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OpenTrials
Completed

NCT Number: NCT02724267

Targeted Internal Radiation Therapy in Advanced HCC Patients.

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.

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Key information

Conditions

Internal Radiation Advanced Hepatocellular Carcinoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

131I-chTNT-1/B

Biological

29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment

Primary outcomes

  1. Overall Survival

    Time frame: 3 years

Secondary outcomes

  1. Time to Progression

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

A Randomized Controlled Prospective Study of Targeted Internal Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2016
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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