{
    "info": {
        "nct_id": "NCT03274882",
        "official_title": "Open-label Multicentre Confirmatory Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapies",
        "inclusion_criteria": "* Male or female aged ≥18 years of age\n* Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum\n* Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients (if RAS mutation status was evaluated)) and was refractory or intolerant to those chemotherapies\n* Has Eastern Cooperative Group (ECOG) performance status of 0 or 1\n* Has at least one measurable metastatic lesion(s)\n* Has adequate organ function\n* Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnancy, breastfeeding\n* Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed\n* Has previously received S95005 or history of allergic reaction attributed to compounds of similar composition to S95005\n* Has a serious illness or medical condition(s) as described in the protocol\n* Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion\n* Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female aged ≥18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum",
            "criterions": [
                {
                    "exact_snippets": "definitive histologically or cytologically confirmed adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the colon or rectum",
                    "criterion": "location of adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "colon",
                                "rectum"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients (if RAS mutation status was evaluated)) and was refractory or intolerant to those chemotherapies",
            "criterions": [
                {
                    "exact_snippets": "Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer",
                    "criterion": "prior regimens of standard chemotherapies",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including fluoropyrimidines, irinotecan and oxaliplatin",
                    "criterion": "types of chemotherapies received",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "fluoropyrimidines",
                                "irinotecan",
                                "oxaliplatin"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "if accessible, an anti-VEGF monoclonal antibody",
                    "criterion": "anti-VEGF monoclonal antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients",
                    "criterion": "anti-EGFR monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if RAS mutation status was evaluated",
                    "criterion": "RAS mutation status evaluation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "was refractory or intolerant to those chemotherapies",
                    "criterion": "refractory or intolerant to chemotherapies",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "refractory or intolerant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has Eastern Cooperative Group (ECOG) performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Has Eastern Cooperative Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has at least one measurable metastatic lesion(s)",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable metastatic lesion(s)",
                    "criterion": "metastatic lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication",
            "criterions": [
                {
                    "exact_snippets": "Female participants of childbearing potential",
                    "criterion": "female participants",
                    "requirements": [
                        {
                            "requirement_type": "childbearing potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male participants with partners of childbearing potential",
                    "criterion": "male participants",
                    "requirements": [
                        {
                            "requirement_type": "partner's childbearing potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication",
                    "criterion": "birth control",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": "highly effective method during the study and for 6 months after discontinuation"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Pregnancy, breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed",
            "criterions": [
                {
                    "exact_snippets": "Participation in another interventional study within 4 weeks prior to inclusion",
                    "criterion": "participation in another interventional study",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participation in non-interventional registries or epidemiological studies is allowed",
                    "criterion": "participation in non-interventional registries or epidemiological studies",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has previously received S95005 or history of allergic reaction attributed to compounds of similar composition to S95005",
            "criterions": [
                {
                    "exact_snippets": "Has previously received S95005",
                    "criterion": "previous treatment with S95005",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of allergic reaction attributed to compounds of similar composition to S95005",
                    "criterion": "allergic reaction to compounds similar to S95005",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a serious illness or medical condition(s) as described in the protocol",
            "criterions": [
                {
                    "exact_snippets": "Has a serious illness or medical condition(s)",
                    "criterion": "serious illness or medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion",
            "criterions": [
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. major surgery",
                    "criterion": "recent major surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. ... field radiation",
                    "criterion": "recent field radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. ... anticancer therapy",
                    "criterion": "recent anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxicity ... greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2",
                    "criterion": "unresolved toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "attributed to any prior therapies",
                    "criterion": "attribution to prior therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}