{
"info": {
"nct_id": "NCT01795976",
"official_title": "A Phase II Trial to Assess the Activity of NY-ESO-1 Targeted T Cells in Advanced Oesophagogastric Cancer",
"inclusion_criteria": "* Patients must have histologically confirmed oesophagogastric cancer with confirmed evidence of metastatic disease and to have failed or refused standard therapies.\n* There must be measurable disease\n* Patients may have had any previous systemic therapies provided they are otherwise fit for treatment\n* Age equal to or greater than 18 years\n* World Health Organisation (WHO) performance status of 0 or 1\n* Patients must be HLA-A2 positive\n* Their tumour must stain positive by immunohistochemistry for NY-ESO-1 (either diagnostic or more recent biopsy is acceptable)\n* Life expectancy >3months\n* Left ventricular ejection fraction (LVEF) > 50% as measured by ECHO or Multi Gated Acquisition Scan (MUGA)\n* Haematological and biochemical indices:\n* Haemoglobin (Hb) ≥ 8.0 g/dL\n* Neutrophils ≥ 1.0 x 10*9/L\n* Platelets (Plts) ≥ 100 x 10*9/L\n* Any of the following abnormal baseline liver function tests:\n* serum bilirubin ≤ 20 mmol/l (ULN)\n* alanine aminotransferase (ALT) and/or\n* aspartate aminotransferase (AST) and/or\n* ≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN.\n* Serum creatinine ≤ 0.15 mmol/L or creatinine clearance > 50 ml/min\n* These measurements must be performed prior to leukaphereses and again prior to commencing preconditioning chemotherapy.\n* The chemotherapy to be used in this trial is non-myeloablative, but where patients have had previous high dose chemotherapy, an autologous haemopoietic stem cell backup harvest, for stem cell rescue, will be obtained prior to commencing therapy in this trial. Similarly, where there is concern about a patient's bone marrow reserves, for example due to multiple previous lines of myelosuppressive chemotherapy a backup stem cell harvest should also be obtained.\n* Female patients of child-bearing potential must have a negative serum or urine pregnancy test prior treatment and agree to use appropriate medically approved contraceptive precautions for four weeks prior to entering the trial, during the trial, and for six months afterwards.\n* Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.\n* Able to provide full written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Those receiving radiotherapy, biological therapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment.\n* All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities, which an investigator considers should not exclude the patient.\n* Participation in any other clinical trial within the previous 30 days or during the course of this treatment.\n* Previous allogeneic transplant.\n* Clinically significant cardiac disease.\n* Patients who are high medical risks because of non-malignant systemic disease, including those with active infection, uncontrolled cardiac or respiratory disease, or other serious medical or psychiatric disorders which in the lead clinicians opinion would not make the patient a good candidate for adoptive T-cell therapy.\n* Concurrent serious infections within the 28 days prior to treatment\n* Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.\n* Patients known or found to be serologically positive for Hepatitis B, C, HIV or Human T cell lymphotropic Virus (HTLV).\n* History of systemic autoimmune disease which could be life-threatening if reactivation occurred( for example hypothyroidism would be permissible, prior rheumatoid arthritis or systemic lupus erythematosus (SLE0 would not).\n* Evidence of Centra Nervous System (CNS) involvement.\n* Patients who are likely to require systemic steroids or other immunosuppressive therapy.\n* Pregnant and lactating women.\n* Radiotherapy to >25% skeleton.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* There must be measurable disease",
"criterions": [
{
"exact_snippets": "measurable disease",
"criterion": "disease",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "measurable disease",
"criterion": "disease",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients may have had any previous systemic therapies provided they are otherwise fit for treatment",
"criterions": [
{
"exact_snippets": "Patients may have had any previous systemic therapies",
"criterion": "previous systemic therapies",
"requirement": {
"requirement_type": "history",
"expected_value": "any"
}
},
{
"exact_snippets": "provided they are otherwise fit for treatment",
"criterion": "fitness for treatment",
"requirement": {
"requirement_type": "fitness",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Patients may have had any previous systemic therapies",
"criterion": "previous systemic therapies",
"requirement": {
"requirement_type": "history",
"expected_value": "any"
}
},
"then_criteria": {
"exact_snippets": "provided they are otherwise fit for treatment",
"criterion": "fitness for treatment",
"requirement": {
"requirement_type": "fitness",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Age equal to or greater than 18 years",
"criterions": [
{
"exact_snippets": "Age equal to or greater than 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age equal to or greater than 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must be HLA-A2 positive",
"criterions": [
{
"exact_snippets": "HLA-A2 positive",
"criterion": "HLA-A2",
"requirement": {
"requirement_type": "presence",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "HLA-A2 positive",
"criterion": "HLA-A2",
"requirement": {
"requirement_type": "presence",
"expected_value": "positive"
}
}
]
}
},
{
"identified_line": {
"line": "* Their tumour must stain positive by immunohistochemistry for NY-ESO-1 (either diagnostic or more recent biopsy is acceptable)",
"criterions": [
{
"exact_snippets": "tumour must stain positive by immunohistochemistry for NY-ESO-1",
"criterion": "NY-ESO-1 staining",
"requirement": {
"requirement_type": "result",
"expected_value": "positive"
}
},
{
"exact_snippets": "either diagnostic or more recent biopsy is acceptable",
"criterion": "biopsy recency",
"requirement": {
"requirement_type": "recency",
"expected_value": [
"diagnostic",
"more recent"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "tumour must stain positive by immunohistochemistry for NY-ESO-1",
"criterion": "NY-ESO-1 staining",
"requirement": {
"requirement_type": "result",
"expected_value": "positive"
}
},
{
"exact_snippets": "either diagnostic or more recent biopsy is acceptable",
"criterion": "biopsy recency",
"requirement": {
"requirement_type": "recency",
"expected_value": [
"diagnostic",
"more recent"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy >3months",
"criterions": [
{
"exact_snippets": "Life expectancy >3months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy >3months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Haematological and biochemical indices:",
"criterions": [
{
"exact_snippets": "Haematological and biochemical indices",
"criterion": "haematological indices",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
},
{
"exact_snippets": "Haematological and biochemical indices",
"criterion": "biochemical indices",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Haematological and biochemical indices",
"criterion": "haematological indices",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
},
{
"exact_snippets": "Haematological and biochemical indices",
"criterion": "biochemical indices",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Haemoglobin (Hb) ≥ 8.0 g/dL",
"criterions": [
{
"exact_snippets": "Haemoglobin (Hb) ≥ 8.0 g/dL",
"criterion": "haemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 8.0,
"unit": "g/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Haemoglobin (Hb) ≥ 8.0 g/dL",
"criterion": "haemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 8.0,
"unit": "g/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Neutrophils ≥ 1.0 x 10*9/L",
"criterions": [
{
"exact_snippets": "Neutrophils ≥ 1.0 x 10*9/L",
"criterion": "neutrophils",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.0,
"unit": "x 10*9/L"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Neutrophils ≥ 1.0 x 10*9/L",
"criterion": "neutrophils",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.0,
"unit": "x 10*9/L"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelets (Plts) ≥ 100 x 10*9/L",
"criterions": [
{
"exact_snippets": "Platelets (Plts) ≥ 100 x 10*9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x 10*9/L"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelets (Plts) ≥ 100 x 10*9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x 10*9/L"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Any of the following abnormal baseline liver function tests:",
"criterions": [
{
"exact_snippets": "abnormal baseline liver function tests",
"criterion": "liver function tests",
"requirement": {
"requirement_type": "status",
"expected_value": "abnormal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "abnormal baseline liver function tests",
"criterion": "liver function tests",
"requirement": {
"requirement_type": "status",
"expected_value": "abnormal"
}
}
]
}
},
{
"identified_line": {
"line": "* alanine aminotransferase (ALT) and/or",
"criterions": [
{
"exact_snippets": "alanine aminotransferase (ALT)",
"criterion": "alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "alanine aminotransferase (ALT)",
"criterion": "alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* aspartate aminotransferase (AST) and/or",
"criterions": [
{
"exact_snippets": "aspartate aminotransferase (AST)",
"criterion": "aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "aspartate aminotransferase (AST)",
"criterion": "aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* ≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN.",
"criterions": [
{
"exact_snippets": "≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN",
"criterion": "liver function test",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "x ULN"
}
]
}
}
},
{
"exact_snippets": "≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN",
"criterion": "liver function test",
"requirement": {
"requirement_type": "condition",
"expected_value": "liver metastases"
}
},
{
"exact_snippets": "≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN",
"criterion": "liver function test",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 5,
"unit": "x ULN"
}
]
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN",
"criterion": "liver function test",
"requirement": {
"requirement_type": "condition",
"expected_value": "liver metastases"
}
},
"then_criteria": {
"exact_snippets": "≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN",
"criterion": "liver function test",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 5,
"unit": "x ULN"
}
]
}
}
},
"else_criteria": {
"exact_snippets": "≤ 3 x ULN unless patient has liver metastases when can be < 5 x ULN",
"criterion": "liver function test",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "x ULN"
}
]
}
}
}
}
},
{
"identified_line": {
"line": "* These measurements must be performed prior to leukaphereses and again prior to commencing preconditioning chemotherapy.",
"criterions": [
{
"exact_snippets": "These measurements must be performed prior to leukaphereses",
"criterion": "measurements prior to leukaphereses",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to leukaphereses"
}
},
{
"exact_snippets": "These measurements must be performed ... again prior to commencing preconditioning chemotherapy",
"criterion": "measurements prior to preconditioning chemotherapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to preconditioning chemotherapy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "These measurements must be performed prior to leukaphereses",
"criterion": "measurements prior to leukaphereses",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to leukaphereses"
}
},
{
"exact_snippets": "These measurements must be performed ... again prior to commencing preconditioning chemotherapy",
"criterion": "measurements prior to preconditioning chemotherapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to preconditioning chemotherapy"
}
}
]
}
},
{
"identified_line": {
"line": "* The chemotherapy to be used in this trial is non-myeloablative, but where patients have had previous high dose chemotherapy, an autologous haemopoietic stem cell backup harvest, for stem cell rescue, will be obtained prior to commencing therapy in this trial. Similarly, where there is concern about a patient's bone marrow reserves, for example due to multiple previous lines of myelosuppressive chemotherapy a backup stem cell harvest should also be obtained.",
"criterions": [
{
"exact_snippets": "patients have had previous high dose chemotherapy",
"criterion": "previous high dose chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "concern about a patient's bone marrow reserves",
"criterion": "bone marrow reserves",
"requirement": {
"requirement_type": "concern",
"expected_value": true
}
},
{
"exact_snippets": "multiple previous lines of myelosuppressive chemotherapy",
"criterion": "previous lines of myelosuppressive chemotherapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": "multiple"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"condition": {
"and_criteria": [
{
"exact_snippets": "patients have had previous high dose chemotherapy",
"criterion": "previous high dose chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"then_criteria": {
"exact_snippets": "autologous haemopoietic stem cell backup harvest, for stem cell rescue, will be obtained prior to commencing therapy in this trial",
"criterion": "autologous haemopoietic stem cell backup harvest",
"requirement": {
"requirement_type": "obtained",
"expected_value": true
}
},
"else_criteria": null
},
{
"condition": {
"or_criteria": [
{
"exact_snippets": "concern about a patient's bone marrow reserves",
"criterion": "bone marrow reserves",
"requirement": {
"requirement_type": "concern",
"expected_value": true
}
},
{
"exact_snippets": "multiple previous lines of myelosuppressive chemotherapy",
"criterion": "previous lines of myelosuppressive chemotherapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": "multiple"
}
}
]
},
"then_criteria": {
"exact_snippets": "backup stem cell harvest should also be obtained",
"criterion": "backup stem cell harvest",
"requirement": {
"requirement_type": "obtained",
"expected_value": true
}
},
"else_criteria": null
}
]
}
},
{
"identified_line": {
"line": "* Female patients of child-bearing potential must have a negative serum or urine pregnancy test prior treatment and agree to use appropriate medically approved contraceptive precautions for four weeks prior to entering the trial, during the trial, and for six months afterwards.",
"criterions": [
{
"exact_snippets": "Female patients of child-bearing potential",
"criterion": "gender and reproductive potential",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
},
{
"exact_snippets": "Female patients of child-bearing potential",
"criterion": "gender and reproductive potential",
"requirement": {
"requirement_type": "reproductive potential",
"expected_value": "child-bearing potential"
}
},
{
"exact_snippets": "negative serum or urine pregnancy test",
"criterion": "pregnancy test result",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "agree to use appropriate medically approved contraceptive precautions",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "agree to use appropriate medically approved contraceptive precautions",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "duration",
"expected_value": "four weeks prior to entering the trial, during the trial, and for six months afterwards"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Female patients of child-bearing potential",
"criterion": "gender and reproductive potential",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
},
{
"exact_snippets": "Female patients of child-bearing potential",
"criterion": "gender and reproductive potential",
"requirement": {
"requirement_type": "reproductive potential",
"expected_value": "child-bearing potential"
}
}
]
},
{
"exact_snippets": "negative serum or urine pregnancy test",
"criterion": "pregnancy test result",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"and_criteria": [
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"exact_snippets": "agree to use appropriate medically approved contraceptive precautions",
"criterion": "contraceptive use",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "agree to use appropriate medically approved contraceptive precautions",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "duration",
"expected_value": "four weeks prior to entering the trial, during the trial, and for six months afterwards"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.",
"criterions": [
{
"exact_snippets": "Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.",
"criterion": "contraception",
"requirement": {
"requirement_type": "method",
"expected_value": "barrier method"
}
},
{
"exact_snippets": "Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.",
"criterion": "contraception",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the treatment and for six months afterwards"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.",
"criterion": "contraception",
"requirement": {
"requirement_type": "method",
"expected_value": "barrier method"
}
},
{
"exact_snippets": "Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.",
"criterion": "contraception",
"requirement": {
"requirement_type": "duration",
"expected_value": "during the treatment and for six months afterwards"
}
}
]
}
},
{
"identified_line": {
"line": "* Able to provide full written informed consent.",
"criterions": [
{
"exact_snippets": "Able to provide full written informed consent.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to provide full written informed consent.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Clinically significant cardiac disease.",
"criterions": [
{
"exact_snippets": "Clinically significant cardiac disease",
"criterion": "cardiac disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Clinically significant cardiac disease",
"criterion": "cardiac disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
}
}
},
{
"identified_line": {
"line": "* Patients who are high medical risks because of non-malignant systemic disease, including those with active infection, uncontrolled cardiac or respiratory disease, or other serious medical or psychiatric disorders which in the lead clinicians opinion would not make the patient a good candidate for adoptive T-cell therapy.",
"criterions": [
{
"exact_snippets": "high medical risks because of non-malignant systemic disease",
"criterion": "non-malignant systemic disease",
"requirement": {
"requirement_type": "risk level",
"expected_value": "high"
}
},
{
"exact_snippets": "active infection",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "uncontrolled cardiac or respiratory disease",
"criterion": "cardiac disease",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "uncontrolled cardiac or respiratory disease",
"criterion": "respiratory disease",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "serious medical or psychiatric disorders",
"criterion": "medical or psychiatric disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "high medical risks because of non-malignant systemic disease",
"criterion": "non-malignant systemic disease",
"requirement": {
"requirement_type": "risk level",
"expected_value": "high"
}
},
{
"exact_snippets": "serious medical or psychiatric disorders",
"criterion": "medical or psychiatric disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
}
]
},
{
"exact_snippets": "active infection",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "uncontrolled cardiac or respiratory disease",
"criterion": "cardiac disease",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "uncontrolled cardiac or respiratory disease",
"criterion": "respiratory disease",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
}
]
}
},
{
"identified_line": {
"line": "* Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.",
"criterions": [
{
"exact_snippets": "Current malignancies at other sites",
"criterion": "current malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "adequately treated cone-biopsied in situ carcinoma of the cervix uteri",
"criterion": "in situ carcinoma of the cervix uteri",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
},
{
"exact_snippets": "basal or squamous cell carcinoma of the skin",
"criterion": "basal or squamous cell carcinoma of the skin",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"not_criteria": {
"exact_snippets": "Current malignancies at other sites",
"criterion": "current malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"or_criteria": [
{
"exact_snippets": "adequately treated cone-biopsied in situ carcinoma of the cervix uteri",
"criterion": "in situ carcinoma of the cervix uteri",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
},
{
"exact_snippets": "basal or squamous cell carcinoma of the skin",
"criterion": "basal or squamous cell carcinoma of the skin",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients known or found to be serologically positive for Hepatitis B, C, HIV or Human T cell lymphotropic Virus (HTLV).",
"criterions": [
{
"exact_snippets": "serologically positive for Hepatitis B",
"criterion": "Hepatitis B",
"requirement": {
"requirement_type": "serological status",
"expected_value": "positive"
}
},
{
"exact_snippets": "serologically positive for ... C",
"criterion": "Hepatitis C",
"requirement": {
"requirement_type": "serological status",
"expected_value": "positive"
}
},
{
"exact_snippets": "serologically positive for ... HIV",
"criterion": "HIV",
"requirement": {
"requirement_type": "serological status",
"expected_value": "positive"
}
},
{
"exact_snippets": "serologically positive for ... Human T cell lymphotropic Virus (HTLV)",
"criterion": "Human T cell lymphotropic Virus (HTLV)",
"requirement": {
"requirement_type": "serological status",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "serologically positive for Hepatitis B",
"criterion": "Hepatitis B",
"requirement": {
"requirement_type": "serological status",
"expected_value": "positive"
}
},
{
"exact_snippets": "serologically positive for ... C",
"criterion": "Hepatitis C",
"requirement": {
"requirement_type": "serological status",
"expected_value": "positive"
}
},
{
"exact_snippets": "serologically positive for ... HIV",
"criterion": "HIV",
"requirement": {
"requirement_type": "serological status",
"expected_value": "positive"
}
},
{
"exact_snippets": "serologically positive for ... Human T cell lymphotropic Virus (HTLV)",
"criterion": "Human T cell lymphotropic Virus (HTLV)",
"requirement": {
"requirement_type": "serological status",
"expected_value": "positive"
}
}
]
}
},
{
"identified_line": {
"line": "* Evidence of Centra Nervous System (CNS) involvement.",
"criterions": [
{
"exact_snippets": "Evidence of Centra Nervous System (CNS) involvement",
"criterion": "CNS involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Evidence of Centra Nervous System (CNS) involvement",
"criterion": "CNS involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patients who are likely to require systemic steroids or other immunosuppressive therapy.",
"criterions": [
{
"exact_snippets": "likely to require systemic steroids",
"criterion": "systemic steroids",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "likely to require ... other immunosuppressive therapy",
"criterion": "immunosuppressive therapy",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "likely to require systemic steroids",
"criterion": "systemic steroids",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "likely to require ... other immunosuppressive therapy",
"criterion": "immunosuppressive therapy",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnant and lactating women.",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Radiotherapy to >25% skeleton.",
"criterions": [
{
"exact_snippets": "Radiotherapy to >25% skeleton.",
"criterion": "radiotherapy to skeleton",
"requirement": {
"requirement_type": "extent",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Radiotherapy to >25% skeleton.",
"criterion": "radiotherapy to skeleton",
"requirement": {
"requirement_type": "extent",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "%"
}
}
}
}
},
{
"identified_line": {
"line": "* History of systemic autoimmune disease which could be life-threatening if reactivation occurred( for example hypothyroidism would be permissible, prior rheumatoid arthritis or systemic lupus erythematosus (SLE0 would not).",
"criterions": [
{
"exact_snippets": "History of systemic autoimmune disease",
"criterion": "systemic autoimmune disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "could be life-threatening if reactivation occurred",
"criterion": "reactivation risk",
"requirement": {
"requirement_type": "severity",
"expected_value": "life-threatening"
}
},
{
"exact_snippets": "hypothyroidism would be permissible",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "permissibility",
"expected_value": true
}
},
{
"exact_snippets": "prior rheumatoid arthritis or systemic lupus erythematosus (SLE) would not",
"criterion": "rheumatoid arthritis or systemic lupus erythematosus (SLE)",
"requirement": {
"requirement_type": "permissibility",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of systemic autoimmune disease",
"criterion": "systemic autoimmune disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "could be life-threatening if reactivation occurred",
"criterion": "reactivation risk",
"requirement": {
"requirement_type": "severity",
"expected_value": "life-threatening"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "prior rheumatoid arthritis or systemic lupus erythematosus (SLE) would not",
"criterion": "rheumatoid arthritis or systemic lupus erythematosus (SLE)",
"requirement": {
"requirement_type": "permissibility",
"expected_value": false
}
},
{
"not_criteria": {
"exact_snippets": "hypothyroidism would be permissible",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "permissibility",
"expected_value": true
}
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patients must have histologically confirmed oesophagogastric cancer with confirmed evidence of metastatic disease and to have failed or refused standard therapies.",
"criterions": [
{
"exact_snippets": "histologically confirmed oesophagogastric cancer",
"criterion": "oesophagogastric cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "confirmed evidence of metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "confirmed evidence"
}
},
{
"exact_snippets": "failed or refused standard therapies",
"criterion": "standard therapies",
"requirement": {
"requirement_type": "status",
"expected_value": [
"failed",
"refused"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "histologically confirmed oesophagogastric cancer",
"criterion": "oesophagogastric cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "confirmed evidence of metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "confirmed evidence"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "failed or refused standard therapies",
"criterion": "standard therapies",
"requirement": {
"requirement_type": "status",
"expected_value": "failed"
}
},
{
"exact_snippets": "failed or refused standard therapies",
"criterion": "standard therapies",
"requirement": {
"requirement_type": "status",
"expected_value": "refused"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* World Health Organisation (WHO) performance status of 0 or 1",
"criterions": [
{
"exact_snippets": "World Health Organisation (WHO) performance status of 0 or 1",
"criterion": "WHO performance status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "World Health Organisation (WHO) performance status of 0 or 1",
"criterion": "WHO performance status",
"requirement": {
"requirement_type": "status",
"expected_value": "0"
}
},
{
"exact_snippets": "World Health Organisation (WHO) performance status of 0 or 1",
"criterion": "WHO performance status",
"requirement": {
"requirement_type": "status",
"expected_value": "1"
}
}
]
}
},
{
"identified_line": {
"line": "* Left ventricular ejection fraction (LVEF) > 50% as measured by ECHO or Multi Gated Acquisition Scan (MUGA)",
"criterions": [
{
"exact_snippets": "Left ventricular ejection fraction (LVEF) > 50%",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "measurement",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "as measured by ECHO or Multi Gated Acquisition Scan (MUGA)",
"criterion": "measurement method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"ECHO",
"Multi Gated Acquisition Scan (MUGA)"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Left ventricular ejection fraction (LVEF) > 50%",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "measurement",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "%"
}
}
},
{
"or_criteria": [
{
"exact_snippets": "as measured by ECHO or Multi Gated Acquisition Scan (MUGA)",
"criterion": "measurement method",
"requirement": {
"requirement_type": "method",
"expected_value": "ECHO"
}
},
{
"exact_snippets": "as measured by ECHO or Multi Gated Acquisition Scan (MUGA)",
"criterion": "measurement method",
"requirement": {
"requirement_type": "method",
"expected_value": "Multi Gated Acquisition Scan (MUGA)"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* serum bilirubin ≤ 20 mmol/l (ULN)",
"criterions": [
{
"exact_snippets": "serum bilirubin ≤ 20 mmol/l",
"criterion": "serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 20,
"unit": "mmol/l"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "serum bilirubin \u0010 20 mmol/l",
"criterion": "serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 20,
"unit": "mmol/l"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum creatinine ≤ 0.15 mmol/L or creatinine clearance > 50 ml/min",
"criterions": [
{
"exact_snippets": "Serum creatinine ≤ 0.15 mmol/L",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 0.15,
"unit": "mmol/L"
}
}
},
{
"exact_snippets": "creatinine clearance > 50 ml/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "rate",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "ml/min"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Serum creatinine \u0010.15 mmol/L",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 0.15,
"unit": "mmol/L"
}
}
},
{
"exact_snippets": "creatinine clearance > 50 ml/min",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "rate",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "ml/min"
}
}
}
]
}
},
{
"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": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"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": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities, which an investigator considers should not exclude the patient.",
"criterions": [
{
"exact_snippets": "All toxic manifestations of previous treatment must have resolved.",
"criterion": "toxic manifestations of previous treatment",
"requirement": {
"requirement_type": "resolution",
"expected_value": true
}
},
{
"exact_snippets": "alopecia",
"criterion": "alopecia",
"requirement": {
"requirement_type": "exclusion",
"expected_value": false
}
},
{
"exact_snippets": "certain Grade 1 toxicities, which an investigator considers should not exclude the patient.",
"criterion": "Grade 1 toxicities",
"requirement": {
"requirement_type": "exclusion",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Participation in any other clinical trial within the previous 30 days or during the course of this treatment.",
"criterions": [
{
"exact_snippets": "Participation in any other clinical trial within the previous 30 days",
"criterion": "participation in other clinical trial",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
},
{
"exact_snippets": "Participation in any other clinical trial ... during the course of this treatment",
"criterion": "participation in other clinical trial",
"requirement": {
"requirement_type": "time frame",
"expected_value": "during the course of this treatment"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Previous allogeneic transplant.",
"criterions": [
{
"exact_snippets": "Previous allogeneic transplant",
"criterion": "allogeneic transplant",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Concurrent serious infections within the 28 days prior to treatment",
"criterions": [
{
"exact_snippets": "Concurrent serious infections within the 28 days prior to treatment",
"criterion": "serious infections",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Concurrent serious infections within the 28 days prior to treatment",
"criterion": "serious infections",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within the 28 days prior to treatment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Concurrent serious infections within the 28 days prior to treatment",
"criterion": "serious infections",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Concurrent serious infections within the 28 days prior to treatment",
"criterion": "serious infections",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within the 28 days prior to treatment"
}
}
]
}
},
{
"identified_line": {
"line": "* Those receiving radiotherapy, biological therapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment.",
"criterions": [
{
"exact_snippets": "receiving radiotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving biological therapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "biological therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving endocrine therapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "endocrine therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving immunotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving systemic steroids ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "systemic steroids",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving chemotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving nitrosoureas ... during the previous six weeks ... prior to treatment or during the course of the treatment",
"criterion": "nitrosoureas",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving Mitomycin-C ... during the previous six weeks ... prior to treatment or during the course of the treatment",
"criterion": "Mitomycin-C",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "weeks"
}
]
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "receiving radiotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving radiotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": "during the course of the treatment"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "receiving biological therapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "biological therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving biological therapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "biological therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": "during the course of the treatment"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "receiving endocrine therapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "endocrine therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving endocrine therapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "endocrine therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": "during the course of the treatment"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "receiving immunotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving immunotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": "during the course of the treatment"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "receiving systemic steroids ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "systemic steroids",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving systemic steroids ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "systemic steroids",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": "during the course of the treatment"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "receiving chemotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving chemotherapy ... during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": "during the course of the treatment"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "receiving nitrosoureas ... during the previous six weeks ... prior to treatment or during the course of the treatment",
"criterion": "nitrosoureas",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 6,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving nitrosoureas ... during the previous six weeks ... prior to treatment or during the course of the treatment",
"criterion": "nitrosoureas",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": "during the course of the treatment"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "receiving Mitomycin-C ... during the previous six weeks ... prior to treatment or during the course of the treatment",
"criterion": "Mitomycin-C",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 6,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "receiving Mitomycin-C ... during the previous six weeks ... prior to treatment or during the course of the treatment",
"criterion": "Mitomycin-C",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": "during the course of the treatment"
}
}
]
}
]
}
}
],
"failed_miscellaneous": []
}