{
    "info": {
        "nct_id": "NCT06088472",
        "official_title": "A Single-arm Phase I Clinical Study of TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors",
        "inclusion_criteria": "* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;\n* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;\n* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥0.5cm (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);\n* 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);\n* 3. Arterial/venous thrombotic events within 5 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;\n* 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;\n* 5. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;\n* 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;\n* 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;",
            "criterions": [
                {
                    "exact_snippets": "ability to understand the requirements of the study",
                    "criterion": "ability to understand study requirements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC)",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;",
            "criterions": [
                {
                    "exact_snippets": "confirmed diagnosis of malignancy",
                    "criterion": "malignancy diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable recurrent or metastatic solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥0.5cm (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;",
            "criterions": [
                {
                    "exact_snippets": "At least one resectable lesion",
                    "criterion": "resectable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "preferably superficial metastatic lymph nodes",
                    "criterion": "superficial metastatic lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that has not been treated with radiation",
                    "criterion": "radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has not received other local therapies",
                    "criterion": "local therapies",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The separated tissues mass weighing ≥0.5cm",
                    "criterion": "separated tissues mass",
                    "requirements": [
                        {
                            "requirement_type": "weight",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "for the preparation of autologous tumor-infiltrating lymphocytes",
                    "criterion": "preparation of autologous tumor-infiltrating lymphocytes",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Minimally invasive treatment where possible",
                    "criterion": "minimally invasive treatment",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);",
            "criterions": [
                {
                    "exact_snippets": "symptomatic and/or untreated CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "stable brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "no medication required within 3 months",
                    "criterion": "medication requirement",
                    "requirements": [
                        {
                            "requirement_type": "time since last medication",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no hormone dependence",
                    "criterion": "hormone dependence",
                    "requirements": [
                        {
                            "requirement_type": "dependence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);",
            "criterions": [
                {
                    "exact_snippets": "any active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of autoimmune disease",
                    "criterion": "history of autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "need for systemic steroid hormones",
                    "criterion": "need for systemic steroid hormones",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone)",
                    "criterion": "condition requiring immunosuppressive drug therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3. Arterial/venous thrombotic events within 5 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;",
            "criterions": [
                {
                    "exact_snippets": "Arterial/venous thrombotic events within 5 months prior to enrollment",
                    "criterion": "arterial/venous thrombotic events",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "deep vein thrombosis",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;",
            "criterions": [
                {
                    "exact_snippets": "Active infections requiring treatment with systemic anti-infectives",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "systemic anti-infectives"
                        }
                    ]
                },
                {
                    "exact_snippets": "unexplained fever > 38.5℃ occurring during the screening period",
                    "criterion": "unexplained fever",
                    "requirements": [
                        {
                            "requirement_type": "temperature",
                            "expected_value": {
                                "operator": ">",
                                "value": 38.5,
                                "unit": "℃"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;",
            "criterions": [
                {
                    "exact_snippets": "refractory or intractable epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "refractory",
                                "intractable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "hydrops abdominis",
                    "criterion": "hydrops abdominis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "IL-2 contraindications",
                    "criterion": "IL-2 contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received allogeneic bone marrow transplantation",
                    "criterion": "allogeneic bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have received ... an organ allograft",
                    "criterion": "organ allograft",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);",
            "criterions": [
                {
                    "exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes",
                    "criterion": "hypersensitivity to autologous tumor infiltrating lymphocytes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... cyclophosphamide",
                    "criterion": "hypersensitivity to cyclophosphamide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... fludarabine",
                    "criterion": "hypersensitivity to fludarabine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... IL-2",
                    "criterion": "hypersensitivity to IL-2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... dimethyl sulfoxide (DMSO)",
                    "criterion": "hypersensitivity to dimethyl sulfoxide (DMSO)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... human serum albumin (HSA)",
                    "criterion": "hypersensitivity to human serum albumin (HSA)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... dextran-40",
                    "criterion": "hypersensitivity to dextran-40",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity to any component or excipient of study drugs: ... antibiotics (beta lactam antibiotics, gentamicin)",
                    "criterion": "hypersensitivity to antibiotics (beta lactam antibiotics, gentamicin)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}