{
    "info": {
        "nct_id": "NCT05298020",
        "official_title": "A Single-arm Phase II Study of Envafolimab Combined With Endostar and Nab-paclitaxel Plus Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer",
        "inclusion_criteria": "* Pathologically proven pancreatic cancer ；\n* Age ≥ 18 years old, gender is not limited ； Expected survival ≥ 3 months ； ECOG 0-1； At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）； No previous chemotherapy, radiotherapy, immunotherapy, targeted therapy； The function of major organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements：（Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days);Neutrophil count > 1.5×109/L; Platelet count ≥ 100×109/L;Total bilirubin ≤ 1.5×ULN (upper limit of normal);Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤2.5×ULN; if liver metastases, ALT or AST ≤ 5×ULN;Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);Cardiac Doppler Ultrasound Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 50% ）；\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with other malignant tumors in the past or at the same time, and those tumors that are judged by the investigator to not affect the patient's life in the short term can be excluded； Participated in clinical trials of other drugs within four weeks ； Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; Patients with a history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requires Long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Urine routine indicates urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g; For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: should be surgically sterilized, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Have used immune targeted therapy drugs; Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need corticosteroids; History of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, history of chronic diarrheal diseases such as irritable bowel syndrome; history of sarcoidosis Medical history or history of tuberculosis; history of active hepatitis B, hepatitis C and HIV infection; Patients with allergic reactions to human or camel-derived monoclonal antibodies; Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; Pleural effusion or ascites with clinical symptoms requiring clinical intervention; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Pathologically proven pancreatic cancer ；",
            "criterions": [
                {
                    "exact_snippets": "Pathologically proven pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "pathologically proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years old, gender is not limited ； Expected survival ≥ 3 months ； ECOG 0-1； At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）； No previous chemotherapy, radiotherapy, immunotherapy, targeted therapy； The function of major organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements：（Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days);Neutrophil count > 1.5×109/L; Platelet count ≥ 100×109/L;Total bilirubin ≤ 1.5×ULN (upper limit of normal);Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤2.5×ULN; if liver metastases, ALT or AST ≤ 5×ULN;Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);Cardiac Doppler Ultrasound Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 50% ）；",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "gender is not limited",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "restriction",
                            "expected_value": "not limited"
                        }
                    ]
                },
                {
                    "exact_snippets": "Expected survival ≥ 3 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）",
                    "criterion": "measurable tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "spiral CT examination"
                        },
                        {
                            "requirement_type": "maximum diameter",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous chemotherapy, radiotherapy, immunotherapy, targeted therapy",
                    "criterion": "previous treatments",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": [
                                "chemotherapy",
                                "radiotherapy",
                                "immunotherapy",
                                "targeted therapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "The function of major organs is good",
                    "criterion": "major organ function",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days)",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        },
                        {
                            "requirement_type": "blood transfusion",
                            "expected_value": "no blood transfusion within 14 days"
                        }
                    ]
                },
                {
                    "exact_snippets": "Neutrophil count > 1.5×109/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥ 100×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5×ULN (upper limit of normal)",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤2.5×ULN; if liver metastases, ALT or AST ≤ 5×ULN",
                    "criterion": "ALT or AST levels",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "×ULN"
                            }
                        },
                        {
                            "requirement_type": "condition with liver metastases",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula)",
                    "criterion": "endogenous creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiac Doppler Ultrasound Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients with other malignant tumors in the past or at the same time, and those tumors that are judged by the investigator to not affect the patient's life in the short term can be excluded； Participated in clinical trials of other drugs within four weeks ； Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; Patients with a history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requires Long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Urine routine indicates urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g; For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: should be surgically sterilized, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Have used immune targeted therapy drugs; Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need corticosteroids; History of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, history of chronic diarrheal diseases such as irritable bowel syndrome; history of sarcoidosis Medical history or history of tuberculosis; history of active hepatitis B, hepatitis C and HIV infection; Patients with allergic reactions to human or camel-derived monoclonal antibodies; Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; Pleural effusion or ascites with clinical symptoms requiring clinical intervention; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study;",
            "criterions": [
                {
                    "exact_snippets": "Patients with other malignant tumors in the past or at the same time",
                    "criterion": "other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participated in clinical trials of other drugs within four weeks",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with known CNS metastases or a history of CNS metastases prior to screening",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "exclusion by CT or MRI",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a history of unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "newly diagnosed angina pectoris within 3 months before screening",
                    "criterion": "newly diagnosed angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction events within 6 months before screening",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requires Long-term use of antiarrhythmic drugs",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "QTcF",
                            "expected_value": {
                                "operator": "<",
                                "value": 450,
                                "unit": "ms"
                            }
                        },
                        {
                            "requirement_type": "QTcF",
                            "expected_value": {
                                "operator": "<",
                                "value": 470,
                                "unit": "ms"
                            }
                        },
                        {
                            "requirement_type": "long-term use of antiarrhythmic drugs",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association class ≥ II cardiac insufficiency",
                    "criterion": "New York Heart Association class",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Urine routine indicates urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g",
                    "criterion": "urine protein",
                    "requirements": [
                        {
                            "requirement_type": "routine test",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "+"
                            }
                        },
                        {
                            "requirement_type": "24-hour quantification",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "g"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period",
                    "criterion": "female contraception",
                    "requirements": [
                        {
                            "requirement_type": "surgical sterilization",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "postmenopausal",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "use of contraceptive",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum or urine pregnancy test must be negative within 7 days and must be non-nursing",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Male subjects: should be surgically sterilized, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period",
                    "criterion": "male contraception",
                    "requirements": [
                        {
                            "requirement_type": "surgical sterilization",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "use of contraceptive",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Have used immune targeted therapy drugs",
                    "criterion": "use of immune targeted therapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need corticosteroids",
                    "criterion": "pneumonia requiring corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "History of chronic autoimmune diseases, such as systemic lupus erythematosus",
                    "criterion": "chronic autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of inflammatory bowel disease such as ulcerative colitis, Crohn's disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of chronic diarrheal diseases such as irritable bowel syndrome",
                    "criterion": "chronic diarrheal diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of sarcoidosis",
                    "criterion": "sarcoidosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical history or history of tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of active hepatitis B, hepatitis C and HIV infection",
                    "criterion": "active hepatitis B, hepatitis C and HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with allergic reactions to human or camel-derived monoclonal antibodies",
                    "criterion": "allergic reactions to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders",
                    "criterion": "psychotropic substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Pleural effusion or ascites with clinical symptoms requiring clinical intervention",
                    "criterion": "pleural effusion or ascites",
                    "requirements": [
                        {
                            "requirement_type": "clinical intervention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study",
                    "criterion": "concomitant diseases",
                    "requirements": [
                        {
                            "requirement_type": "impact on safety or study completion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}