{
    "info": {
        "nct_id": "NCT05616494",
        "official_title": "A Single-arm, Multicenter, Phase Ⅱ Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer Who Have Received at Least One Line of Therapy",
        "inclusion_criteria": "1. Patients aged ≥18 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.\n2. Histologically or cytologically confirmed diagnosis of pancreatic cancer.\n3. Patients who have got disease progression or toxic intolerance after previous standard treatment (gemcitabine based and fluorouracil based therapy).\n4. At least one measurable lesion according to RECIST v1.1(the measurable lesion area had not received previous radiation therapy or had evidence of definite progression after the end of radiation therapy).\n5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n6. Patients with estimated survival time of ≥ 3 months.\n7. Patients with fine organ function (no medical supportive treatments such as blood component transfusion, growth factors within 2 weeks before taking the relevant inspections):\n\n   Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90 g/L; Albumin≥30 g/L; Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min; Total bilirubin≤1.5 × ULN(≤ 2 × ULN for patients with obstructive jaundice, ≤3 × ULN for patients with Gilbert's syndrome); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× ULN (≤5× ULN for patients with liver metastasis); Prothrombin time (PT) ≤ 1.5×ULN, International Normalized Ratio (INR) ≤ 1.5×ULN.\n8. The patient must agree to take adequate contraception from signing of ICF through 6 months after last dose, women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients who have a history of severe allergy to any excipients of the investigational drug or taxanes.\n2. Patients who had no response to previous taxanes treatments (no tumor shrinkage was observed or disease progressed within 3 months after initiation of the treatment).\n3. Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment.\n4. Patients who had a history of other active malignant tumors within 2 years before the first dose of the investigational drug, except for the study disease pancreatic cancer and curable cancer that had been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ that had been excised).\n5. Patients with brain metastases and meningeal metastases.\n6. Patients with chronic hepatitis B (HBsAg and/or HBcAb positive but HBV DNA < 2000 IU/mL can be included), chronic hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive.\n7. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for alopecia, hyperpigmentation, or other toxicity without safety risk judged by the investigator).\n8. Patients with a history of severe cardiovascular disease, including but not limited to:\n\n   1. Severe heart rhythm or conduction abnormalities, including but not limited to ventricular arrhythmia requiring clinical intervention and third degree atrioventricular block within 6 months before the first dose of the investigational drug;\n   2. History of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug;\n   3. Heart failure with New York Heart Association (NYHA) Classification of Class III and above;\n   4. Poorly controlled hypertension (Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening period).\n9. Patients with uncontrolled serous cavity effusion requiring frequent drainage or medical intervention (e.g., pleural effusion, abdominal effusion, pericardial effusion, etc., additional intervention was needed within 2 weeks after intervention, excluding exfoliative cytology testing of the exudate) within 7 days before the first dose of the investigational drug.\n10. Patients with severe or active infections (including tuberculous infections) that require systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of the investigational drug, antiviral therapy for patients with viral hepatitis is permitted.\n11. Patients who have received anti-tumor treatments such as chemotherapy, targeted therapy, immunotherapy and other clinical study drugs within 4 weeks or 5 half-lives of the drugs (whichever is shorter) before the first dose of the investigational drug.\n12. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug.\n13. Patients who have undergone major surgery within 4 weeks before the first dose of the investigational drug and had not recovered sufficiently, or who need to undergo elective surgery during the study.\n14. Pregnant or nursing women.\n15. Patients who is participating in another clinical study simultaneously unless it is an observational (non-interventional) clinical study or within the follow-up period of an interventional study.\n16. Other situations that the investigator considers not suitable for participating in the clinical study, including but not limited to: the patient is complicated by severe or uncontrolled medical conditions, which will increase the safety risk, interfere with the interpretation of study results or affect the study compliance.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients aged ≥18 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Patients aged ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily signed the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically or cytologically confirmed diagnosis of pancreatic cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis of pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who have got disease progression or toxic intolerance after previous standard treatment (gemcitabine based and fluorouracil based therapy).",
            "criterions": [
                {
                    "exact_snippets": "disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "toxic intolerance",
                    "criterion": "toxic intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous standard treatment (gemcitabine based and fluorouracil based therapy)",
                    "criterion": "previous standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gemcitabine based",
                                "fluorouracil based"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. At least one measurable lesion according to RECIST v1.1(the measurable lesion area had not received previous radiation therapy or had evidence of definite progression after the end of radiation therapy).",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion according to RECIST v1.1",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "the measurable lesion area had not received previous radiation therapy",
                    "criterion": "previous radiation therapy on measurable lesion area",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had evidence of definite progression after the end of radiation therapy",
                    "criterion": "progression after radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "definite progression"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2",
                    "criterion": "ECOG performance status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with estimated survival time of ≥ 3 months.",
            "criterions": [
                {
                    "exact_snippets": "estimated survival time of ≥ 3 months",
                    "criterion": "estimated survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with fine organ function (no medical supportive treatments such as blood component transfusion, growth factors within 2 weeks before taking the relevant inspections):",
            "criterions": [
                {
                    "exact_snippets": "fine organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "fine"
                        }
                    ]
                },
                {
                    "exact_snippets": "no medical supportive treatments such as blood component transfusion, growth factors within 2 weeks before taking the relevant inspections",
                    "criterion": "medical supportive treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥100×10^9/L; Hemoglobin ≥90 g/L; Albumin≥30 g/L; Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min; Total bilirubin≤1.5 × ULN(≤ 2 × ULN for patients with obstructive jaundice, ≤3 × ULN for patients with Gilbert's syndrome); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× ULN (≤5× ULN for patients with liver metastasis); Prothrombin time (PT) ≤ 1.5×ULN, International Normalized Ratio (INR) ≤ 1.5×ULN.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥1.5×10^9/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets ≥100×10^9/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥90 g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Albumin≥30 g/L",
                    "criterion": "albumin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min",
                    "criterion": "creatinine clearance rate",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin≤1.5 × ULN(≤ 2 × ULN for patients with obstructive jaundice, ≤3 × ULN for patients with Gilbert's syndrome)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× ULN (≤5× ULN for patients with liver metastasis)",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× ULN (≤5× ULN for patients with liver metastasis)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prothrombin time (PT) ≤ 1.5×ULN",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "International Normalized Ratio (INR) ≤ 1.5×ULN",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. The patient must agree to take adequate contraception from signing of ICF through 6 months after last dose, women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "The patient must agree to take adequate contraception from signing of ICF through 6 months after last dose",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug",
                    "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": "1. Patients who have a history of severe allergy to any excipients of the investigational drug or taxanes.",
            "criterions": [
                {
                    "exact_snippets": "history of severe allergy to any excipients of the investigational drug",
                    "criterion": "severe allergy to excipients of investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of severe allergy to ... taxanes",
                    "criterion": "severe allergy to taxanes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients who had no response to previous taxanes treatments (no tumor shrinkage was observed or disease progressed within 3 months after initiation of the treatment).",
            "criterions": [
                {
                    "exact_snippets": "no response to previous taxanes treatments",
                    "criterion": "response to previous taxanes treatments",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no tumor shrinkage was observed",
                    "criterion": "tumor shrinkage",
                    "requirements": [
                        {
                            "requirement_type": "observation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progressed within 3 months after initiation of the treatment",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment.",
            "criterions": [
                {
                    "exact_snippets": "partial or complete intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "partial",
                                "complete"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "complete biliary obstruction",
                    "criterion": "biliary obstruction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "complete"
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be relieved by active treatment",
                    "criterion": "relief by active treatment",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who had a history of other active malignant tumors within 2 years before the first dose of the investigational drug, except for the study disease pancreatic cancer and curable cancer that had been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ that had been excised).",
            "criterions": [
                {
                    "exact_snippets": "history of other active malignant tumors within 2 years before the first dose of the investigational drug",
                    "criterion": "history of other active malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for the study disease pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curable cancer that had been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ that had been excised)",
                    "criterion": "curable cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with brain metastases and meningeal metastases.",
            "criterions": [
                {
                    "exact_snippets": "Patients with brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meningeal metastases",
                    "criterion": "meningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with chronic hepatitis B (HBsAg and/or HBcAb positive but HBV DNA < 2000 IU/mL can be included), chronic hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive.",
            "criterions": [
                {
                    "exact_snippets": "chronic hepatitis B (HBsAg and/or HBcAb positive ... HBV DNA < 2000 IU/mL",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "HBsAg and/or HBcAb status",
                            "expected_value": [
                                "positive"
                            ]
                        },
                        {
                            "requirement_type": "HBV DNA level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2000,
                                "unit": "IU/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic hepatitis C (HCV antibody positive ... HCV RNA negative",
                    "criterion": "chronic hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "HCV antibody status",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "HCV RNA status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV antibody positive",
                    "criterion": "HIV antibody",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for alopecia, hyperpigmentation, or other toxicity without safety risk judged by the investigator).",
            "criterions": [
                {
                    "exact_snippets": "Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0",
                    "criterion": "adverse reactions from previous anti-tumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE 5.0 level"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hyperpigmentation",
                    "criterion": "hyperpigmentation",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other toxicity without safety risk judged by the investigator",
                    "criterion": "other toxicity",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with a history of severe cardiovascular disease, including but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "history of severe cardiovascular disease",
                    "criterion": "severe cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Severe heart rhythm or conduction abnormalities, including but not limited to ventricular arrhythmia requiring clinical intervention and third degree atrioventricular block within 6 months before the first dose of the investigational drug;",
            "criterions": [
                {
                    "exact_snippets": "Severe heart rhythm or conduction abnormalities",
                    "criterion": "heart rhythm or conduction abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmia requiring clinical intervention",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "clinical intervention",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "third degree atrioventricular block within 6 months before the first dose of the investigational drug",
                    "criterion": "third degree atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before the first dose of the investigational drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug;",
            "criterions": [
                {
                    "exact_snippets": "History of myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "angioplasty",
                    "criterion": "angioplasty",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "coronary artery bypass surgery",
                    "criterion": "coronary artery bypass surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Heart failure with New York Heart Association (NYHA) Classification of Class III and above;",
            "criterions": [
                {
                    "exact_snippets": "Heart failure with New York Heart Association (NYHA) Classification of Class III and above",
                    "criterion": "NYHA classification",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Poorly controlled hypertension (Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening period).",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled hypertension (Systolic blood pressure ≥ 160 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Poorly controlled hypertension ... diastolic blood pressure ≥ 100 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with uncontrolled serous cavity effusion requiring frequent drainage or medical intervention (e.g., pleural effusion, abdominal effusion, pericardial effusion, etc., additional intervention was needed within 2 weeks after intervention, excluding exfoliative cytology testing of the exudate) within 7 days before the first dose of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled serous cavity effusion requiring frequent drainage or medical intervention",
                    "criterion": "uncontrolled serous cavity effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "intervention",
                            "expected_value": "frequent drainage or medical intervention"
                        }
                    ]
                },
                {
                    "exact_snippets": "additional intervention was needed within 2 weeks after intervention",
                    "criterion": "additional intervention",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 2 weeks after intervention"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days before the first dose of the investigational drug",
                    "criterion": "timing before first dose",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days before the first dose of the investigational drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with severe or active infections (including tuberculous infections) that require systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of the investigational drug, antiviral therapy for patients with viral hepatitis is permitted.",
            "criterions": [
                {
                    "exact_snippets": "severe or active infections",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "tuberculous infections",
                    "criterion": "tuberculous infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "require systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of the investigational drug",
                    "criterion": "systemic antibacterial, antifungal, or antiviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "antiviral therapy for patients with viral hepatitis is permitted",
                    "criterion": "antiviral therapy for viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients who have received anti-tumor treatments such as chemotherapy, targeted therapy, immunotherapy and other clinical study drugs within 4 weeks or 5 half-lives of the drugs (whichever is shorter) before the first dose of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received anti-tumor treatments such as chemotherapy, targeted therapy, immunotherapy and other clinical study drugs",
                    "criterion": "prior anti-tumor treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks or 5 half-lives of the drugs (whichever is shorter) before the first dose of the investigational drug",
                    "criterion": "time since last anti-tumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug.",
                    "criterion": "use of potent inhibitors or inducers of CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks before the first dose of the investigational drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients who have undergone major surgery within 4 weeks before the first dose of the investigational drug and had not recovered sufficiently, or who need to undergo elective surgery during the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have undergone major surgery within 4 weeks before the first dose of the investigational drug",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "had not recovered sufficiently",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "who need to undergo elective surgery during the study",
                    "criterion": "elective surgery",
                    "requirements": [
                        {
                            "requirement_type": "need for surgery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Pregnant or nursing women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing women",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients who is participating in another clinical study simultaneously unless it is an observational (non-interventional) clinical study or within the follow-up period of an interventional study.",
            "criterions": [
                {
                    "exact_snippets": "Patients who is participating in another clinical study simultaneously",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless it is an observational (non-interventional) clinical study",
                    "criterion": "participation in observational clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the follow-up period of an interventional study",
                    "criterion": "within follow-up period of interventional study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Other situations that the investigator considers not suitable for participating in the clinical study, including but not limited to: the patient is complicated by severe or uncontrolled medical conditions, which will increase the safety risk, interfere with the interpretation of study results or affect the study compliance.",
            "criterions": [
                {
                    "exact_snippets": "the patient is complicated by severe or uncontrolled medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "increase the safety risk",
                    "criterion": "safety risk",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "interfere with the interpretation of study results",
                    "criterion": "interpretation of study results",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "affect the study compliance",
                    "criterion": "study compliance",
                    "requirements": [
                        {
                            "requirement_type": "affect",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}