{
    "info": {
        "nct_id": "NCT02068131",
        "official_title": "Phase II Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Plus Capatabine in Treating Patients With Metastatic Colorectal Cancer After Failure of Standard Treatment",
        "inclusion_criteria": "* Aged above 18 years.\n* Pathologically confirmed metastatic adenocarcinoma of the colon or rectum. All other histological types are excluded.\n* Failure of Second-Line and more than second-line treatment, and fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens.(Subjects who progress during or within 3 months following the last administration of approved standard therapies and terminate standard treatment due to unacceptable toxicity warranting.).If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment.Subject received last-line treatment not including capecitabine.\n* At least one measurable lesion according to the RECIST criteria that has not been previously local treated. Minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral CT or NMR.Malignant lymph nodes short diameter as follows: greater than or equal to 15 mm measured by spiral CT.\n* ECOG performance status 0, 1 or 2.\n* Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).\n* Life expectancy of at least 3 months.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment with novaferon.\n* Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.\n* Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.\n* Patient who were allergic to Interferon-α or who had interferon-α antibody.\n* Patients with uncontrolled central nervous system (CNS) metastases.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Aged above 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Aged above 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathologically confirmed metastatic adenocarcinoma of the colon or rectum. All other histological types are excluded.",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed metastatic adenocarcinoma of the colon or rectum.",
                    "criterion": "metastatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically"
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "colon",
                                "rectum"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "All other histological types are excluded.",
                    "criterion": "histological type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "all other types"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failure of Second-Line and more than second-line treatment, and fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens.(Subjects who progress during or within 3 months following the last administration of approved standard therapies and terminate standard treatment due to unacceptable toxicity warranting.).If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment.Subject received last-line treatment not including capecitabine.",
            "criterions": [
                {
                    "exact_snippets": "Failure of Second-Line and more than second-line treatment",
                    "criterion": "treatment failure",
                    "requirements": [
                        {
                            "requirement_type": "treatment line",
                            "expected_value": ">= second-line"
                        }
                    ]
                },
                {
                    "exact_snippets": "fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens",
                    "criterion": "treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "fluoropyrimidine",
                                "irinotecan",
                                "oxaliplatin"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who progress during or within 3 months following the last administration of approved standard therapies",
                    "criterion": "progression timing",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "during or within 3 months following last administration of approved standard therapies"
                        }
                    ]
                },
                {
                    "exact_snippets": "terminate standard treatment due to unacceptable toxicity",
                    "criterion": "treatment termination",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": "unacceptable toxicity"
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy",
                    "criterion": "recurrence and metastasis timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 6 months after discontinuation of adjuvant chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant chemotherapy is considered to be first-line treatment",
                    "criterion": "adjuvant chemotherapy classification",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "first-line treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject received last-line treatment not including capecitabine",
                    "criterion": "last-line treatment",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "capecitabine"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one measurable lesion according to the RECIST criteria that has not been previously local treated. Minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral CT or NMR.Malignant lymph nodes short diameter as follows: greater than or equal to 15 mm measured by spiral CT.",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion according to the RECIST criteria",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion ... that has not been previously local treated",
                    "criterion": "local treatment of lesion",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Minimum indicator lesion size ... greater than or equal to 10 mm measured by spiral CT or NMR",
                    "criterion": "indicator lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Malignant lymph nodes short diameter ... greater than or equal to 15 mm measured by spiral CT",
                    "criterion": "malignant lymph nodes short diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0, 1 or 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0, 1 or 2.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).",
            "criterions": [
                {
                    "exact_snippets": "Minimum of 4 weeks since any local radiotherapy or surgery",
                    "criterion": "time since local radiotherapy or surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately recovered from toxicities of any prior therapy",
                    "criterion": "recovery from toxicities of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior treatment with novaferon.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with novaferon.",
                    "criterion": "novaferon treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women who may be pregnant",
                    "criterion": "potential pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "positive drug test before administration",
                    "criterion": "drug test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.",
            "criterions": [
                {
                    "exact_snippets": "Patient of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 1 year postmenopausal women",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "reluctant to take contraceptive measures",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who were allergic to Interferon-α or who had interferon-α antibody.",
            "criterions": [
                {
                    "exact_snippets": "allergic to Interferon-α",
                    "criterion": "allergy to Interferon-α",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "interferon-α antibody",
                    "criterion": "interferon-α antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled central nervous system (CNS) metastases.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}