{
    "info": {
        "nct_id": "NCT06834672",
        "official_title": "A Multicenter, Randomized, Open-label Phase III Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients with histological or cytological findings meet any of the following criteria:\n\n   1. Endometrioid tumor, clear cell tumor, mucinous tumor, mesenchymal tumor, or contains any of the above components.\n   2. Low-grade or borderline tumor, or contains any of the above components.\n2. Participation in any other interventional clinical study, except observational (non-interventional) study.\n3. Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.\n4. Prior therapy to first dose of study drug:\n\n   1. Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.\n   2. Participants who have been treated with oral chemotherapeutic drugs, small molecular targeted drugs, endocrine therapy, and Chinese herbal medicine for anticancer treatment indications, within 2 weeks or 5 half-lives (whichever is longer).\n   3. Participants who have been treated with radical radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks.\n   4. Participants who have been treated with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks or 5 half-lives (whichever is longer).\n   5. Participants who have been treated with Major surgery (craniotomy, thoracotomy or laparotomy and other types of surgery considered \"major\" by the investigator, excluding needle biopsy) within 4 weeks; Laparoscopic exploration surgery within 2 weeks. Or participants have serious non-healing wound, trauma or ulcer.\n   6. Participants who have been treated with live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live vaccines) within 4 weeks.\n5. Have adverse reactions caused by previous anti-tumor therapy that have not been resolved to Grade 0 or 1 according to NCI-CTCAE v5.0 criteria.\n6. Presence of symptomatic central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or history of leptomeningeal carcinoma.\n7. Participants with pneumonitis requiring corticosteroid treatment, or a history of other clinically significant lung disease.\n8. Uncontrolled or significant cardiovascular and cerebrovascular disease.\n9. Use of immunosuppressive medications within 14 days prior to the first dose of study treatment.\n10. Tumor invades surrounding important tissues or organs.\n11. Bleeding within 3 months prior to the first dose of study treatment.\n12. Symptomatic abdominal or pelvic effusion requiring intervention.\n13. Esophageal or gastric varices that require immediate intervention (e.g., ligation or sclerotherapy), or have high risk of bleeding considered by the investigator or gastroenterology and hepatology specialists; participants with evidence of portal hypertension.\n14. Unhealed gastrointestinal obstruction, perforation, or fistula, or participants at risk for gastrointestinal obstruction or perforation.\n15. Have intraluminal stenting of the digestive tract or trachea.\n16. Participants with biliary obstruction will be excluded.\n17. Participants with hepatic encephalopathy, hepatorenal syndrome, or cirrhosis of Child-Pugh class B or above.\n18. Significant malnutrition.\n19. Uncontrolled active infection.\n20. Concomitant other primary malignancies within 3 years or other malignancies with active or risk of recurrence before the first dose of study treatment.\n21. History of immunodeficiency disease, including congenital or acquired immunodeficiency disease.\n22. History of allogeneic organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.\n23. Allergy to other anti-HER2 antibodies/ADC or any component of IBI354.\n24. Participants who are pregnant or lactating, or those who plan to become pregnant.\n25. Other acute or chronic diseases or laboratory abnormalities that may increase the risk of participation in the study or administration of the study treatment, interfere with the interpretation of the study results, or lead the investigator to determine that the participant is inappropriate for participation in the study.\n26. The participant has neurological, psychiatric, or social conditions that affect trial compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent.",
        "miscellaneous_criteria": "Inclusion Criteria\n\n1. Participants have the ability to understand and give written informed consent Form (ICF) for participation in this trial, including all evaluations and procedures as specified by this protocol;\n2. Female participants ≥ 18 years old;\n3. Expected life time ≥ 12 weeks\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n5. Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian, primary peritoneal, or fallopian tube cancer.\n6. Must have confirmed disease progression during or after the most recent anticancer therapy.\n7. Must have at least 1 measurable target lesion per RECIST v1.1 criteria.\n8. Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to the first dose of study drug.\n9. Adequate bone marrow and organ function.\n10. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug and use effective contraception throughout the treatment period and for 6 months after the treatment period."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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. Patients with histological or cytological findings meet any of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "histological or cytological findings",
                    "criterion": "histological or cytological findings",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Endometrioid tumor, clear cell tumor, mucinous tumor, mesenchymal tumor, or contains any of the above components.",
            "criterions": [
                {
                    "exact_snippets": "Endometrioid tumor",
                    "criterion": "endometrioid tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clear cell tumor",
                    "criterion": "clear cell tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mucinous tumor",
                    "criterion": "mucinous tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mesenchymal tumor",
                    "criterion": "mesenchymal tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contains any of the above components",
                    "criterion": "tumor components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "endometrioid",
                                "clear cell",
                                "mucinous",
                                "mesenchymal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Low-grade or borderline tumor, or contains any of the above components.",
            "criterions": [
                {
                    "exact_snippets": "Low-grade or borderline tumor",
                    "criterion": "tumor grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "low-grade",
                                "borderline"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "contains any of the above components",
                    "criterion": "tumor components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "any of the above components"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participation in any other interventional clinical study, except observational (non-interventional) study.",
            "criterions": [
                {
                    "exact_snippets": "Participation in any other interventional clinical study",
                    "criterion": "participation in interventional clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.",
            "criterions": [
                {
                    "exact_snippets": "Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible",
                    "criterion": "control arm drugs",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan ... had previously received and progressed",
                    "criterion": "control arm drugs",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Prior therapy to first dose of study drug:",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy to first dose of study drug",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "before first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Participants who have been treated with Intravenous infusion of chemotherapeutic drugs",
                    "criterion": "treatment with intravenous infusion of chemotherapeutic drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants who have been treated with ... macromolecular targeted drugs",
                    "criterion": "treatment with macromolecular targeted drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants who have been treated with ... immunotherapy",
                    "criterion": "treatment with immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants who have been treated with ... intraperitoneal chemotherapy",
                    "criterion": "treatment with intraperitoneal chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants who have been treated with ... tumor embolization",
                    "criterion": "treatment with tumor embolization",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants who have been treated with ... interventional chemotherapy",
                    "criterion": "treatment with interventional chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participants who have been treated with radical radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks.",
            "criterions": [
                {
                    "exact_snippets": "treated with radical radiotherapy within 4 weeks",
                    "criterion": "radical radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with ... palliative radiotherapy within 2 weeks",
                    "criterion": "palliative radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participants who have been treated with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks or 5 half-lives (whichever is longer).",
            "criterions": [
                {
                    "exact_snippets": "treated with strong cytochrome P450 3A4 (CYP3A4) inhibitors",
                    "criterion": "treatment with CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with strong cytochrome P450 3A4 (CYP3A4) ... inducers",
                    "criterion": "treatment with CYP3A4 inducers",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Participants who have been treated with Major surgery (craniotomy, thoracotomy or laparotomy and other types of surgery considered \"major\" by the investigator, excluding needle biopsy) within 4 weeks; Laparoscopic exploration surgery within 2 weeks. Or participants have serious non-healing wound, trauma or ulcer.",
            "criterions": [
                {
                    "exact_snippets": "Participants who have been treated with Major surgery (craniotomy, thoracotomy or laparotomy and other types of surgery considered \"major\" by the investigator, excluding needle biopsy) within 4 weeks",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Laparoscopic exploration surgery within 2 weeks",
                    "criterion": "laparoscopic exploration surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participants have serious non-healing wound, trauma or ulcer",
                    "criterion": "serious non-healing wound, trauma or ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Participants who have been treated with live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live vaccines) within 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Participants who have been treated with live vaccines ... within 4 weeks.",
                    "criterion": "treatment with live vaccines",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "mRNA and non-replicating adenovirus vaccines are not considered live vaccines",
                    "criterion": "vaccine type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "mRNA",
                                "non-replicating adenovirus"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Have adverse reactions caused by previous anti-tumor therapy that have not been resolved to Grade 0 or 1 according to NCI-CTCAE v5.0 criteria.",
            "criterions": [
                {
                    "exact_snippets": "adverse reactions caused by previous anti-tumor therapy",
                    "criterion": "adverse reactions from previous anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": "Grade 0 or 1 according to NCI-CTCAE v5.0 criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Presence of symptomatic central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or history of leptomeningeal carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Presence of symptomatic central nervous system (CNS) metastases",
                    "criterion": "symptomatic CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of leptomeningeal carcinoma",
                    "criterion": "history of leptomeningeal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Participants with pneumonitis requiring corticosteroid treatment, or a history of other clinically significant lung disease.",
            "criterions": [
                {
                    "exact_snippets": "pneumonitis requiring corticosteroid treatment",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "corticosteroid"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of other clinically significant lung disease",
                    "criterion": "clinically significant lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Uncontrolled or significant cardiovascular and cerebrovascular disease.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled or significant cardiovascular ... disease.",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled or significant ... cerebrovascular disease.",
                    "criterion": "cerebrovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Use of immunosuppressive medications within 14 days prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Use of immunosuppressive medications within 14 days prior to the first dose of study treatment.",
                    "criterion": "immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Tumor invades surrounding important tissues or organs.",
            "criterions": [
                {
                    "exact_snippets": "Tumor invades surrounding important tissues or organs.",
                    "criterion": "tumor invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Bleeding within 3 months prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Bleeding within 3 months prior to the first dose of study treatment.",
                    "criterion": "bleeding",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Symptomatic abdominal or pelvic effusion requiring intervention.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic abdominal or pelvic effusion requiring intervention",
                    "criterion": "abdominal or pelvic effusion",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "intervention requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Esophageal or gastric varices that require immediate intervention (e.g., ligation or sclerotherapy), or have high risk of bleeding considered by the investigator or gastroenterology and hepatology specialists; participants with evidence of portal hypertension.",
            "criterions": [
                {
                    "exact_snippets": "Esophageal or gastric varices that require immediate intervention (e.g., ligation or sclerotherapy)",
                    "criterion": "esophageal or gastric varices",
                    "requirements": [
                        {
                            "requirement_type": "immediate intervention",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Esophageal or gastric varices ... have high risk of bleeding considered by the investigator or gastroenterology and hepatology specialists",
                    "criterion": "esophageal or gastric varices",
                    "requirements": [
                        {
                            "requirement_type": "risk of bleeding",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "participants with evidence of portal hypertension",
                    "criterion": "portal hypertension",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Unhealed gastrointestinal obstruction, perforation, or fistula, or participants at risk for gastrointestinal obstruction or perforation.",
            "criterions": [
                {
                    "exact_snippets": "Unhealed gastrointestinal obstruction",
                    "criterion": "gastrointestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Unhealed gastrointestinal ... perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Unhealed gastrointestinal ... fistula",
                    "criterion": "gastrointestinal fistula",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    ]
                },
                {
                    "exact_snippets": "participants at risk for gastrointestinal obstruction",
                    "criterion": "risk for gastrointestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "risk status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participants at risk for gastrointestinal ... perforation",
                    "criterion": "risk for gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "risk status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Have intraluminal stenting of the digestive tract or trachea.",
            "criterions": [
                {
                    "exact_snippets": "intraluminal stenting of the digestive tract",
                    "criterion": "intraluminal stenting of the digestive tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intraluminal stenting of the ... trachea",
                    "criterion": "intraluminal stenting of the trachea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Participants with biliary obstruction will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "biliary obstruction",
                    "criterion": "biliary obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Participants with hepatic encephalopathy, hepatorenal syndrome, or cirrhosis of Child-Pugh class B or above.",
            "criterions": [
                {
                    "exact_snippets": "Participants with hepatic encephalopathy",
                    "criterion": "hepatic encephalopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants with ... hepatorenal syndrome",
                    "criterion": "hepatorenal syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants with ... cirrhosis of Child-Pugh class B or above",
                    "criterion": "cirrhosis of Child-Pugh class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Child-Pugh class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Significant malnutrition.",
            "criterions": [
                {
                    "exact_snippets": "Significant malnutrition",
                    "criterion": "malnutrition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Uncontrolled active infection.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Concomitant other primary malignancies within 3 years or other malignancies with active or risk of recurrence before the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant other primary malignancies within 3 years",
                    "criterion": "concomitant primary malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignancies with active or risk of recurrence before the first dose of study treatment",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "risk of recurrence"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. History of immunodeficiency disease, including congenital or acquired immunodeficiency disease.",
            "criterions": [
                {
                    "exact_snippets": "History of immunodeficiency disease",
                    "criterion": "immunodeficiency disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital or acquired immunodeficiency disease",
                    "criterion": "immunodeficiency disease",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "congenital",
                                "acquired"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. History of allogeneic organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.",
            "criterions": [
                {
                    "exact_snippets": "History of allogeneic organ transplantation",
                    "criterion": "allogeneic organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... allogeneic bone marrow transplantation",
                    "criterion": "allogeneic bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... autologous hematopoietic stem cell transplantation",
                    "criterion": "autologous hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Allergy to other anti-HER2 antibodies/ADC or any component of IBI354.",
            "criterions": [
                {
                    "exact_snippets": "Allergy to other anti-HER2 antibodies/ADC",
                    "criterion": "allergy to anti-HER2 antibodies/ADC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy to ... any component of IBI354",
                    "criterion": "allergy to any component of IBI354",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. Participants who are pregnant or lactating, or those who plan to become pregnant.",
            "criterions": [
                {
                    "exact_snippets": "Participants who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to become pregnant",
                    "criterion": "intention to become pregnant",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "25. Other acute or chronic diseases or laboratory abnormalities that may increase the risk of participation in the study or administration of the study treatment, interfere with the interpretation of the study results, or lead the investigator to determine that the participant is inappropriate for participation in the study.",
            "criterions": [
                {
                    "exact_snippets": "Other acute or chronic diseases",
                    "criterion": "acute or chronic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormalities",
                    "criterion": "laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "26. The participant has neurological, psychiatric, or social conditions that affect trial compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "neurological, psychiatric, or social conditions",
                    "criterion": "neurological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on trial",
                            "expected_value": "affect trial compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "neurological, psychiatric, or social conditions",
                    "criterion": "psychiatric conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on trial",
                            "expected_value": "affect trial compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "neurological, psychiatric, or social conditions",
                    "criterion": "social conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on trial",
                            "expected_value": "affect trial compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "1. Participants have the ability to understand and give written informed consent Form (ICF) for participation in this trial, including all evaluations and procedures as specified by this protocol;",
            "criterions": [
                {
                    "exact_snippets": "ability to understand and give written informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Female participants ≥ 18 years old;",
            "criterions": [
                {
                    "exact_snippets": "Female participants",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Expected life time ≥ 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Expected life time ≥ 12 weeks",
                    "criterion": "expected life time",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.",
                    "criterion": "Eastern Cooperative Oncology Group Performance Status (ECOG PS)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian, primary peritoneal, or fallopian tube cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "cancer confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced unresectable or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian, primary peritoneal, or fallopian tube cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "ovarian",
                                "primary peritoneal",
                                "fallopian tube"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Must have confirmed disease progression during or after the most recent anticancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "confirmed disease progression during or after the most recent anticancer therapy",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "during or after the most recent anticancer therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Must have at least 1 measurable target lesion per RECIST v1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "at least 1 measurable target lesion per RECIST v1.1 criteria",
                    "criterion": "measurable target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Left Ventricular Ejection Fraction (LVEF) ≥ 50%",
                    "criterion": "Left Ventricular Ejection Fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 28 days prior to the first dose of study drug",
                    "criterion": "timeframe for LVEF measurement",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 28 days prior to the first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug and use effective contraception throughout the treatment period and for 6 months after the treatment period.",
            "criterions": [
                {
                    "exact_snippets": "Female participants of childbearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test within 7 days prior to the first dose of study drug",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the first dose of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "use effective contraception throughout the treatment period and for 6 months after the treatment period",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the treatment period and for 6 months after the treatment period"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "2. Participants who have been treated with oral chemotherapeutic drugs, small molecular targeted drugs, endocrine therapy, and Chinese herbal medicine for anticancer treatment indications, within 2 weeks or 5 half-lives (whichever is longer).",
            "criterions": [
                {
                    "exact_snippets": "treated with oral chemotherapeutic drugs",
                    "criterion": "treatment with oral chemotherapeutic drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with small molecular targeted drugs",
                    "criterion": "treatment with small molecular targeted drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with endocrine therapy",
                    "criterion": "treatment with endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with Chinese herbal medicine for anticancer treatment indications",
                    "criterion": "treatment with Chinese herbal medicine for anticancer treatment indications",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "9. Adequate bone marrow and organ function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ]
}