[96a5a0]: / output / allTrials / logical / NCT06047431_logical.json

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{
"info": {
"nct_id": "NCT06047431",
"official_title": "A Phase Ⅰ Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of QL1706H in Advanced Solid Tumors",
"inclusion_criteria": "* Subjects participate voluntarily and sign informed consent.\n* Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors, failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery\n* Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.\n* Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.\n* The extension of life is more than 3 months\n* Vital organs' function is adequate for enrolling\n* Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.\n* Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.\n* There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy.\n* Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent.\n* Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study\n* Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period\n* Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor, or CTLA-4 inhibitor combined with PD-L1 inhibitor.\n* Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs\n* Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) >2000 IU/ mL or 10^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Subjects participate voluntarily and sign informed consent.",
"criterions": [
{
"exact_snippets": "Subjects participate voluntarily",
"criterion": "voluntary participation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sign informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Subjects participate voluntarily",
"criterion": "voluntary participation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sign informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors, failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery",
"criterions": [
{
"exact_snippets": "Pathologically confirmed metastatic or recurrent malignant solid tumors",
"criterion": "metastatic or recurrent malignant solid tumors",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "failure or intolerance of at least first-line treatment",
"criterion": "first-line treatment",
"requirement": {
"requirement_type": "response",
"expected_value": [
"failure",
"intolerance"
]
}
},
{
"exact_snippets": "unsuitable for radical treatment such as surgery",
"criterion": "radical treatment",
"requirement": {
"requirement_type": "suitability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Pathologically confirmed metastatic or recurrent malignant solid tumors",
"criterion": "metastatic or recurrent malignant solid tumors",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "failure or intolerance of at least first-line treatment",
"criterion": "first-line treatment",
"requirement": {
"requirement_type": "response",
"expected_value": [
"failure",
"intolerance"
]
}
}
]
},
{
"exact_snippets": "unsuitable for radical treatment such as surgery",
"criterion": "radical treatment",
"requirement": {
"requirement_type": "suitability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria.",
"criterions": [
{
"exact_snippets": "at least one measurable lesion according to RECIST (V1.1) evaluation criteria",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "at least one measurable lesion according to RECIST (V1.1) evaluation criteria",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.",
"criterion": "ECOG score",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score was 0 or 1.",
"criterion": "ECOG score",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
}
},
{
"identified_line": {
"line": "* The extension of life is more than 3 months",
"criterions": [
{
"exact_snippets": "The extension of life is more than 3 months",
"criterion": "extension of life",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The extension of life is more than 3 months",
"criterion": "extension of life",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Vital organs' function is adequate for enrolling",
"criterions": [
{
"exact_snippets": "Vital organs' function is adequate",
"criterion": "vital organs' function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Vital organs' function is adequate",
"criterion": "vital organs' function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding.",
"criterions": [
{
"exact_snippets": "Subjects agree to use effective contraceptive measures",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "Women who have not been pregnant",
"criterion": "pregnancy history",
"requirement": {
"requirement_type": "history",
"expected_value": "not been pregnant"
}
},
{
"exact_snippets": "Women who have not been ... breastfeeding",
"criterion": "breastfeeding history",
"requirement": {
"requirement_type": "history",
"expected_value": "not been breastfeeding"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Subjects agree to use effective contraceptive measures",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "Women who have not been pregnant",
"criterion": "pregnancy history",
"requirement": {
"requirement_type": "history",
"expected_value": "not been pregnant"
}
}
]
},
{
"exact_snippets": "Women who have not been ... breastfeeding",
"criterion": "breastfeeding history",
"requirement": {
"requirement_type": "history",
"expected_value": "not been breastfeeding"
}
}
]
}
},
{
"identified_line": {
"line": "* Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity.",
"criterions": [
{
"exact_snippets": "all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0)",
"criterion": "reversible toxicity of previous antitumor therapy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "CTCAE V5.0"
}
}
},
{
"exact_snippets": "Excluding any grade of hair loss",
"criterion": "hair loss",
"requirement": {
"requirement_type": "severity",
"expected_value": "any grade"
}
},
{
"exact_snippets": "Excluding ... grade 2 or less peripheral sensory neuropathy",
"criterion": "peripheral sensory neuropathy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "grade"
}
}
},
{
"exact_snippets": "Excluding ... other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity",
"criterion": "other abnormalities",
"requirement": {
"requirement_type": "assessment",
"expected_value": "outweigh the risk of toxicity"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Excluding any grade of hair loss",
"criterion": "hair loss",
"requirement": {
"requirement_type": "severity",
"expected_value": "any grade"
}
},
{
"exact_snippets": "Excluding ... grade 2 or less peripheral sensory neuropathy",
"criterion": "peripheral sensory neuropathy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "grade"
}
}
},
{
"exact_snippets": "Excluding ... other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity",
"criterion": "other abnormalities",
"requirement": {
"requirement_type": "assessment",
"expected_value": "outweigh the risk of toxicity"
}
}
]
}
}
]
},
{
"exact_snippets": "all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0)",
"criterion": "reversible toxicity of previous antitumor therapy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "CTCAE V5.0"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment.",
"criterions": [
{
"exact_snippets": "Active autoimmune diseases",
"criterion": "autoimmune diseases",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "exist within 2 years prior to the first use of the investigational drug",
"criterion": "autoimmune diseases",
"requirement": {
"requirement_type": "existence timeframe",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "require systemic treatment",
"criterion": "autoimmune diseases",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "systemic treatment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Active autoimmune diseases",
"criterion": "autoimmune diseases",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
},
{
"exact_snippets": "exist within 2 years prior to the first use of the investigational drug",
"criterion": "autoimmune diseases",
"requirement": {
"requirement_type": "existence timeframe",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2,
"unit": "years"
}
]
}
}
}
]
},
{
"exact_snippets": "require systemic treatment",
"criterion": "autoimmune diseases",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "systemic treatment"
}
}
]
}
},
{
"identified_line": {
"line": "* Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) >2000 IU/ mL or 10^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive",
"criterions": [
{
"exact_snippets": "positive antibodies to HIV",
"criterion": "HIV antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Treponema pallidum antibody positive",
"criterion": "Treponema pallidum antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HBsAg positive",
"criterion": "HBsAg",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
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