{
    "info": {
        "nct_id": "NCT04060472",
        "official_title": "Single-center, Single-arm and Phase II/III Clinical Study of Paclitaxel (Albumin-binding) Combined With Oxaliplatin as First-line Treatment for Advanced Hepatobiliary and Malignant Tumors",
        "inclusion_criteria": "* 1) Patients are ≥ 18 years old; 2) Pathological diagnosis confirmed advanced hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, extrahepatic cholangiocellular carcinoma, gallbladder carcinoma and pancreatic cancer by histopathological examination; 3) Having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria; 4) Estimated survival time > 3 months; 5) There are no other concurrent anti-cancer treatments (including local radiotherapy and molecular targeted therapy, etc.) or previous treatment history; 6) ECOG PS score ≤ 2 points; 7) Cardiac color Doppler examination indicates a left ventricular ejection fraction (LVEF) ≥ 50%; 8) Having no obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment; 9) Liver function test: total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤ 2.5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance ≥50ml/min; 10) Patients can understand and sign the informed consent form.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* 1) Pregnant or lactating female patients (women of childbearing age must be confirmed to have negative pregnancy test results within 7 days prior to the first dose, if they are positive, ultrasound examination is required to be performed to exclude pregnancy); women of childbearing age refuse to receive contraception.\n\n  2) Having other malignant tumors, except cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ carcinoma in any other regions; 3) Having abnormal bone marrow hyperplasia and other hematopoietic disorders; 4) Having active infections, HIV infection, and viral hepatitis that require systemic treatment; 5) Child-Pugh score > 7 points; 6) Being combined with medium-large ascites or hepatic encephalopathy; 7) Subjects with ≥1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Response Standard (NCI-CTC) version 5.0; 8)Patients with severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs intervention; 9) Being allergic to the drug or drug ingredients used in this test or having hypersensitivity history; 10) Having received any other drug treatment or participated in another interventional clinical trial within 30 days of the screening period; 11) Having dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire; 12) Being considered to be unsuitable for enrollment by investigators.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1) Patients are ≥ 18 years old; 2) Pathological diagnosis confirmed advanced hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, extrahepatic cholangiocellular carcinoma, gallbladder carcinoma and pancreatic cancer by histopathological examination; 3) Having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria; 4) Estimated survival time > 3 months; 5) There are no other concurrent anti-cancer treatments (including local radiotherapy and molecular targeted therapy, etc.) or previous treatment history; 6) ECOG PS score ≤ 2 points; 7) Cardiac color Doppler examination indicates a left ventricular ejection fraction (LVEF) ≥ 50%; 8) Having no obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment; 9) Liver function test: total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤ 2.5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance ≥50ml/min; 10) Patients can understand and sign the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Patients are ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Pathological diagnosis confirmed advanced hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, extrahepatic cholangiocellular carcinoma, gallbladder carcinoma and pancreatic cancer by histopathological examination",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "advanced hepatocellular carcinoma",
                                "intrahepatic cholangiocellular carcinoma",
                                "extrahepatic cholangiocellular carcinoma",
                                "gallbladder carcinoma",
                                "pancreatic cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Estimated survival time > 3 months",
                    "criterion": "estimated survival time",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "There are no other concurrent anti-cancer treatments (including local radiotherapy and molecular targeted therapy, etc.) or previous treatment history",
                    "criterion": "concurrent anti-cancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG PS score ≤ 2 points",
                    "criterion": "ECOG PS score",
                    "requirements": [
                        {
                            "requirement_type": "maximum score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "points"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiac color Doppler examination indicates a left ventricular ejection fraction (LVEF) ≥ 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "minimum percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Having no obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment",
                    "criterion": "hematological health",
                    "requirements": [
                        {
                            "requirement_type": "ANC",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        },
                        {
                            "requirement_type": "platelet count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        },
                        {
                            "requirement_type": "hemoglobin (Hb)",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        },
                        {
                            "requirement_type": "white blood cell count (WBC)",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "×10^9/L"
                            }
                        },
                        {
                            "requirement_type": "bleeding tendency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver function test: total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤ 2.5 times the upper limit of normal value",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "total bilirubin (TBIL)",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal"
                            }
                        },
                        {
                            "requirement_type": "alanine aminotransferase (ALT)",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        },
                        {
                            "requirement_type": "aspartate aminotransferase (AST)",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance ≥50ml/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "serum creatinine (Cr)",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        },
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients can understand and sign the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability to understand and sign",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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) Pregnant or lactating female patients (women of childbearing age must be confirmed to have negative pregnancy test results within 7 days prior to the first dose, if they are positive, ultrasound examination is required to be performed to exclude pregnancy); women of childbearing age refuse to receive contraception.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or lactating female patients",
                    "criterion": "pregnancy or lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing age must be confirmed to have negative pregnancy test results within 7 days prior to the first dose",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing age refuse to receive contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2) Having other malignant tumors, except cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ carcinoma in any other regions; 3) Having abnormal bone marrow hyperplasia and other hematopoietic disorders; 4) Having active infections, HIV infection, and viral hepatitis that require systemic treatment; 5) Child-Pugh score > 7 points; 6) Being combined with medium-large ascites or hepatic encephalopathy; 7) Subjects with ≥1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Response Standard (NCI-CTC) version 5.0; 8)Patients with severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs intervention; 9) Being allergic to the drug or drug ingredients used in this test or having hypersensitivity history; 10) Having received any other drug treatment or participated in another interventional clinical trial within 30 days of the screening period; 11) Having dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire; 12) Being considered to be unsuitable for enrollment by investigators.",
            "criterions": [
                {
                    "exact_snippets": "Having other malignant tumors",
                    "criterion": "other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal bone marrow hyperplasia",
                    "criterion": "abnormal bone marrow hyperplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other hematopoietic disorders",
                    "criterion": "hematopoietic disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "viral hepatitis that require systemic treatment",
                    "criterion": "viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "systemic treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Child-Pugh score > 7 points",
                    "criterion": "Child-Pugh score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "points"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "medium-large ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "medium-large"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatic encephalopathy",
                    "criterion": "hepatic encephalopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Response Standard (NCI-CTC) version 5.0",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "NCI-CTC version 5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months",
                    "criterion": "cerebrovascular accidents",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypertension that cannot be controlled after drug intervention",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control after drug intervention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure (NYHA 2-4)",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA class",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NYHA"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "arrhythmia requiring drugs intervention",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "drugs intervention"
                        }
                    ]
                },
                {
                    "exact_snippets": "Being allergic to the drug or drug ingredients used in this test",
                    "criterion": "allergy to the drug or drug ingredients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity history",
                    "criterion": "hypersensitivity history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Having received any other drug treatment or participated in another interventional clinical trial within 30 days of the screening period",
                    "criterion": "participation in another interventional clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Having dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mental state changes",
                    "criterion": "mental state changes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any mental illness that may interfere with understanding or making informed consent or completing a questionnaire",
                    "criterion": "mental illness",
                    "requirements": [
                        {
                            "requirement_type": "interference with understanding or making informed consent or completing a questionnaire",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Being considered to be unsuitable for enrollment by investigators",
                    "criterion": "suitability for enrollment",
                    "requirements": [
                        {
                            "requirement_type": "investigator's judgment",
                            "expected_value": "unsuitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}