ID

44514

Beschreibung

Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab in Subjects With Advanced Liver Cancer Anti-PD-1 HCC (Anti-Programmed-Death-1 Hepatocellular Carcinoma); ODM derived from: https://clinicaltrials.gov/show/NCT01658878

Link

https://clinicaltrials.gov/show/NCT01658878

Stichworte

Versionen (2)
  1. 20.02.20 20.02.20 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01658878

Englisch

Eligibility Hepatocellular Carcinoma NCT01658878

1 Formulare  
Criteria
Beschreibung

Criteria

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects of 18 years or older (men and women) with histological confirmation of advanced hepatocellular carcinoma
Beschreibung

Age | Liver carcinoma Advanced

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0205179
eastern cooperative oncology group (ecog) performance status of 0 to 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
for the dose escalation cohorts (uninfected, hcv-infected, and hbv-infected): subjects must have progressive disease following or be intolerant of at least one line of systemic therapy or refuse sorafenib treatment
Beschreibung

Dose Escalation Cohort | Infection Absent | Hepatitis C | Hepatitis B | Progressive Disease | Intolerance Systemic therapy Quantity | Sorafenib Refused

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3816728
UMLS CUI [1,2]
C0599755
UMLS CUI [2,1]
C3714514
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019163
UMLS CUI [5]
C1335499
UMLS CUI [6,1]
C0231199
UMLS CUI [6,2]
C1515119
UMLS CUI [6,3]
C1265611
UMLS CUI [7,1]
C1516119
UMLS CUI [7,2]
C1705116
for the uninfected sorafenib naive or intolerant hcc expansion cohort, subjects must either never have received sorafenib treatment or were intolerant to sorafenib therapy
Beschreibung

Infection Absent | Sorafenib Absent | Intolerance to Sorafenib | Liver carcinoma Expansion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1516119
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C1516119
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C1519678
for the uninfected sorafenib failure hcc expansion cohort, subjects must have had documented radiographic or symptomatic progression during or after sorafenib therapy
Beschreibung

Infection Absent | Sorafenib failed | Liver carcinoma Expansion | Disease Progression Radiography | Disease Progression Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1516119
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C1519678
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0043299
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0231220
dose escalation phase: child-pugh score of 7 points or less, i.e., child-pugh a or child pugh b7
Beschreibung

Dose Escalation Phase | Child-Pugh Score | Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3816728
UMLS CUI [1,2]
C1710475
UMLS CUI [2]
C4055253
UMLS CUI [3]
C4050412
expansion phase: child-pugh score of 6 points or less, i.e., child-pugh a
Beschreibung

Expansion Phase | Child-Pugh Score | Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519678
UMLS CUI [1,2]
C1710475
UMLS CUI [2]
C4055253
UMLS CUI [3]
C4050412
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with brain metasteses
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
any prior or current clinically significant ascites as measured by physical examination and that requires active parancentesis for control
Beschreibung

Ascites Physical Examination | Paracentesis Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C0034115
UMLS CUI [2,2]
C1514873
any history of clinically meaningful variceal bleeding within the last three months
Beschreibung

Bleeding varices

Datentyp

boolean

Alias
UMLS CUI [1]
C0333106
active coinfection with both hepatitis b and c
Beschreibung

HBV coinfection | HCV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C1698259
hepatitis d infection in subjects with hepatitis b
Beschreibung

Hepatitis D Infection In addition to Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011226
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0019163
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT01658878

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Age | Liver carcinoma Advanced
Item
subjects of 18 years or older (men and women) with histological confirmation of advanced hepatocellular carcinoma
boolean
C0001779 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Dose Escalation Cohort | Infection Absent | Hepatitis C | Hepatitis B | Progressive Disease | Intolerance Systemic therapy Quantity | Sorafenib Refused
Item
for the dose escalation cohorts (uninfected, hcv-infected, and hbv-infected): subjects must have progressive disease following or be intolerant of at least one line of systemic therapy or refuse sorafenib treatment
boolean
C3816728 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C3714514 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C1335499 (UMLS CUI [5])
C0231199 (UMLS CUI [6,1])
C1515119 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C1516119 (UMLS CUI [7,1])
C1705116 (UMLS CUI [7,2])
Infection Absent | Sorafenib Absent | Intolerance to Sorafenib | Liver carcinoma Expansion
Item
for the uninfected sorafenib naive or intolerant hcc expansion cohort, subjects must either never have received sorafenib treatment or were intolerant to sorafenib therapy
boolean
C3714514 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1516119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C1519678 (UMLS CUI [4,2])
Infection Absent | Sorafenib failed | Liver carcinoma Expansion | Disease Progression Radiography | Disease Progression Symptomatic
Item
for the uninfected sorafenib failure hcc expansion cohort, subjects must have had documented radiographic or symptomatic progression during or after sorafenib therapy
boolean
C3714514 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1516119 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C1519678 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
Dose Escalation Phase | Child-Pugh Score | Child-Pugh Classification
Item
dose escalation phase: child-pugh score of 7 points or less, i.e., child-pugh a or child pugh b7
boolean
C3816728 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
C4055253 (UMLS CUI [2])
C4050412 (UMLS CUI [3])
Expansion Phase | Child-Pugh Score | Child-Pugh Classification
Item
expansion phase: child-pugh score of 6 points or less, i.e., child-pugh a
boolean
C1519678 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
C4055253 (UMLS CUI [2])
C4050412 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
subjects with brain metasteses
boolean
C0220650 (UMLS CUI [1])
Ascites Physical Examination | Paracentesis Required
Item
any prior or current clinically significant ascites as measured by physical examination and that requires active parancentesis for control
boolean
C0003962 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0034115 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Bleeding varices
Item
any history of clinically meaningful variceal bleeding within the last three months
boolean
C0333106 (UMLS CUI [1])
HBV coinfection | HCV coinfection
Item
active coinfection with both hepatitis b and c
boolean
C2242656 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
Hepatitis D Infection In addition to Hepatitis B
Item
hepatitis d infection in subjects with hepatitis b
boolean
C0011226 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
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