Internal RadiationNCT02724267
Targeted Internal Radiation Therapy in Advanced HCC Patients.
A study testing 131I-chTNT-1/B in people with Internal Radiation and Advanced Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Internal Radiation, Advanced Hepatocellular Carcinoma
- What is being tested?
- 131I-chTNT-1/B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Dec 2015
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: A Randomized Controlled Prospective Study of Targeted Internal Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.
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.
- Being tested
- 131I-chTNT-1/B
- Keywords
- 131I-chTNT-1/B treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-chTNT-1/BBiological
29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment
| Study group | Role | What they receive |
|---|---|---|
| transcatheter arterial chemoembolization | Active comparator | Patients will be treated with TACE only. Receives: Biological: 131I-chTNT-1/B |
| internal radiation group | Experimental | Patients will be treated with TACE combined with internal radiation. Receives: Biological: 131I-chTNT-1/B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 3 years
Secondary outcomes (1)
Time to Progression
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724267
- Sponsor's protocol ID
- ZD201208002-P1
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes