{
    "info": {
        "nct_id": "NCT03941873",
        "official_title": "A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib as Monotherapy and in Combination With Tislelizumab in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic HCC/gastric cancer/GEJ cancer\n* Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments\n* Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)\n* Adequate organ function\n* Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drug(s), and have a negative serum pregnancy test ≤ 7 days of first dose of study drug(s)\n* Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)\n* Failed current standard-of-care treatment, or standard-of-care treatment is considered not appropriate at present\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Active leptomeningeal disease or uncontrolled brain metastasis\n* Active autoimmune diseases or history of autoimmune diseases that may relapse\n* Any active malignancy ≤ 2 years before first dose of study drug(s)\n* History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis or acute lung diseases\n* Severe chronic or active infections (including tuberculosis infection) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of study drug(s)\n* Known history of human immunodeficiency virus (HIV) infection\n* Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers.\n* Any major surgical procedure requiring general anesthesia ≤ 28 days before the first dose of study drug(s)\n* Prior allogeneic stem cell transplantation or organ transplantation\n* Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)\n* Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring\n* Any systemic chemotherapy within 28 days of the first dose of study drug(s) or hormone therapy, targeted therapy, or any investigational therapies\n* Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)\n* Inability to swallow capsules or disease significantly affecting gastrointestinal function\n* Pregnant or breastfeeding woman\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic HCC/gastric cancer/GEJ cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "cancer confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "resectability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "HCC/gastric cancer/GEJ cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "HCC",
                                "gastric cancer",
                                "GEJ cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments",
            "criterions": [
                {
                    "exact_snippets": "Able to provide written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "can understand and agree to comply with the requirements of the study",
                    "criterion": "understanding and agreement to comply",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "can understand and agree to comply with ... the schedule of assessments",
                    "criterion": "understanding and agreement to comply with schedule of assessments",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "legal age of consent in the jurisdiction",
                    "criterion": "legal age of consent",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": "legal age of consent in the jurisdiction"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drug(s), and have a negative serum pregnancy test ≤ 7 days of first dose of study drug(s)",
            "criterions": [
                {
                    "exact_snippets": "Females of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use a highly effective method of birth control",
                    "criterion": "birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "duration of the study, and ≥ 120 days after the last dose of study drug(s)",
                    "criterion": "birth control duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 120,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test ≤ 7 days of first dose of study drug(s)",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)",
            "criterions": [
                {
                    "exact_snippets": "Nonsterile males must be willing to use a highly effective method of birth control",
                    "criterion": "birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the duration of the study and for ≥ 120 days after the last dose of study drug(s)",
                    "criterion": "birth control usage duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 120,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failed current standard-of-care treatment, or standard-of-care treatment is considered not appropriate at present",
            "criterions": [
                {
                    "exact_snippets": "Failed current standard-of-care treatment",
                    "criterion": "standard-of-care treatment",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "standard-of-care treatment is considered not appropriate at present",
                    "criterion": "standard-of-care treatment",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Active leptomeningeal disease or uncontrolled brain metastasis",
            "criterions": [
                {
                    "exact_snippets": "Active leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune diseases or history of autoimmune diseases that may relapse",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of autoimmune diseases that may relapse",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "relapse potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any active malignancy ≤ 2 years before first dose of study drug(s)",
            "criterions": [
                {
                    "exact_snippets": "Any active malignancy ≤ 2 years before first dose of study drug(s)",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis or acute lung diseases",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "noninfectious pneumonitis",
                    "criterion": "noninfectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diseases including pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diseases including ... acute lung diseases",
                    "criterion": "acute lung diseases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe chronic or active infections (including tuberculosis infection) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of study drug(s)",
            "criterions": [
                {
                    "exact_snippets": "Severe chronic or active infections (including tuberculosis infection)",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "chronic or active"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring systemic antibacterial, antifungal, or antiviral therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "antibacterial",
                                "antifungal",
                                "antiviral"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days prior to first dose of study drug(s)",
                    "criterion": "time since last therapy",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of human immunodeficiency virus (HIV) infection",
            "criterions": [
                {
                    "exact_snippets": "Known history of human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers.",
            "criterions": [
                {
                    "exact_snippets": "Untreated chronic hepatitis B",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic hepatitis B virus (HBV) carriers",
                    "criterion": "chronic hepatitis B virus (HBV) carriers",
                    "requirements": [
                        {
                            "requirement_type": "carrier status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any major surgical procedure requiring general anesthesia ≤ 28 days before the first dose of study drug(s)",
            "criterions": [
                {
                    "exact_snippets": "major surgical procedure requiring general anesthesia ≤ 28 days before the first dose of study drug(s)",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allogeneic stem cell transplantation or organ transplantation",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic stem cell transplantation",
                    "criterion": "allogeneic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)",
            "criterions": [
                {
                    "exact_snippets": "Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequately controlled hypertension ... and/or diastolic blood pressure > 100 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring",
            "criterions": [
                {
                    "exact_snippets": "Bleeding or thrombotic disorders",
                    "criterion": "bleeding or thrombotic disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of anticoagulants such as warfarin or similar agents",
                    "criterion": "use of anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring therapeutic international normalized ratio (INR) monitoring",
                    "criterion": "therapeutic INR monitoring",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any systemic chemotherapy within 28 days of the first dose of study drug(s) or hormone therapy, targeted therapy, or any investigational therapies",
            "criterions": [
                {
                    "exact_snippets": "Any systemic chemotherapy within 28 days of the first dose of study drug(s)",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone therapy, targeted therapy, or any investigational therapies",
                    "criterion": "hormone therapy, targeted therapy, investigational therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)",
            "criterions": [
                {
                    "exact_snippets": "Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized",
                    "criterion": "toxicities from prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": "recovered to baseline or stabilized"
                        }
                    ]
                },
                {
                    "exact_snippets": "adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)",
                    "criterion": "adverse events",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to swallow capsules or disease significantly affecting gastrointestinal function",
            "criterions": [
                {
                    "exact_snippets": "Inability to swallow capsules",
                    "criterion": "ability to swallow capsules",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "disease significantly affecting gastrointestinal function",
                    "criterion": "gastrointestinal function",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding woman",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding woman",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria",
                    "criterion": "protocol defined criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ]
}