{
    "info": {
        "nct_id": "NCT05214976",
        "official_title": "A Phase Ⅰb/Ⅱ Clinical Study on the Open-label and Multiple Centers of Camrelizumab for Injection in Combination With Famitinib Malate Capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients",
        "inclusion_criteria": "1. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;\n2. Dose Escalation Period: Histopathologically documented incurable advanced malignancies with standard treatment failure;\n3. At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors;\n4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n5. Life expectancy ≥3 months;\n6. Adequate organ functions as defined;\n7. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. The imaging examinations shows the tumor invades large blood vessels; Or as the assessment of the investigator, the tumor is highly likely to invade important blood vessels which would cause fatal bleeding during treatment;\n2. The imaging examinations shows significant pulmonary cavitary tumors occurs with the bleeding risk as the investigator's assessment;\n3. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, or spinal cord compression;\n4. Uncontrollable pleural effusion, pericardial effusion or peritoneal effusion, with clinical symptoms;\n5. Severe bong injury caused by metastatic tumor of bone;\n6. Prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment;\n7. History of autoimmune diseases;\n8. Evidence or history of arterial/venous thrombosis within 6 months before the first dose;\n9. Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;\n10. When receiving immune checkpoint inhibitors previously, myocarditis related with immune, ≥ grade 2 of pneumonia related with immune or ≥ grade 3 of other adverse reactions related with immune occurred.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥18 years and ≤75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Dose Escalation Period: Histopathologically documented incurable advanced malignancies with standard treatment failure;",
            "criterions": [
                {
                    "exact_snippets": "Histopathologically documented incurable advanced malignancies",
                    "criterion": "advanced malignancies",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histopathologically"
                        },
                        {
                            "requirement_type": "curability",
                            "expected_value": "incurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "standard treatment failure",
                    "criterion": "treatment failure",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors;",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion that meets RECIST 1.1 criteria",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Life expectancy ≥3 months;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥3 months;",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate organ functions as defined;",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ functions",
                    "criterion": "organ functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily agrees to participate",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "giving written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. The imaging examinations shows the tumor invades large blood vessels; Or as the assessment of the investigator, the tumor is highly likely to invade important blood vessels which would cause fatal bleeding during treatment;",
            "criterions": [
                {
                    "exact_snippets": "imaging examinations shows the tumor invades large blood vessels",
                    "criterion": "tumor invasion of large blood vessels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "assessment of the investigator, the tumor is highly likely to invade important blood vessels",
                    "criterion": "likelihood of tumor invading important blood vessels",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The imaging examinations shows significant pulmonary cavitary tumors occurs with the bleeding risk as the investigator's assessment;",
            "criterions": [
                {
                    "exact_snippets": "imaging examinations shows significant pulmonary cavitary tumors",
                    "criterion": "pulmonary cavitary tumors",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding risk as the investigator's assessment",
                    "criterion": "bleeding risk",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "investigator's assessment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, or spinal cord compression;",
            "criterions": [
                {
                    "exact_snippets": "active brain metastasis (without medical control or with clinical symptoms)",
                    "criterion": "active brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "medical control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "clinical symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancerous meningitis",
                    "criterion": "cancerous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Uncontrollable pleural effusion, pericardial effusion or peritoneal effusion, with clinical symptoms;",
            "criterions": [
                {
                    "exact_snippets": "Uncontrollable pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "clinical symptoms"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable ... pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "clinical symptoms"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable ... peritoneal effusion",
                    "criterion": "peritoneal effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "clinical symptoms"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Severe bong injury caused by metastatic tumor of bone;",
            "criterions": [
                {
                    "exact_snippets": "Severe bong injury caused by metastatic tumor of bone",
                    "criterion": "bone injury",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "cause",
                            "expected_value": "metastatic tumor of bone"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment;",
            "criterions": [
                {
                    "exact_snippets": "Prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of autoimmune diseases;",
            "criterions": [
                {
                    "exact_snippets": "History of autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Evidence or history of arterial/venous thrombosis within 6 months before the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Evidence or history of arterial/venous thrombosis",
                    "criterion": "arterial/venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months before the first dose",
                    "criterion": "time since thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. When receiving immune checkpoint inhibitors previously, myocarditis related with immune, ≥ grade 2 of pneumonia related with immune or ≥ grade 3 of other adverse reactions related with immune occurred.",
            "criterions": [
                {
                    "exact_snippets": "myocarditis related with immune",
                    "criterion": "immune-related myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ grade 2 of pneumonia related with immune",
                    "criterion": "immune-related pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ grade 3 of other adverse reactions related with immune",
                    "criterion": "other immune-related adverse reactions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "9. Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;",
            "criterions": [
                {
                    "exact_snippets": "Patients with interstitial pneumonitis",
                    "criterion": "interstitial pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "past history of interstitial pneumonitis",
                    "criterion": "past history of interstitial pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "past history of interstitial lung disease",
                    "criterion": "past history of interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring hormone therapy",
                    "criterion": "hormone therapy requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}