Targeted Internal Radiation Therapy in Advanced HCC Patients.

March 28, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transcatheter arterial chemoembolization
Patients will be treated with TACE only.
Biological: 131I-chTNT-1/B
29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment
Experimental: internal radiation group
Patients will be treated with TACE combined with internal radiation.
Biological: 131I-chTNT-1/B
29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Progression
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZD201208002-P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Hepatocellular Carcinoma

Clinical Trials on 131I-chTNT-1/B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe