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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 April 2016
Main ID:  NCT02724267
Date of registration: 28/03/2016
Prospective Registration: No
Primary sponsor: Eastern Hepatobiliary Surgery Hospital
Public title: Targeted Internal Radiation Therapy in Advanced HCC Patients.
Scientific title: A Randomized Controlled Prospective Study of Targeted Internal Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.
Date of first enrolment: November 2012
Target sample size: 200
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02724267
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
China
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma

2. mRECIST estimation: necrosis region in HCC

3. Negative iodine allergy test

4. Liver function :Child-Pugh A/B

Exclusion Criteria:

1. reject to attend;

2. impossible to come to our hospital for physical examination regularly.

3. Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary,
cerebral and renal dysfunction,which may affect the treatment of liver cancer.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Advanced Hepatocellular Carcinoma
Internal Radiation
Intervention(s)
Biological: 131I-chTNT-1/B
Primary Outcome(s)
Overall Survival [Time Frame: 3 years]
Secondary Outcome(s)
Time to Progression [Time Frame: 3 years]
Secondary ID(s)
ZD201208002-P1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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