor tissue",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to provide tumor tissue",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one measurable extracranial target lesion according to iRECIST",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable extracranial target lesion according to iRECIST",
                    "criterion": "extracranial target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "criteria",
                            "expected_value": "iRECIST"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": "History of other primary malignancies within 5 years",
                    "criterion": "history of other primary malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanoma carcinoma of the skin",
                    "criterion": "non-melanoma carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had systemic diseases that were difficult to control within 4 weeks prior to screening",
            "criterions": [
                {
                    "exact_snippets": "systemic diseases that were difficult to control",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "control difficulty",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior to screening",
                    "criterion": "time since control difficulty",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy",
            "criterions": [
                {
                    "exact_snippets": "History of anti-PD-1 antibodies related adverse reactions",
                    "criterion": "anti-PD-1 antibodies related adverse reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "led to the permanent withdrawal of anti-PD-1 therapy",
                    "criterion": "permanent withdrawal of anti-PD-1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "anti-PD-1 antibodies related adverse reactions"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of coagulation disorders",
            "criterions": [
                {
                    "exact_snippets": "History of coagulation disorders",
                    "criterion": "coagulation disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mechanical or paralytic obstruction of the gastrointestinal tract",
            "criterions": [
                {
                    "exact_snippets": "Mechanical or paralytic obstruction of the gastrointestinal tract",
                    "criterion": "obstruction of the gastrointestinal tract",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "mechanical",
                                "paralytic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anticipated to receive a great number of antibiotics during study period",
            "criterions": [
                {
                    "exact_snippets": "Anticipated to receive a great number of antibiotics",
                    "criterion": "antibiotic administration",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "great number"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}