ID

36431

Description

Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT01392131 Brief Summary: Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma Detailed Description: To assess therapeutic efficacy and safety of Oncoxin in hepatocellular carcinoma. To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is improved survival in hepatocellular carcinoma patients after administration of oncoxin.

Link

https://clinicaltrials.gov/show/NCT01392131

Keywords

Versions (2)
  1. 1/16/19 1/16/19 -
  2. 5/14/19 5/14/19 -
Copyright Holder

Clinical Research Organization, Dhaka, Bangladesh

Uploaded on

May 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Oncoxin in Hepatocellular Carcinoma NCT01392131

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have HCC (irrespective of etiology, age, gender and status of underlying liver disease)?
Description

The participant should have HCC (irrespective of etiology, age, gender and status of underlying liver disease)

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C3641650
UMLS CUI [1,3]
C1314792
UMLS CUI [1,4]
C0001779
UMLS CUI [1,5]
C0079399
UMLS CUI [1,6]
C0699749
Is the participant not a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy?
Description

The participant (with HCC) shoud not be a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443211
UMLS CUI [1,3]
C1548788
UMLS CUI [2]
C0543467
UMLS CUI [3]
C3665472
Does the participant have HCC with evidence of tumor metastasis?
Description

The participant should have patients HCC with evidence of tumor metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C2239176
Is the participant voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy?
Description

The participant should be voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443211
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C0543467
UMLS CUI [3]
C3665472
Does the participant have exhausted all treatment options?
Description

Participants should have exhausted all treatment options

Data type

boolean

Alias
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0683525
UMLS CUI [1,4]
C0231175
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the participant a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy?
Description

The participant should not be a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443211
UMLS CUI [1,3]
C3900053
UMLS CUI [2]
C0543467
UMLS CUI [3]
C3665472
Does the participant have no evidence of tumor metastasis?
Description

The patient should not be metastasis free

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1298908
Is the participant willing to take established modalities of treatment i.e. surgery and/or chemotherapy?
Description

Willingness for Standard Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0443211
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0543467
UMLS CUI [3]
C3665472
Is the participant voluntarily unwilling to be included in the trial?
Description

Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatocellular Carcinoma
Item
Does the participant have HCC (irrespective of etiology, age, gender and status of underlying liver disease)?
boolean
C2239176 (UMLS CUI [1,1])
C3641650 (UMLS CUI [1,2])
C1314792 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
C0079399 (UMLS CUI [1,5])
C0699749 (UMLS CUI [1,6])
No Treatment Options
Item
Is the participant not a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy?
boolean
C0087111 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C3665472 (UMLS CUI [3])
Metastasis
Item
Does the participant have HCC with evidence of tumor metastasis?
boolean
C0332120 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
Refusal of Standard Treatment
Item
Is the participant voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy?
boolean
C0087111 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C3665472 (UMLS CUI [3])
Treatment exhausted
Item
Does the participant have exhausted all treatment options?
boolean
C0679646 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0683525 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Therapy options available
Item
Is the participant a suitable candidate for established modalities of treatment i.e. surgery and/or chemotherapy?
boolean
C0087111 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C3665472 (UMLS CUI [3])
No Metastasis
Item
Does the participant have no evidence of tumor metastasis?
boolean
C0027627 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Willingness for Standard Treatment
Item
Is the participant willing to take established modalities of treatment i.e. surgery and/or chemotherapy?
boolean
C0600109 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C3665472 (UMLS CUI [3])
Consent
Item
Is the participant voluntarily unwilling to be included in the trial?
boolean
C2348568 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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