{
    "info": {
        "nct_id": "NCT06339060",
        "official_title": "An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy.",
        "inclusion_criteria": "* A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:\n\n  * Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma.\n  * Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n  * Patients approve and sign the informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients with active autoimmune disease or history of autoimmune disease.\n* Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.\n* Subjects with a history of symptomatic interstitial lung disease.\n* History of allergy to study drug components.\n* Women must not be pregnant or breast-feeding.\n* Men with female partners (WOCBP) that are not willing to use contraception.\n* Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.\n* medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cT2-T4a",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "cT"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "cT"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0-N+",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N+"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "resectable esophageal squamous cell carcinoma",
                    "criterion": "resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "esophageal squamous cell carcinoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "esophageal squamous cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients approve and sign the informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients approve and sign the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signature",
                            "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with active autoimmune disease or history of autoimmune disease.",
            "criterions": [
                {
                    "exact_snippets": "active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.",
            "criterions": [
                {
                    "exact_snippets": "condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications",
                    "criterion": "condition requiring systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "corticosteroids",
                                "immunosuppressive medications"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with a history of symptomatic interstitial lung disease.",
            "criterions": [
                {
                    "exact_snippets": "history of symptomatic interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergy to study drug components.",
            "criterions": [
                {
                    "exact_snippets": "History of allergy to study drug components.",
                    "criterion": "allergy to study drug components",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women must not be pregnant or breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": "Women must not be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women must not be ... breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men with female partners (WOCBP) that are not willing to use contraception.",
            "criterions": [
                {
                    "exact_snippets": "Men with female partners (WOCBP) that are not willing to use contraception.",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has received prior ... radiotherapy",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has received prior ... target therapy",
                    "criterion": "prior target therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has received prior ... immune therapy",
                    "criterion": "prior immune therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events",
            "criterions": [
                {
                    "exact_snippets": "medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "investigator's opinion",
                            "expected_value": "make the administration of study drug hazardous"
                        }
                    ]
                },
                {
                    "exact_snippets": "medical conditions that, in the Investigator's opinion, will ... obscure the interpretation of toxicity or adverse events",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "investigator's opinion",
                            "expected_value": "obscure the interpretation of toxicity or adverse events"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}