{
    "info": {
        "nct_id": "NCT06496373",
        "official_title": "Clinical Study of XP-004 Personalized mRNA Tumor Vaccine Combined With PD-1 Inhibitor for Postoperative Adjuvant Therapy for Pancreatic Cancer in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "1. Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment\n2. Subjects must be >/= 18 years of age at time of informed consent, regardless of gender\n3. Patients who have been confirmed by pathology to have pancreatic malignant tumors and have undergone radical surgery for pancreatic malignant tumors for 1-3 months\n4. No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity, LOH) were found in HLA-related genes and chromosomal regions by gene sequencing\n5. Having tumor tissue confirmed by immunohistochemistry, capable of performing WES and RNAseq sequencing, and predicted by bioinformatics analysis, it was found that there is at least one antigen in the table that has been effectively presented by self-HLA, such as KRAS or TP53 mutations and corresponding HLA subtypes\n6. According to the investigator's assessment, the patient is unable to tolerate chemotherapy, such as the score of the Eastern Cooperative Oncology Group (ECOG) Performance Scale ≥ 2 points\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Has had chemotherapy, hormone therapy, traditional Chinese medicine, or biological cancer(for mitomycin and nitrosoureas within 6 weeks from the first dose of the drug in this study)， prior to the first dose of study therapytherapy within 4 weeks ,Or within 5 half-lives of immunotherapy, molecular targeted therapy\n2. History of interstitial lung disease (ILD), pulmonary fibrosis\n3. Other serious and/or uncontrollable diseases, which may affect the subject's participation in this study, include but not limited to a) a history of severe drug allergy, or is known to be allergic to any tumor vaccine and pembrolizumab formulation components or has had severe allergic reactions to other monoclonal antibodies in the past, b) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases\n4. Researchers believe that there are other reasons that are not suitable for participating in clinical trials",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment",
            "criterions": [
                {
                    "exact_snippets": "Subjects voluntarily signed written informed consent files",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to comply with the study protocol, in the investigator's judgment",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subjects must be >/= 18 years of age at time of informed consent, regardless of gender",
            "criterions": [
                {
                    "exact_snippets": "Subjects must be >/= 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "regardless of gender",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who have been confirmed by pathology to have pancreatic malignant tumors and have undergone radical surgery for pancreatic malignant tumors for 1-3 months",
            "criterions": [
                {
                    "exact_snippets": "confirmed by pathology to have pancreatic malignant tumors",
                    "criterion": "pancreatic malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathology"
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone radical surgery for pancreatic malignant tumors",
                    "criterion": "radical surgery for pancreatic malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone radical surgery ... for 1-3 months",
                    "criterion": "time since radical surgery",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity, LOH) were found in HLA-related genes and chromosomal regions by gene sequencing",
            "criterions": [
                {
                    "exact_snippets": "No copy number variations (CNVs) ... in HLA-related genes and chromosomal regions",
                    "criterion": "copy number variations (CNVs) in HLA-related genes and chromosomal regions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... loss of heterozygosity (Loss-of heterozygosity, LOH) ... in HLA-related genes and chromosomal regions",
                    "criterion": "loss of heterozygosity (LOH) in HLA-related genes and chromosomal regions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Having tumor tissue confirmed by immunohistochemistry, capable of performing WES and RNAseq sequencing, and predicted by bioinformatics analysis, it was found that there is at least one antigen in the table that has been effectively presented by self-HLA, such as KRAS or TP53 mutations and corresponding HLA subtypes",
            "criterions": [
                {
                    "exact_snippets": "tumor tissue confirmed by immunohistochemistry",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "immunohistochemistry"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor tissue ... capable of performing WES and RNAseq sequencing",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "sequencing capability",
                            "expected_value": [
                                "WES",
                                "RNAseq"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor tissue ... predicted by bioinformatics analysis",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "prediction method",
                            "expected_value": "bioinformatics analysis"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one antigen in the table that has been effectively presented by self-HLA",
                    "criterion": "antigen presentation by self-HLA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "KRAS or TP53 mutations",
                    "criterion": "KRAS or TP53 mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "corresponding HLA subtypes",
                    "criterion": "HLA subtypes",
                    "requirements": [
                        {
                            "requirement_type": "correspondence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. According to the investigator's assessment, the patient is unable to tolerate chemotherapy, such as the score of the Eastern Cooperative Oncology Group (ECOG) Performance Scale ≥ 2 points",
            "criterions": [
                {
                    "exact_snippets": "unable to tolerate chemotherapy",
                    "criterion": "chemotherapy tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "score of the Eastern Cooperative Oncology Group (ECOG) Performance Scale ≥ 2 points",
                    "criterion": "ECOG Performance Scale score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "points"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "2. History of interstitial lung disease (ILD), pulmonary fibrosis",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial lung disease (ILD)",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Other serious and/or uncontrollable diseases, which may affect the subject's participation in this study, include but not limited to a) a history of severe drug allergy, or is known to be allergic to any tumor vaccine and pembrolizumab formulation components or has had severe allergic reactions to other monoclonal antibodies in the past, b) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases",
            "criterions": [
                {
                    "exact_snippets": "a history of severe drug allergy",
                    "criterion": "severe drug allergy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is known to be allergic to any tumor vaccine",
                    "criterion": "allergy to tumor vaccine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is known to be allergic to ... pembrolizumab formulation components",
                    "criterion": "allergy to pembrolizumab formulation components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has had severe allergic reactions to other monoclonal antibodies in the past",
                    "criterion": "severe allergic reactions to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "positive",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other acquired or congenital immunodeficiency diseases",
                    "criterion": "acquired or congenital immunodeficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Researchers believe that there are other reasons that are not suitable for participating in clinical trials",
            "criterions": [
                {
                    "exact_snippets": "other reasons that are not suitable for participating in clinical trials",
                    "criterion": "suitability for clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "1. Has had chemotherapy, hormone therapy, traditional Chinese medicine, or biological cancer(for mitomycin and nitrosoureas within 6 weeks from the first dose of the drug in this study)， prior to the first dose of study therapytherapy within 4 weeks ,Or within 5 half-lives of immunotherapy, molecular targeted therapy",
            "criterions": [
                {
                    "exact_snippets": "Has had chemotherapy ... prior to the first dose of study therapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had hormone therapy ... prior to the first dose of study therapy",
                    "criterion": "prior hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had traditional Chinese medicine ... prior to the first dose of study therapy",
                    "criterion": "prior traditional Chinese medicine",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had biological cancer(for mitomycin and nitrosoureas within 6 weeks from the first dose of the drug in this study) ... prior to the first dose of study therapy",
                    "criterion": "prior biological cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 5 half-lives of immunotherapy",
                    "criterion": "prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": "within 5 half-lives"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 5 half-lives of ... molecular targeted therapy",
                    "criterion": "prior molecular targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": "within 5 half-lives"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}