{
    "info": {
        "nct_id": "NCT05236582",
        "official_title": "Herombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors",
        "inclusion_criteria": "* Aged ≥18 years old, male or female;\n* Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；\n* Stop radiotherapy or chemotherapy for more than 1 month;\n* Platelet counts <30 ×10^9/L, and bleeding tendency;\n* Estimated survival period ≥ 6 months；\n* People who are willing to sign the informed consent voluntarily and follow the research program.\n* Liver and kidney function<1.5×upper limit of normal, qualified for physical examination；\n* Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；\n* Patients with poor compliance;\n* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.\n* There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past；\n* Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；\n* Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；\n* Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；\n* Patients with sepsis or patients with other irregular bleeding；\n* Patients taking antiplatelet drugs at the same time；\n* Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients；\n* Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block;\n* Researchers believe that patients should not participate in the test of any other condition.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Aged ≥18 years old, male or female;",
            "criterions": [
                {
                    "exact_snippets": "Aged ≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed genders",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；",
            "criterions": [
                {
                    "exact_snippets": "Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT)",
                    "criterion": "chemotherapy-induced thrombocytopenia (CIT)",
                    "requirements": [
                        {
                            "requirement_type": "diagnostic criteria",
                            "expected_value": "conform"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ineffective after repeated treatment with rhTPO or IL-11",
                    "criterion": "treatment with rhTPO or IL-11",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "ineffective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stop radiotherapy or chemotherapy for more than 1 month;",
            "criterions": [
                {
                    "exact_snippets": "Stop radiotherapy ... for more than 1 month",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "cessation duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Stop ... chemotherapy for more than 1 month",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "cessation duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet counts <30 ×10^9/L, and bleeding tendency;",
            "criterions": [
                {
                    "exact_snippets": "Platelet counts <30 ×10^9/L",
                    "criterion": "platelet counts",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding tendency",
                    "criterion": "bleeding tendency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated survival period ≥ 6 months；",
            "criterions": [
                {
                    "exact_snippets": "Estimated survival period ≥ 6 months",
                    "criterion": "survival period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* People who are willing to sign the informed consent voluntarily and follow the research program.",
            "criterions": [
                {
                    "exact_snippets": "willing to sign the informed consent voluntarily",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow the research program",
                    "criterion": "research program adherence",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Liver and kidney function<1.5×upper limit of normal, qualified for physical examination；",
            "criterions": [
                {
                    "exact_snippets": "Liver ... <1.5×upper limit of normal",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "function level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "× upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "kidney function<1.5×upper limit of normal",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "function level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "× upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "qualified for physical examination",
                    "criterion": "physical examination",
                    "requirements": [
                        {
                            "requirement_type": "qualification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;",
            "criterions": [
                {
                    "exact_snippets": "Subject is practicing an acceptable method of contraception",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential must have a negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；",
            "criterions": [
                {
                    "exact_snippets": "uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors",
                    "criterion": "extensive metastasis of malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable primary diseases of important organs, such as ... liver failure",
                    "criterion": "liver failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable primary diseases of important organs, such as ... heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable primary diseases of important organs, such as ... kidney failure",
                    "criterion": "kidney failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with poor compliance;",
            "criterions": [
                {
                    "exact_snippets": "Patients with poor compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;",
            "criterions": [
                {
                    "exact_snippets": "Positive serology for HIV",
                    "criterion": "HIV serology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive serology for ... hepatitis B virus (HBV)",
                    "criterion": "hepatitis B virus (HBV) serology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive serology for ... hepatitis C virus (HCV)",
                    "criterion": "hepatitis C virus (HCV) serology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive serology for ... hepatitis D virus (HDV)",
                    "criterion": "hepatitis D virus (HDV) serology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive serology for ... Syphilis",
                    "criterion": "Syphilis serology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive for Epstein-Barr Virus DNA",
                    "criterion": "Epstein-Barr Virus DNA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive for ... Cytomegalovirus DNA",
                    "criterion": "Cytomegalovirus DNA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.",
            "criterions": [
                {
                    "exact_snippets": "extensive and severe bleeding",
                    "criterion": "bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "extensive and severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoptysis",
                    "criterion": "hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "upper gastrointestinal bleeding",
                    "criterion": "upper gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intracranial hemorrhage",
                    "criterion": "intracranial hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；",
            "criterions": [
                {
                    "exact_snippets": "heart disease requiring treatment",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；",
            "criterions": [
                {
                    "exact_snippets": "thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis",
                    "criterion": "thrombotic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thrombosis",
                    "criterion": "thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "atherosclerosis",
                    "criterion": "atherosclerosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Those who have received allogeneic stem cell transplantation or organ transplantation in the past；",
            "criterions": [
                {
                    "exact_snippets": "received allogeneic stem cell transplantation",
                    "criterion": "allogeneic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received ... organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；",
            "criterions": [
                {
                    "exact_snippets": "mental disorders",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot normally obtain informed consent",
                    "criterion": "ability to obtain informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "undergo trials and follow-up",
                    "criterion": "ability to undergo trials and follow-up",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；",
            "criterions": [
                {
                    "exact_snippets": "toxic symptoms caused by treatment before participating in the trial have not disappeared",
                    "criterion": "toxic symptoms from prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；",
            "criterions": [
                {
                    "exact_snippets": "diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe heart failure",
                    "criterion": "severe heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial obstruction",
                    "criterion": "myocardial obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable arrhythmia",
                    "criterion": "unstable arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina in the past 6 months",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric ulcers",
                    "criterion": "gastric ulcers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mobility Autoimmune diseases",
                    "criterion": "mobility autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with sepsis or patients with other irregular bleeding；",
            "criterions": [
                {
                    "exact_snippets": "Patients with sepsis",
                    "criterion": "sepsis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with other irregular bleeding",
                    "criterion": "irregular bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients taking antiplatelet drugs at the same time；",
            "criterions": [
                {
                    "exact_snippets": "Patients taking antiplatelet drugs",
                    "criterion": "antiplatelet drug use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients；",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening)",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "suspected"
                        },
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding patients",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "breastfeeding"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block;",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing cardiac disease",
                    "criterion": "pre-existing cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure of New York Heart Association [NYHA] Grade III/IV",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "arrhythmia requiring treatment",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation)",
                    "criterion": "arrhythmia increasing thrombotic risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "QT >450msec",
                    "criterion": "QT interval",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc > 480 for patients with a Bundle Branch Block",
                    "criterion": "QTc interval with Bundle Branch Block",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Researchers believe that patients should not participate in the test of any other condition.",
            "criterions": [
                {
                    "exact_snippets": "patients should not participate in the test of any other condition",
                    "criterion": "participation in other condition tests",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}