{
    "info": {
        "nct_id": "NCT05378048",
        "official_title": "Patient-derived-organoid (PDO) Guided Versus Conventional Therapy for Advanced Inoperable Abdominal Tumors: a Multicenter Open-label, Proof of Concept, Phase 2 Randomised Controlled Trial",
        "inclusion_criteria": "* patients should be older than 18 years, able to provide written consents to trial participation, with Eastern cooperative oncology group performance status of 0 or 1, With measurable disease in accordance with response evaluation criteria in solid tumours (RECIST) version 11. [ 10 ] With a neutrophil count, hemoglobin > 9g/dl, serum creatinine <1.5 x upper limit of normal, serum bilirubin < 1.5 x normal, and aspartate and alanine aminotransferases (<3 x ULN or <5x in those with liver metastasis) Ejection Fraction >50% of normal. The disease is accessible for a biopsy (radiologic or endoscopic) or resection of a metastatic site.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "* unable to give consent, could not obtain a biopsy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* patients should be older than 18 years, able to provide written consents to trial participation, with Eastern cooperative oncology group performance status of 0 or 1, With measurable disease in accordance with response evaluation criteria in solid tumours (RECIST) version 11. [ 10 ] With a neutrophil count, hemoglobin > 9g/dl, serum creatinine <1.5 x upper limit of normal, serum bilirubin < 1.5 x normal, and aspartate and alanine aminotransferases (<3 x ULN or <5x in those with liver metastasis) Ejection Fraction >50% of normal. The disease is accessible for a biopsy (radiologic or endoscopic) or resection of a metastatic site.",
            "criterions": [
                {
                    "exact_snippets": "patients should be older than 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "able to provide written consents to trial participation",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "ability to provide",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern cooperative oncology group performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease in accordance with response evaluation criteria in solid tumours (RECIST) version 11",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "RECIST version",
                            "expected_value": "11"
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophil count",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin > 9g/dl",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "minimum level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine <1.5 x upper limit of normal",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum bilirubin < 1.5 x normal",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate and alanine aminotransferases (<3 x ULN or <5x in those with liver metastasis)",
                    "criterion": "aspartate and alanine aminotransferases",
                    "requirements": [
                        {
                            "requirement_type": "maximum level without liver metastasis",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        },
                        {
                            "requirement_type": "maximum level with liver metastasis",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Ejection Fraction >50% of normal",
                    "criterion": "ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "minimum percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "% of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "disease is accessible for a biopsy (radiologic or endoscopic) or resection of a metastatic site",
                    "criterion": "disease accessibility for biopsy or resection",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* unable to give consent, could not obtain a biopsy",
            "criterions": [
                {
                    "exact_snippets": "unable to give consent",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "could not obtain a biopsy",
                    "criterion": "biopsy",
                    "requirements": [
                        {
                            "requirement_type": "obtainability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}