{
    "info": {
        "nct_id": "NCT03940001",
        "official_title": "A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed esophageal squamous carcinoma\n* 18≤age≤75\n* ECOG PS is 0-1\n* TanyN+M0 or T3-4NanyM0 tumors\n* Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon\n* No prior chemotherapy,radiotherapy and immunotherapy\n* Disease must be clinically limited to the esophagus\n* No esophageal perforation and no active esophageal bleeding\n* No interstitial pneumonia or history of interstitial pneumonia\n* FEV1>1.2L\n* Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance >40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Frediricia's Correction\n* Able to provide written informed consent\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Previous treatment with chemotherapy, radiotherapy or immunotherapy\n* Cervical esophageal cancer\n* Esophageal perforation or active esophageal bleeding\n* Interstitial pneumonia or history of interstitial pneumonia\n* Patients with evidence of metastatic disease\n* Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible\n* Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis)\n* 14 days before the first dose, the patient had an active infection that required systemic treatment\n* Inability to understand or may not comply with test requirements",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed esophageal squamous carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed esophageal squamous carcinoma",
                    "criterion": "esophageal squamous carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18≤age≤75",
            "criterions": [
                {
                    "exact_snippets": "18≤age≤75",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG PS is 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS is 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": "* TanyN+M0 or T3-4NanyM0 tumors",
            "criterions": [
                {
                    "exact_snippets": "TanyN+M0",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "T stage",
                            "expected_value": "any"
                        },
                        {
                            "requirement_type": "N stage",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "M stage",
                            "expected_value": "0"
                        }
                    ]
                },
                {
                    "exact_snippets": "T3-4NanyM0",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "T stage",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        },
                        {
                            "requirement_type": "N stage",
                            "expected_value": "any"
                        },
                        {
                            "requirement_type": "M stage",
                            "expected_value": "0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon",
            "criterions": [
                {
                    "exact_snippets": "surgically resectable disease",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatable by esophagectomy",
                    "criterion": "treatment method",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "esophagectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "as assessed by a thoracic surgeon",
                    "criterion": "assessment by thoracic surgeon",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy,radiotherapy and immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... radiotherapy",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... immunotherapy",
                    "criterion": "prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease must be clinically limited to the esophagus",
            "criterions": [
                {
                    "exact_snippets": "Disease must be clinically limited to the esophagus",
                    "criterion": "disease location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "esophagus"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No esophageal perforation and no active esophageal bleeding",
            "criterions": [
                {
                    "exact_snippets": "No esophageal perforation",
                    "criterion": "esophageal perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no active esophageal bleeding",
                    "criterion": "active esophageal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No interstitial pneumonia or history of interstitial pneumonia",
            "criterions": [
                {
                    "exact_snippets": "No interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of interstitial pneumonia",
                    "criterion": "history of interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FEV1>1.2L",
            "criterions": [
                {
                    "exact_snippets": "FEV1>1.2L",
                    "criterion": "FEV1",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.2,
                                "unit": "L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance >40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Frediricia's Correction",
            "criterions": [
                {
                    "exact_snippets": "WBC ≥3,000/ L",
                    "criterion": "white blood cell count (WBC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ANC ≥1,500/ L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets ≥100,000/ L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hb ≥9 g/dl",
                    "criterion": "hemoglobin (Hb)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Calculated creatinine clearance >40 ml/min using Cockcroft-Gault method",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total serum bilirubin ≤1.5 mg/dL",
                    "criterion": "total serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST/ALT ≤2.5× upper limit of normal",
                    "criterion": "AST/ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Frediricia's Correction",
                    "criterion": "QT interval corrected for heart rate (QTc)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to provide written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up",
            "criterions": [
                {
                    "exact_snippets": "Subject is willing and able to comply with the protocol",
                    "criterion": "willingness and ability to comply with protocol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing treatment",
                    "criterion": "undergoing treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled visits and examinations",
                    "criterion": "attendance of scheduled visits and examinations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including follow up",
                    "criterion": "follow-up attendance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* Previous treatment with chemotherapy, radiotherapy or immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with chemotherapy",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with ... radiotherapy",
                    "criterion": "radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with ... immunotherapy",
                    "criterion": "immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cervical esophageal cancer",
            "criterions": [
                {
                    "exact_snippets": "Cervical esophageal cancer",
                    "criterion": "cervical esophageal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Esophageal perforation or active esophageal bleeding",
            "criterions": [
                {
                    "exact_snippets": "Esophageal perforation",
                    "criterion": "esophageal perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active esophageal bleeding",
                    "criterion": "esophageal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interstitial pneumonia or history of interstitial pneumonia",
            "criterions": [
                {
                    "exact_snippets": "Interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with evidence of metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible",
            "criterions": [
                {
                    "exact_snippets": "Chronic Hepatitis B or C infection",
                    "criterion": "Chronic Hepatitis B or C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis B surface Ag positive",
                    "criterion": "Hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "detectable viral load for Hepatitis B or C",
                    "criterion": "detectable viral load for Hepatitis B or C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 14 days before the first dose, the patient had an active infection that required systemic treatment",
            "criterions": [
                {
                    "exact_snippets": "14 days before the first dose, the patient had an active infection that required systemic treatment",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "14 days before the first dose"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to understand or may not comply with test requirements",
            "criterions": [
                {
                    "exact_snippets": "Inability to understand",
                    "criterion": "understanding ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "may not comply with test requirements",
                    "criterion": "compliance with test requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis)",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease)",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allow the following diseases to enter the next stage of screening: type I diabetes",
                    "criterion": "type I diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allow the following diseases to enter the next stage of screening: ... skin diseases without systemic treatment (such as vitiligo, psoriasis)",
                    "criterion": "skin diseases without systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}