{
    "info": {
        "nct_id": "NCT04564482",
        "official_title": "Programmed Death-ligand 1 Positron Emission Tomography Imaging During Neoadjuvant (Chemo)radiothErapy in Esophageal and Rectal Cancer (PETNEC): a Prospective Non-randomized Open-label Single-center Pilot Study",
        "inclusion_criteria": "* 18 years of age and older\n* All sexes\n* Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers)\n* Medical need for a neoadjuvant CRT/SCPRT\n* Suitable to withstand the course of neoadjuvant CRT/SCPRT\n* Written informed consent form (ICF) for participation in the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "* Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend)\n* Previous surgery of the tumor other than biopsy\n* Pregnancy, breastfeeding or expectancy to conceive\n* Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy\n* Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy\n* Hepatitis B or C\n* Human immunodeficiency virus (HIV)\n* Immunodeficiency\n* Allogeneic tissue or solid organ transplantation\n* Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs\n* Active non-infectious pneumonitis\n* Active infection requiring systemic therapy\n* Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment\n* Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers\n* Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment\n* Participants with serious or uncontrolled medical disorders\n* Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males > 450 ms and > 470 ms in females, participants with history of myocarditis)\n* Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)\n* Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18 years of age and older",
            "criterions": [
                {
                    "exact_snippets": "18 years of age and older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All sexes",
            "criterions": [
                {
                    "exact_snippets": "All sexes",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed carcinoma of the rectum",
                    "criterion": "carcinoma of the rectum",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed carcinoma of the ... oesophagus",
                    "criterion": "carcinoma of the oesophagus",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "oesophago-gastric junction cancers",
                    "criterion": "oesophago-gastric junction cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical need for a neoadjuvant CRT/SCPRT",
            "criterions": [
                {
                    "exact_snippets": "Medical need for a neoadjuvant CRT/SCPRT",
                    "criterion": "neoadjuvant CRT/SCPRT",
                    "requirements": [
                        {
                            "requirement_type": "medical need",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suitable to withstand the course of neoadjuvant CRT/SCPRT",
            "criterions": [
                {
                    "exact_snippets": "Suitable to withstand the course of neoadjuvant CRT/SCPRT",
                    "criterion": "suitability for neoadjuvant CRT/SCPRT",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent form (ICF) for participation in the study",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent form (ICF) for participation in the study",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend)",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "incurability by local therapies",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "oligometastatic disease with a curative intend",
                    "criterion": "oligometastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "curative intent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous surgery of the tumor other than biopsy",
            "criterions": [
                {
                    "exact_snippets": "Previous surgery of the tumor other than biopsy",
                    "criterion": "previous surgery of the tumor",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy, breastfeeding or expectancy to conceive",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expectancy to conceive",
                    "criterion": "expectancy to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with anti-CTLA-4",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "agent",
                            "expected_value": "anti-CTLA-4"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... anti-PD-1",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "agent",
                            "expected_value": "anti-PD-1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... anti-PD-L1",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "agent",
                            "expected_value": "anti-PD-L1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... anti-PD-L2",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "agent",
                            "expected_value": "anti-PD-L2"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... any other agent directed against co-inhibitory T cell receptors",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "agent",
                            "expected_value": "any other agent directed against co-inhibitory T cell receptors"
                        }
                    ]
                },
                {
                    "exact_snippets": "has previously participated in clinical studies with immunotherapy",
                    "criterion": "previous participation in clinical studies",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "immunotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy",
            "criterions": [
                {
                    "exact_snippets": "Disagreement of participants with reproductive potential to use contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participants with reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV)",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV)",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunodeficiency",
            "criterions": [
                {
                    "exact_snippets": "Immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allogeneic tissue or solid organ transplantation",
            "criterions": [
                {
                    "exact_snippets": "Allogeneic tissue or solid organ transplantation",
                    "criterion": "allogeneic tissue transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Allogeneic tissue or solid organ transplantation",
                    "criterion": "solid organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "systemic therapy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        },
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "modifying agents",
                                "steroids",
                                "immunosuppressive drugs"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active non-infectious pneumonitis",
            "criterions": [
                {
                    "exact_snippets": "Active non-infectious pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "infection status",
                            "expected_value": "non-infectious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment",
                    "criterion": "use of systemic steroids or immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed and/or treated additional malignancy within 5 years of randomization",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively-treated basal cell or squamous cell carcinoma of the skin",
                    "criterion": "basal cell or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively-resected in situ cervical and/or breast cancers",
                    "criterion": "in situ cervical and/or breast cancers",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "curative resection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment",
            "criterions": [
                {
                    "exact_snippets": "Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) ... within 2 weeks prior to randomization/treatment",
                    "criterion": "treatment with botanical preparations",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with serious or uncontrolled medical disorders",
            "criterions": [
                {
                    "exact_snippets": "serious or uncontrolled medical disorders",
                    "criterion": "medical disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males > 450 ms and > 470 ms in females, participants with history of myocarditis)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled or significant cardiovascular disease (myocardial infarction",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any history of clinically significant arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc prolongation in males > 450 ms",
                    "criterion": "QTc prolongation in males",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc prolongation ... > 470 ms in females",
                    "criterion": "QTc prolongation in females",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participants with history of myocarditis",
                    "criterion": "myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)",
            "criterions": [
                {
                    "exact_snippets": "history of allergy or hypersensitivity to study drug components",
                    "criterion": "allergy or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications to any of the study drugs of the chemotherapy regimen",
                    "criterion": "contraindications to study drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness",
            "criterions": [
                {
                    "exact_snippets": "Prisoners or participants who are involuntarily incarcerated",
                    "criterion": "incarceration status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "prisoner or involuntarily incarcerated"
                        }
                    ]
                },
                {
                    "exact_snippets": "participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness",
                    "criterion": "compulsory detention for treatment",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": [
                                "psychiatric illness",
                                "physical illness (i.e. infectious disease)"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Hepatitis B or C",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}