{
    "info": {
        "nct_id": "NCT03122548",
        "official_title": "A Phase 2, Open-label Evaluation of CRS-207 and Pembrolizumab in Adults With Recurrent or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinomas",
        "inclusion_criteria": "1. Diagnosis with confirmed histology of one or more of the following:\n\n   * Histologically-confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (Siewert type II/III classification), or\n   * Histologically-confirmed inoperable superior, medial, or distal third esophageal adenocarcinoma (Siewert type I classification may be included, provided there is no mixed histology)\n2. Confirmed recurrent or metastatic disease\n3. Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.\n4. HER-2/neu negative or, if HER-2/neu positive, disease must have previously progressed on treatment with trastuzumab; prior treatment must have included a platinum and a fluoropyrimidine.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. Can provide tissue for PD-L1 and mesothelin biomarker analysis\n7. Adequate organ and marrow function at screening\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Diagnosis of squamous or undifferentiated gastric cancer\n2. Individuals with inaccessible tumors or for whom biopsy is contraindicated\n3. Participated in any other study in which receipt of an investigational new drug or investigational device occurred within 28 days of first dose of study drug\n4. Receiving tumor necrosis factor (TNF) pathway inhibitors, PI3 kinase inhibitors, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n5. Clinical evidence of ascites by physical exam\n6. Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug or has not recovered from adverse effects due to agents administered more than 4 weeks earlier\n7. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug, or has not recovered from adverse effects due to a previously-administered agent\n8. Subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g. artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g. Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Diagnosis with confirmed histology of one or more of the following:",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis with confirmed histology",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histology"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically-confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (Siewert type II/III classification), or",
            "criterions": [
                {
                    "exact_snippets": "Histologically-confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma",
                    "criterion": "gastric or gastroesophageal junction adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically-confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Siewert type II/III classification",
                    "criterion": "Siewert classification",
                    "requirements": [
                        {
                            "requirement_type": "classification type",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically-confirmed inoperable superior, medial, or distal third esophageal adenocarcinoma (Siewert type I classification may be included, provided there is no mixed histology)",
            "criterions": [
                {
                    "exact_snippets": "Histologically-confirmed",
                    "criterion": "histology confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inoperable",
                    "criterion": "operability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "inoperable"
                        }
                    ]
                },
                {
                    "exact_snippets": "superior, medial, or distal third esophageal adenocarcinoma",
                    "criterion": "esophageal adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "superior third",
                                "medial third",
                                "distal third"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Siewert type I classification",
                    "criterion": "Siewert classification",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "I"
                        }
                    ]
                },
                {
                    "exact_snippets": "no mixed histology",
                    "criterion": "mixed histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Confirmed recurrent or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Confirmed recurrent or metastatic disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.",
            "criterions": [
                {
                    "exact_snippets": "Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.",
                    "criterion": "prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. HER-2/neu negative or, if HER-2/neu positive, disease must have previously progressed on treatment with trastuzumab; prior treatment must have included a platinum and a fluoropyrimidine.",
            "criterions": [
                {
                    "exact_snippets": "HER-2/neu negative",
                    "criterion": "HER-2/neu status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2/neu positive ... disease must have previously progressed on treatment with trastuzumab",
                    "criterion": "HER-2/neu status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "progression on trastuzumab",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior treatment must have included a platinum",
                    "criterion": "prior treatment with platinum",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior treatment must have included ... a fluoropyrimidine",
                    "criterion": "prior treatment with fluoropyrimidine",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Can provide tissue for PD-L1 and mesothelin biomarker analysis",
            "criterions": [
                {
                    "exact_snippets": "Can provide tissue for PD-L1 ... biomarker analysis",
                    "criterion": "PD-L1 biomarker analysis",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Can provide tissue for ... mesothelin biomarker analysis",
                    "criterion": "mesothelin biomarker analysis",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate organ and marrow function at screening",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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": "1. Diagnosis of squamous or undifferentiated gastric cancer",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of squamous or undifferentiated gastric cancer",
                    "criterion": "gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "squamous",
                                "undifferentiated"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Individuals with inaccessible tumors or for whom biopsy is contraindicated",
            "criterions": [
                {
                    "exact_snippets": "inaccessible tumors",
                    "criterion": "tumor accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy is contraindicated",
                    "criterion": "biopsy contraindication",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participated in any other study in which receipt of an investigational new drug or investigational device occurred within 28 days of first dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Participated in any other study in which receipt of an investigational new drug or investigational device occurred within 28 days of first dose of study drug",
                    "criterion": "participation in other study with investigational drug/device",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Receiving tumor necrosis factor (TNF) pathway inhibitors, PI3 kinase inhibitors, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Receiving tumor necrosis factor (TNF) pathway inhibitors",
                    "criterion": "TNF pathway inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving ... PI3 kinase inhibitors",
                    "criterion": "PI3 kinase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving ... systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving ... any other form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to the first dose of study drug",
                    "criterion": "time since last therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Clinical evidence of ascites by physical exam",
            "criterions": [
                {
                    "exact_snippets": "Clinical evidence of ascites by physical exam",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug or has not recovered from adverse effects due to agents administered more than 4 weeks earlier",
            "criterions": [
                {
                    "exact_snippets": "Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug",
                    "criterion": "prior anti-cancer monoclonal antibody",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has not recovered from adverse effects due to agents administered more than 4 weeks earlier",
                    "criterion": "recovery from adverse effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug, or has not recovered from adverse effects due to a previously-administered agent",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has not recovered from adverse effects due to a previously-administered agent",
                    "criterion": "recovery from adverse effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g. artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g. Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "implanted medical devices that pose high risks for colonization and cannot be easily removed",
                    "criterion": "implanted medical devices",
                    "requirements": [
                        {
                            "requirement_type": "risk for colonization",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "removability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "venous access devices (e.g. Port-a-Cath or Mediport) may be permitted",
                    "criterion": "venous access devices",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug",
                    "criterion": "arterial and venous stents and dental and breast implants",
                    "requirements": [
                        {
                            "requirement_type": "placement time",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}