{
    "info": {
        "nct_id": "NCT04255576",
        "official_title": "A Phase Ib/II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of JMT103 in Surgically Unsalvageable or Refractory Giant Cell Tumor of Bone",
        "inclusion_criteria": "1. Fully informed and signed informed consent.\n2. Male or female, Adults, 18 years and older\n3. Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose;\n2. Active dental or jaw condition which requires oral surgery, including tooth extraction;\n3. Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.);\n4. Concurrent treatment with bisphosphonates;\n5. Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Fully informed and signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Fully informed and signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fully informed and signed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male or female, Adults, 18 years and older",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Adults, 18 years and older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed GCTB",
                    "criterion": "GCTB",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically unsalvageable",
                    "criterion": "surgical salvageability",
                    "requirements": [
                        {
                            "requirement_type": "salvageability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planned surgery is associated with severe morbidity",
                    "criterion": "planned surgery morbidity",
                    "requirements": [
                        {
                            "requirement_type": "morbidity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose;",
            "criterions": [
                {
                    "exact_snippets": "Fertile subjects",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "refuse to use effective contraception methods",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "from the signing of the informed consent to 6 months after the last dose",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from the signing of the informed consent to 6 months after the last dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Active dental or jaw condition which requires oral surgery, including tooth extraction;",
            "criterions": [
                {
                    "exact_snippets": "Active dental or jaw condition which requires oral surgery",
                    "criterion": "dental or jaw condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requires oral surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active dental or jaw condition ... including tooth extraction",
                    "criterion": "dental or jaw condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "including tooth extraction"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.);",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.)",
                    "criterion": "anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Concurrent treatment with bisphosphonates;",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with bisphosphonates",
                    "criterion": "bisphosphonate treatment",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.",
            "criterions": [
                {
                    "exact_snippets": "Known history of second malignancy within the past 5 years",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for basal cell carcinoma or cervical carcinoma in situ",
                    "criterion": "second malignancy exceptions",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "basal cell carcinoma",
                                "cervical carcinoma in situ"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}