{
    "info": {
        "nct_id": "NCT05841420",
        "official_title": "A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer",
        "inclusion_criteria": "* Age ≥ 18 years\n* Adenocarcinoma of the pancreas, histopathologically or cytologically verified\n* Non-resectable (locally advanced or metastatic) PC\n* Patients unfit or not candidate for full-dose combination chemotherapy\n* Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy\n* Performance status (PS) ≤2\n* Measurable or non-measurable disease\n* Adequate hematologic function defined as absolute neutrophil count (ANC) ≥1.5 x 10^9/l and platelets count ≥100x10^9/l within 2 weeks prior to enrollment\n* Adequate organ function (bilirubin ≤1.5 x UNL (Upper Normal Limit) and eGFR (estimated Glomerular Filtration Rate) >50ml/min within 2 weeks prior to enrollment\n* Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE <grade 2\n* Oral and written informed consent must be obtained according to the local Ethics committee requirements\n* Fertile patients must use adequate contraceptives\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation\n* Prior chemotherapy for PC (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)\n* Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma\n* Concurrent treatment with any other anti-cancer therapy\n* Pregnant or breast-feeding patients\n* Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons.\n* Other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.\n* Known allergy or intolerance to any of the drugs used in DPCG-01 (Gemcitabine, S1 or Nab-Paclitaxel)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adenocarcinoma of the pancreas, histopathologically or cytologically verified",
            "criterions": [
                {
                    "exact_snippets": "Adenocarcinoma of the pancreas",
                    "criterion": "adenocarcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histopathologically or cytologically verified",
                    "criterion": "verification method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histopathologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unfit or not candidate for full-dose combination chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Patients unfit or not candidate for full-dose combination chemotherapy",
                    "criterion": "fitness for full-dose combination chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Patients eligible for full dose gemcitabine",
                    "criterion": "gemcitabine eligibility",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "full"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients eligible for ... reduced dose combination chemotherapy",
                    "criterion": "combination chemotherapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "reduced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status (PS) ≤2",
            "criterions": [
                {
                    "exact_snippets": "Performance status (PS) ≤2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable or non-measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable or non-measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic function defined as absolute neutrophil count (ANC) ≥1.5 x 10^9/l and platelets count ≥100x10^9/l within 2 weeks prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic function defined as absolute neutrophil count (ANC) ≥1.5 x 10^9/l",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function defined as ... platelets count ≥100x10^9/l",
                    "criterion": "platelets count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function (bilirubin ≤1.5 x UNL (Upper Normal Limit) and eGFR (estimated Glomerular Filtration Rate) >50ml/min within 2 weeks prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "bilirubin ≤1.5 x UNL (Upper Normal Limit)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "eGFR (estimated Glomerular Filtration Rate) >50ml/min",
                    "criterion": "eGFR",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE <grade 2",
            "criterions": [
                {
                    "exact_snippets": "Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE <grade 2",
                    "criterion": "toxicity of prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neurotoxicity, resolved to CTCAE <grade 2",
                    "criterion": "neurotoxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Oral and written informed consent must be obtained according to the local Ethics committee requirements",
            "criterions": [
                {
                    "exact_snippets": "Oral and written informed consent must be obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "according to the local Ethics committee requirements",
                    "criterion": "local Ethics committee requirements",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use adequate contraceptives",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use adequate contraceptives",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation",
            "criterions": [
                {
                    "exact_snippets": "eligible for downstaging/preoperative chemotherapy",
                    "criterion": "downstaging/preoperative chemotherapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for ... resection",
                    "criterion": "resection eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for ... local ablation",
                    "criterion": "local ablation eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for ... irradiation",
                    "criterion": "irradiation eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy for PC (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy for PC",
                    "criterion": "prior chemotherapy for PC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible",
                    "criterion": "recurrence after adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since recurrence",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma",
                    "criterion": "malignant neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "non-curatively treated"
                        },
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "pancreatic adenocarcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent treatment with any other anti-cancer therapy",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with any other anti-cancer therapy",
                    "criterion": "concurrent anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding patients",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons.",
            "criterions": [
                {
                    "exact_snippets": "Patients clearly intending to withdraw from the study if not randomized in the willing arm",
                    "criterion": "intention to withdraw",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "clearly intending to withdraw if not randomized in the willing arm"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons",
                    "criterion": "ability to be regularly followed up",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.",
            "criterions": [
                {
                    "exact_snippets": "Other condition or therapy, which in the investigator's opinion may pose a risk to the patient",
                    "criterion": "other condition or therapy",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "may pose a risk to the patient"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other condition or therapy, which in the investigator's opinion may ... interfere with the study objectives",
                    "criterion": "other condition or therapy",
                    "requirements": [
                        {
                            "requirement_type": "interference assessment",
                            "expected_value": "may interfere with the study objectives"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known allergy or intolerance to any of the drugs used in DPCG-01 (Gemcitabine, S1 or Nab-Paclitaxel)",
            "criterions": [
                {
                    "exact_snippets": "Known allergy or intolerance to any of the drugs used in DPCG-01 (Gemcitabine, S1 or Nab-Paclitaxel)",
                    "criterion": "allergy or intolerance to drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Non-resectable (locally advanced or metastatic) PC",
            "criterions": [
                {
                    "exact_snippets": "Non-resectable",
                    "criterion": "resectability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-resectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic PC",
                    "criterion": "pancreatic cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}