Back to resultsTargeted Internal Radiation Therapy in Advanced HCC Patients.
Primary Purpose
Internal Radiation, Advanced Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
131I-chTNT-1/B
Sponsored by
About this trial
This is an interventional treatment trial for Internal Radiation focused on measuring 131I-chTNT-1/B treatment
Eligibility Criteria
Inclusion Criteria:
- Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma
- mRECIST estimation: necrosis region in HCC
- Negative iodine allergy test
- Liver function ：Child-Pugh A/B
Exclusion Criteria:
- reject to attend；
- impossible to come to our hospital for physical examination regularly.
- Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
Sites / Locations
- Eastern hepatobilliary surgery hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
transcatheter arterial chemoembolization
internal radiation group
Arm Description
Patients will be treated with TACE only.
Patients will be treated with TACE combined with internal radiation.
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Time to Progression
Full Information
NCT ID
NCT02724267
First Posted
March 28, 2016
Last Updated
March 28, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02724267
Brief Title
Targeted Internal Radiation Therapy in Advanced HCC Patients.
Official Title
A Randomized Controlled Prospective Study of Targeted Internal Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of individual therapy using randomized controlled study, in order to acquire the evidence of evidence-based medicine and create a new program of targeted internal radiation therapy in advanced HCC patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internal Radiation, Advanced Hepatocellular Carcinoma
Keywords
131I-chTNT-1/B treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transcatheter arterial chemoembolization
Arm Type
Active Comparator
Arm Description
Patients will be treated with TACE only.
Arm Title
internal radiation group
Arm Type
Experimental
Arm Description
Patients will be treated with TACE combined with internal radiation.
Intervention Type
Biological
Intervention Name(s)
131I-chTNT-1/B
Intervention Description
29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Time to Progression
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma
mRECIST estimation: necrosis region in HCC
Negative iodine allergy test
Liver function ：Child-Pugh A/B
Exclusion Criteria:
reject to attend；
impossible to come to our hospital for physical examination regularly.
Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
12. IPD Sharing Statement
Learn more about this trial
Targeted Internal Radiation Therapy in Advanced HCC Patients.
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