{
    "info": {
        "nct_id": "NCT06435260",
        "official_title": "To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer",
        "inclusion_criteria": "1. Age:18 to 75 years old, male or female;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n3. Tumor was located in the pancreas;\n4. Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;\n5. No distant metastasis;\n6. The pancreatic tumor is located more than 1cm away from the duodenum；\n7. Clinical assessment was locally advanced or critical for resectable.\n\nLocally advanced pancreatic cancer diagnostic criteria: (1) due to tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum, cannot safely - superior mesenteric vein reconstruction. ② (pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or celiac artery > 180°. Tumor contact with superior mesenteric artery or coeliac trunk artery > 180°, tumor contact with coeliac trunk artery and invasion of abdominal aorta.\n\nCritical for resectable pancreatic cancer diagnostic criteria: (1) contact with portal vein tumor - superior mesenteric vein > 180 °, 180 ° or less or contact combined intravenous contour irregular or venous thrombosis, but safety is complete resection and reconstruction; The tumor contacted the inferior vena cava. ② (pancreatic head/uncinate process tumors) the tumors contacting the common hepatic artery, but not involving the celiac artery or the origin of the left and right hepatic arteries, can be completely resected and safely reconstructed; Superior mesenteric artery tumor contact 180 ° or less; The tumor contacts the aberrant arteries (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, etc.). (pancreatic body and tail tumors) tumor contact with superior mesenteric artery ≤180°; Tumor contact with celiac artery ≤180°; 7.There was no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above.\n\nParticipants were willing to join in this study, good adherence and written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Patients who did not meet these inclusion criteria;\n2. Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;\n3. The investigators think inappropriate.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age:18 to 75 years old, male or female;",
            "criterions": [
                {
                    "exact_snippets": "Age:18 to 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 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"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Tumor was located in the pancreas;",
            "criterions": [
                {
                    "exact_snippets": "Tumor was located in the pancreas",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "pancreas"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;",
            "criterions": [
                {
                    "exact_snippets": "Pathological diagnosis was pancreatic ductal adenocarcinoma",
                    "criterion": "pathological diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "pancreatic ductal adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Pathological diagnosis was ... acinar cell carcinoma",
                    "criterion": "pathological diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "acinar cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. No distant metastasis;",
            "criterions": [
                {
                    "exact_snippets": "No distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. The pancreatic tumor is located more than 1cm away from the duodenum；",
            "criterions": [
                {
                    "exact_snippets": "The pancreatic tumor is located more than 1cm away from the duodenum",
                    "criterion": "pancreatic tumor location",
                    "requirements": [
                        {
                            "requirement_type": "distance from duodenum",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Clinical assessment was locally advanced or critical for resectable.",
            "criterions": [
                {
                    "exact_snippets": "Clinical assessment was locally advanced",
                    "criterion": "clinical assessment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical assessment was ... critical for resectable",
                    "criterion": "clinical assessment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "critical for resectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Locally advanced pancreatic cancer diagnostic criteria: (1) due to tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum, cannot safely - superior mesenteric vein reconstruction. ② (pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or celiac artery > 180°. Tumor contact with superior mesenteric artery or coeliac trunk artery > 180°, tumor contact with coeliac trunk artery and invasion of abdominal aorta.",
            "criterions": [
                {
                    "exact_snippets": "tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum",
                    "criterion": "tumor invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum",
                    "criterion": "venous occlusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum",
                    "criterion": "involvement of superior mesenteric vein branch of jejunum",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "wide range"
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot safely - superior mesenteric vein reconstruction",
                    "criterion": "superior mesenteric vein reconstruction",
                    "requirements": [
                        {
                            "requirement_type": "safety",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "(pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or celiac artery > 180°",
                    "criterion": "tumor contact with superior mesenteric artery",
                    "requirements": [
                        {
                            "requirement_type": "angle",
                            "expected_value": {
                                "operator": ">",
                                "value": 180,
                                "unit": "°"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "(pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or celiac artery > 180°",
                    "criterion": "tumor contact with celiac artery",
                    "requirements": [
                        {
                            "requirement_type": "angle",
                            "expected_value": {
                                "operator": ">",
                                "value": 180,
                                "unit": "°"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor contact with superior mesenteric artery or coeliac trunk artery > 180°",
                    "criterion": "tumor contact with coeliac trunk artery",
                    "requirements": [
                        {
                            "requirement_type": "angle",
                            "expected_value": {
                                "operator": ">",
                                "value": 180,
                                "unit": "°"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor contact with coeliac trunk artery and invasion of abdominal aorta",
                    "criterion": "invasion of abdominal aorta",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Critical for resectable pancreatic cancer diagnostic criteria: (1) contact with portal vein tumor - superior mesenteric vein > 180 °, 180 ° or less or contact combined intravenous contour irregular or venous thrombosis, but safety is complete resection and reconstruction; The tumor contacted the inferior vena cava. ② (pancreatic head/uncinate process tumors) the tumors contacting the common hepatic artery, but not involving the celiac artery or the origin of the left and right hepatic arteries, can be completely resected and safely reconstructed; Superior mesenteric artery tumor contact 180 ° or less; The tumor contacts the aberrant arteries (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, etc.). (pancreatic body and tail tumors) tumor contact with superior mesenteric artery ≤180°; Tumor contact with celiac artery ≤180°; 7.There was no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above.",
            "criterions": [
                {
                    "exact_snippets": "contact with portal vein tumor - superior mesenteric vein > 180 °, 180 ° or less or contact combined intravenous contour irregular or venous thrombosis",
                    "criterion": "portal vein tumor contact",
                    "requirements": [
                        {
                            "requirement_type": "angle",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 180,
                                        "unit": "°"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "angle",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 180,
                                        "unit": "°"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "intravenous contour irregular"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "venous thrombosis"
                        }
                    ]
                },
                {
                    "exact_snippets": "The tumor contacted the inferior vena cava",
                    "criterion": "inferior vena cava tumor contact",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(pancreatic head/uncinate process tumors) the tumors contacting the common hepatic artery, but not involving the celiac artery or the origin of the left and right hepatic arteries",
                    "criterion": "common hepatic artery tumor contact",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "celiac artery"
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "origin of the left and right hepatic arteries"
                        }
                    ]
                },
                {
                    "exact_snippets": "Superior mesenteric artery tumor contact 180 ° or less",
                    "criterion": "superior mesenteric artery tumor contact",
                    "requirements": [
                        {
                            "requirement_type": "angle",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 180,
                                        "unit": "°"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The tumor contacts the aberrant arteries (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, etc.)",
                    "criterion": "aberrant arteries tumor contact",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(pancreatic body and tail tumors) tumor contact with superior mesenteric artery ≤180°",
                    "criterion": "superior mesenteric artery tumor contact (pancreatic body and tail tumors)",
                    "requirements": [
                        {
                            "requirement_type": "angle",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 180,
                                        "unit": "°"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor contact with celiac artery ≤180°",
                    "criterion": "celiac artery tumor contact",
                    "requirements": [
                        {
                            "requirement_type": "angle",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 180,
                                        "unit": "°"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above",
                    "criterion": "medical history",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "immune system diseases",
                                "other malignant tumors",
                                "myocarditis",
                                "coronary heart disease",
                                "other cardiovascular and cerebrovascular diseases",
                                "thyroid dysfunction",
                                "liver and kidney diseases",
                                "psychiatric diseases",
                                "infectious diseases",
                                "systemic diseases"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Participants were willing to join in this study, good adherence and written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Participants were willing to join in this study",
                    "criterion": "willingness to join study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "good adherence",
                    "criterion": "adherence",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "format",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who did not meet these inclusion criteria;",
            "criterions": [
                {
                    "exact_snippets": "did not meet these inclusion criteria",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;",
            "criterions": [
                {
                    "exact_snippets": "Poor cognitive ability",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to answer questions",
                    "criterion": "ability to answer questions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to fill out questionnaires",
                    "criterion": "ability to fill out questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mental disorders",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "3. The investigators think inappropriate.",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}